MAIN5 and ACCURIDS Forge Partnership to Leverage Data-Driven Decision Making in Pharma

MAIN5 GmbH & Co. KGaA, a leader in pharmaceutical consultancy, and ACCURIDS GmbH, a pioneer in enterprise data registration, have announced a groundbreaking partnership. This partnership is dedicated to advancing data governance in pharmaceutical research and development based on the FAIR data concept, ensuring data is Findable, Accessible, Interoperable, and Reusable.


This collaboration is a synergistic merge of MAIN5's expertise in pharmaceutical processes, data flows and corresponding IT systems with ACCURIDS' innovative solution for lean enterprise data governance. It focuses on continuously optimizing data connectivity and use within pharma R&D and across Manufacturing/Supply, Safety, and Quality. The value for our clients lies in making data easily accessible across both internal and external sources and systems, enabling them to rely on this data for improved and faster decision-making, Health Authority Reporting, support in data migration for system replacements, and much more.

A key component for the start of this partnership is a comprehensive industry benchmark survey on FAIR data management maturity focused on medicinal product data. This assessment will provide valuable insights into the current state of data management in pharma R&D, identifying areas for improvement and innovation. The findings of this assessment are guiding the development of new tools and methodologies that will transform data handling in the pharmaceutical industry.

“We are excited to share our strategic focus on robust data governance and the implementation of FAIR data principles. By seamlessly bringing together data from departments that typically exist in silos, we not only ensure the ethical and transparent handling of data but also empower cross-functional collaboration and decision making. Transparent data across the pharmaceutical value chain will drive success and innovation.”, said Karsten Krüger, Managing Partner and Co-Founder of MAIN5 GmbH & Co. KGaA.

Heiner Oberkampf, CEO and Co-Founder of ACCURIDS, commented, "Our collaboration with MAIN5 is a significant step to provide a comprehensive and business-driven data strategy implementation to our pharma customers."

With this partnership, MAIN5 and ACCURIDS are helping clients to create business value through incremental rapid implementation of a broad range of use cases embedded in a long-term digital strategy, that ultimately leads to a fully data-driven organization.


About MAIN5 GmbH & Co. KGaA

MAIN5 GmbH & Co. KGaA is an independent and successful management consulting company headquartered in Frankfurt am Main, Germany. We solve key challenges of our customers sustainably and reliably, each of which is of high relevance in the growing international competition. Our focus is on the leading companies public organizations in the life sciences sector. This is the industry in which we are at home and in which we have sustainable success through the definition, implementation and introduction of forward-looking methods, strategies and solutions.


ACCURIDS provides a FAIR Data Registry software for collaborative implementation of enterprise data standards for unique identification. We believe that collaborative implementation of data standards and AI is the key to solve global challenges in patient safety, supply chain and R&D. Towards this goal, we initiated with 11 pharma companies and the Pistoia Alliance the collaborative creation of the open-source ontology for the ISO standards on Identification of Medicinal Products.

Join Us for the 5th Annual Quality Management Event with Boehringer Ingelheim - Sharing Insights and Experiences

We are thrilled to announce the upcoming milestone in our journey – the 5th Annual Quality Management Event which is held this year together with our valued host: Boehringer Ingelheim!


As a dedicated Life Sciences consulting company, we have always believed in the power of collaboration and the sharing of knowledge. This event serves as a platform for professionals like you to connect, exchange the latest insights from individual projects, and share invaluable experiences from the real-world usage of various quality management systems.

Event Highlights:
Date: Thursday, 19th of October 2023
Time: 08:45 AM – 04:15 PM (CET)
Location: Boehringer Ingelheim - Binger Straße 173 - 55216 Ingelheim am Rhein

Why Attend?
This event isn't just another conference – it's an opportunity to be part of a vibrant community that is committed to raising the bar for quality management. Here's what you can expect:

Uncover New Strategies: Discover cutting-edge strategies that are shaping the landscape of quality management. Our lineup of expert speakers will delve into key trends and innovative practices that drive results (e.g.: Practical use of AI, Just in Time Learning).

Project Insights: Gain firsthand insights into real-world projects from professionals who have successfully navigated challenges and achieved remarkable quality outcomes. Learn from their triumphs and lessons learned.

Networking Opportunities: Connect with like-minded peers, industry leaders, and potential collaborators. Our event fosters an environment where meaningful connections are made, opening doors to future partnerships.

Interactive Workshops: Engage in interactive workshops that allow you to apply newfound knowledge directly to your projects. Our hands-on sessions are designed to be practical and actionable.

Q&A Sessions: Get your burning questions answered by our panel of experts during dedicated Q&A sessions. Benefit from their deep expertise and varied perspectives.

How to Participate:
To be part of this transformative event, simply register via the following link Register Here for more information. Space is limited, so don't miss out on securing your spot!

Mark your calendars for Thursday, 19th of October 2023 and get ready to immerse yourself in an event that promises to inspire, educate, and empower. We look forward to welcoming you to our 5th Annual Quality Management Event at Boehringer Ingelheim!

Celebrating 10 Years of Excellence in Driving Digital Transformation Projects for the Pharmaceutical Industry!

We are delighted to announce that our company, specializing in digital transformation projects for the pharmaceutical industry, is reaching a remarkable milestone: our 10th anniversary! For the past decade, we have been dedicated to partnering with our clients to navigate the dynamic digital landscape and drive transformative change within the pharmaceutical sector.


Throughout the years, we have worked closely with numerous pharmaceutical companies, leveraging our expertise to implement cutting-edge technologies, optimize processes, and empower our clients to embrace the digital future. Our commitment to excellence and our deep understanding of the industry have enabled us to help our clients achieve remarkable results, streamline operations, and stay ahead of the curve.

As we reflect on our journey, we want to express our sincere gratitude to all our clients, partners, and employees who have played a pivotal role in our growth. Your trust, collaboration, and support have been the foundation of our success, and we are immensely grateful for the strong relationships we have built together.

Looking forward, we are excited about the future of digital transformation in the pharmaceutical industry. We remain dedicated to staying at the forefront of technological advancements, guiding our clients through the complexities of digital adoption, and unlocking new opportunities for growth and innovation.

To celebrate our 10th anniversary, we have planned a series of special events, thought leadership sessions, and client appreciation initiatives throughout the year. These activities will allow us to express our gratitude, share valuable insights, and continue fostering the strong bonds we have established with our valued clients and partners.

We want to take this opportunity to thank everyone who has been a part of our journey. We are very proud of the progress we have made together and excited about the possibilities that lie ahead. Here's to the next decade of driving digital transformation, achieving new milestones, and creating a digitally empowered pharmaceutical industry!

Stay tuned for updates on our anniversary celebrations, and we look forward to celebrating this momentous occasion with you.


MAIN5 and Userlane Partnership Announcement

We are thrilled to announce a new partnership between Userlane and MAIN5.


MAIN5 is a leading Management Consulting firm in Life Sciences focused on strategy, processes, and solution consulting in the regulated R&D – particularly in Regulatory Affairs, PV and Quality Management. The holistic approach, which places the primary focus on the route to the digital future and the involvement of people, is also used to implement complex visions and ideas for leading companies in the pharmaceutical industry.

MAIN5 strives to deliver comprehensive support to their customers, from vendor selection, implementation, to ongoing training and support for GxP relevant computerized systems. By partnering with Userlane, MAIN5 is expanding their capabilities in the realm of digital adoption and empowering their clients to navigate the complexities of digitization and cloud transformation. Userlane’s innovative platform brings them one step closer to their vision of revolutionizing traditional and laborious SOP and application training methods.

“We are excited to introduce meaningful and role-based ‘just in time training’, replacing inefficient practices and driving efficient knowledge transfer within organizations.  Furthermore, we recognize the immense value of Userlane beyond training alone. Its functionality extends to live systems, providing users with real-time assistance when they need it most. This valuable tool enhances user experience and ensures seamless productivity within the digital environment.”
Sabine Gölden – Principal Consultant, MAIN5

With Userlane, MAIN5 is poised to deliver enhanced solutions and support to their joint clients, reinforcing their commitment to excellence in the life sciences industry. Together, MAIN5 and Userlane embrace the current and future challenges of training and education in the pharmaceutical industry. We look forward to a successful partnership that will propel our clients towards greater success in an increasingly digital world!

European life sciences consulting leaders MAIN5 and fme AG offer first end-to-end, vendor-neutral business and tech change management service

The strategic alliance will address growing market demand as data-driven ambitions and M&A activity peak in the industry


The European Life Sciences Team of fme AG, the digital transformation IT services specialist, and European life sciences consulting leader MAIN5 have formed a strategic partnership in Europe to meet a growing gap they have identified in their market – for a vendor-independent digital transformation proposition geared specifically to the needs of life sciences companies.

The combined proposition will be the first end-to-end, vendor-neutral business and tech change management service for this market. fme Life Sciences Europe specialises in platform implementation, data integration and migration consulting services, while MAIN5 Management Consulting provides advisory services in the life sciences industry around organisational change, business process management (BPM) and project management.

The alliance will address soaring market demand as companies’ aspirations to become more data driven grow, and as merger and acquisition activity peaks in the life sciences industry, triggering ambitious system migrations. Together, MAIN5 and fme will help the pharma industry tackle transformation projects more holistically from both a business and technology standpoint, irrespective of the technology platforms adopted by the client.

The partnership, which was inspired by personal working relationships that go back for many years and is already delivering combined services to a major blue-chip pharma client, has been formed on an equal footing.

Ian Crone, Business Unit Director Life Sciences Europe at fme AG, said: “This move comes very much in response to the evolving needs of the market. We considered hiring our own people to build the same change management/project expertise, but bringing them all on board and up to speed with the particular needs of life sciences clients– for example around regulatory information management and impending IDMP requirements – would have taken too long. MAIN5 already had all of that specialist industry knowledge, expertise and experience, so a strategic partnership made perfect sense.”

Romuald Braun, Managing Partner at MAIN5, added: “Through this partnership, our two companies have broadened the scope of our offerings. MAIN5 provides expertise in the business aspects of change in life sciences, in the form of end-to-end business services/consulting and vendor-neutral systems validation. Meanwhile fme specialises in the technology – the migration and integration of data as part of consolidation or transformation initiatives. Combined, this makes for a very powerful proposition for life sciences, supporting our clients’ projects end to end with a comprehensive business and IT capability.”

One benefit of this is that life sciences companies will be better able to scope their data challenges and establish proofs of concept at an earlier stage in their process transformation initiatives.

fme AG’s Ian Crone noted: “So many companies are at risk if they haven’t assessed the quality and any problems with their data ahead of time. Now, we’ll be involved at a much earlier stage and be able to advise companies on an optimal approach. After all, there’s no value in investing in and going live with a new system if the data being moved across does not meet the quality requirements.”

Data-based transformation projects are reaching an all-time high in life sciences, as new regulatory requirements such as DADI and IDMP loom large. Merger and acquisition activity in the industry has intensified, too.

MAIN5’s Romuald Braun explained: “This triggers all kinds of process and system consolidation activity. Also, as companies look to manage more of their activities in the cloud, where they can take advantage of more agile and up-to-date system functionality, the diversity of technologies and the need to keep everything validated and in sync means there’s a lot to keep on top of.

“Through this partnership with fme, you’ll see us offer continuous validation and compliance in a standardised way, drawing on our business knowledge and fme AG’s technical capabilities – just one of the exciting outcomes of this already proven alliance.”


Learning management in the pharmaceutical industry

Higher product quality through professional training

In the strictly regulated pharmaceutical industry, product quality determines long-term success. It is estimated that quality assurance and the cost of remedying defects lies between 20 and 30% of the total cost. Up to a quarter of production staff in the pharmaceutical industry work in quality assurance and their numbers are on the rise. This has dramatic consequences for companies that are under increasing cost pressures. However, product quality can be significantly improved through professional e-learning that clearly conveys the knowledge employees need to perform routine activities properly and without error.
Language boundaries and fluctuating staffs are major challenges in meeting this task, especially for companies operating on a global basis.

The latest figures from the European Federation of Pharmaceutical Industries and Associations (EFPIA) show that more than five million people work in the pharmaceutical industry worldwide. The number of production-oriented jobs has increased by 22% in the past ten years. At locations producing sterile forms of pharmaceutical, 20 to 25% of these work in quality assurance; at plants making non-sterile forms, the figure is 10 to 15%.
In most cases, these employees are only being trained on the basis of standard operating procedure (SOP) documents.

Ideally, these documents serve two requirements:

  1. meet the regulatory requirements for audits

  2. clearly provide employees with the knowledge they need to perform their routine activities properly and error-free.

This poses a particular problem as the pressure from legal requirements continues to grow. Most SOP documents therefore meet the first requirement very well, using the verbiage used by the auditors, as revealed when 94 experts from the industry were interviewed for the MAIN5 study "Pharma Insights 2019." 70% of them believe that the SOPs of the pharmaceutical industry are so incomprehensible because of the way they have evolved without an eye to good, meaningful communication practices. 65% believe that they are primarily focused on audits. Only 8% of the respondents consider these processes and training to be future-oriented.
This confirms that the second requirement for SOP documents is mostly being neglected. Production staff will usually find it hard to find the relevant content at a glance. This comes at the expense of learning success. Formally, it appears that employees are well-trained, but their actual understanding of the content often falls by the wayside. This just results in pitfalls that they may very well fall into.

Quality defects lead to high costs
Since 2010, the number of drug recalls has almost doubled, according to figures from the Federal Institute for Drugs and Medical Devices (BfArM). At the same time, the amount spent on personnel to eliminate these defects has climbed to between 20 and 30% of the total costs.
Employees, especially those working in production, need access to a learning system that enables them to carry out all of their routine tasks reliably, correctly, and without errors.
Modern e-learning modules offer an excellent set of tools for this purpose. Once created, they will save additional staff costs, ensure consistent quality of the training content, allow individuals to learn at their own speed, and enable a deeper understanding of the content. Even with high employee turnover, they can be used at any time. At an advanced level, training outside of real production can be done using "virtual reality."
E-learning with a focus on a deeper understanding of the content is not a trivial challenge, however.

Learning with pleasure instead of red tape
The experience with current major projects shows that e-learning can be very successful, but also requires a lot of work.
In the age of YouTube, employees around the world have become accustomed to receiving instructions and training for all situations in a skillful and effective manner. They increasingly expect this same high standard on the job. For many of them, this may be the only way to reach them didactically. Providing clear, audiovisual demonstrations of learning content also overcomes many language barriers.
On the contrary, audit-focused learning content is text-based and just seems to be a lot of red tape.
For effective e-learning, it is not enough to ask existing specialists to pass on their knowledge. Rather, this information must be visually and audibly presented in an easily understandable and appealing form (learning from sense of duty is always less effective than enjoyable learning).
E-learning that follows best practices has proven to be a very successful form. It should be interactive, easy, and with individual modules of 20 to 40 minutes duration. The special software required to create these formats should be selected according to customer requirements. Templates are thus developed that provide a basic framework for the content and motivate learners in an appealing way. These templates also make it easier to quickly create additional training sessions without the need for special IT skills.
The time gained can then be meaningfully used for the didactic processing of the content. In the future, the topic of training through e-learning will require more management attention and sufficient financial support from the company.

Choosing the right target group
With the introduction of effective e-learning, one must also correctly identify the target group. This must meet the regulatory requirements, but must not go too far. On the one hand, training for employees who cannot do anything with the content in their day-to-day work is not only useless, but will cause general training fatigue and unnecessary costs when they are kept from doing their regular jobs. On the other hand, if too few employees are trained, this can lead to compliance problems.
It is often not possible to determine the target groups only on the basis of employee job descriptions, because, in most cases, they are only a static representation of the organizational structure. It is different when companies describe their processes in the form of processes, process roles, and responsibilities. Because processes reflect the day-to-day work of companies, they can make it easier to identify who ought to have what training.
Effective e-learning for the right target groups not only can significantly improve product quality in the medium term, it can also be a positive experience for employees – all in the company's own interest.

IDMP:Consolidated standards require comprehensive digitalization strategies

Regulation as an opportunity for digital transformation and process harmonization

Frankfurt, March 4, 2020The future is digital – this cross-sector process also includes the regulated processes of the pharmaceutical industry. In the future, a large number of structured data will have to be submitted to the authorities to enable cross-border identification of medicinal products (IDMP – Identification of Medicinal Products) on the European market. After years of preparation, the final implementation guideline has now been published (February 11, 2020, version 1) and increases pressure on the industry: "While a certain waiting period during the implementation was still in effect, the time runs from the publication of the implementation guideline version 2 (planned for autumn 2020) for ISO iteration 1. "The companies then have 24 months to implement a complex software and process project," says Karsten Krüger, Managing Partner of the pharmaceutical consultancy MAIN5. Companies then urgently need a viable solution for a regulatory information management system (RIMS) that manages drug data and facilitates harmonization. So far, even in pharmaceutical companies, various databases between the individual national and subsidiary companies have hardly been on a common standard.

Digitalization and big data
The move towards new systems makes sense in two respects. Harmonizing the data stocks and bringing them to a common standard helps companies to achieve leaner data and process structures. While the core idea behind the IDMP is in-depth knowledge of the medicinal products on the market with a special focus on their composition and their pharmacovigilance, a 360-degree view of the entire system and process landscape offers the potential for savings and more safety for patients and users. Medicines can be compared and active ingredients can be traced back to the manufacturer quickly. This can prevent harm to a patient in an emergency. “In the coming years, competition will be even tougher, and technologies such as artificial intelligence and big data will determine competitive advantages. Anyone now investing in a viable digitalization strategy is not only implementing current regulatory requirements, but also facilitating internal processes and improving the contribution margin,” says Karsten Krüger from MAIN5 about the upcoming changes.

Five ISO standards consolidated
For the implementation of the IDMP initiative, the EU is consolidating five ISO standards; a further worldwide expansion is conceivable. Pharmaceutical companies face the challenge of managing the growing number of structured data and using it profitably for the optimization of processes in the company. At the same time, processes for health insurance companies and – above all – patients also benefit. “With the IDMP, for the first time there is a comprehensive comparison of medications, dosages and active substances. This has savings potential for the cash system, and at the same time every patient receives more transparency than ever before,” says Karsten Krüger. Companies that invest in a comprehensive and sustainable structure will secure the greatest advantage.

About MAIN5 ( was established in 2013 as a Management Consulting firm and focuses on strategy, process and solution consulting with international life science companies in the regulated R&D and Regulatory Affairs and Quality Management sectors. The consultants at Main5 combine their methodical and systematic approach with years of experience in the industry. The holistic approach, which places the primary focus of the route to the digital future on people, is also used to implement complex ideas from leading industry customers.

Further information: MAIN5 GmbH & Co. KGaA, Administrative Headquarters: Schumannstr. 27, 60325 Frankfurt am Main, Germany Tel.: +49 (0) 69 505 027 228, email:, Web:

PR Agency: euromarcom public relations GmbH, Tel.: 0611 / 973150, email:

Efficient practice management: Humans first

Process optimization is an industry term. Nevertheless, a dialysis practice from Zwickau took bold steps to analyze and optimize its processes. The results were astonishing – overstaffing was causing friction and a number of other processes were sub-optim

The Zwickau Nephrology Center was founded in 1993 as an internal medicine clinic, including a dialysis center with 17 dialysis stations. Today, over 200 hemodialysis patients are being treated at 55 dialysis stations and there are three additional dialysis stations for patients with hepatitis. The practice is run by nephrologists Dipl.-Med. Heike Martin, Chair of the Association of German Kidney Centers (Verband Deutscher Nierenzentren e.V.), Grit Müller, Dr. Alexander Sämann and Sebastian Höhne. Patients are looked after by nurses and another internal medicine specialist. The practice employs a total of 60 staff members in its two clinics.

Imperfect processes
The routine work of a dialysis clinic runs like clockwork, with patients changing over according to a certain rhythm. Current statistics show that throughout Germany one dialysis nurse looks after six or seven patients, whereas in the Zwickau center the nurse-to-patient ratio was around one third below the existing norms. In spite of that fact, the staff members felt overworked, which caused recurring dissatisfaction. Under these circumstances, Heike Martin took a bold innovative step of bringing into play an external consultant - namely, MAIN5 - a consulting company with a focus on health economy and pharmaceutical industry. It carried out a preliminary analysis and, more importantly, spent two days in the practice. "We spent two days in the practice with the team and analyzed the personnel situation, processes and technologies. Besides data collection, we prepared outlines of the practice and included in the final analysis the overarching processes that do not take place every day. The key factor for us was getting an accurate view of the value streams in the day-to-day operations of the practice“, explains Dr. Adam Sobanski from MAIN5. Each dialysis lasts between four and five hours and is carried out in two or three shifts. At midday, not only is there a changeover of patients, but also a change of nursing shift, which means that for a short period of time the staff is doubled. "The main focus of our performance improvement plan was to involve our staff members in the analysis and consulting process rather than simply ambushing them with new processes“, says Dipl.-Med. Heike Martin. A workshop at the start of the collaboration ensured a high degree of acceptance among the staff members and their involvement in the process. For MAIN5, this concept is the only correct approach – as process optimization seldom works without getting people on board from the start.

40 percent overlap of staff
During the analysis, it became clear that a temporary overlap of personnel was causing problems in the process. "The fixed clocking on and off of patients and personnel meant that at shift handover there could be more than 40 percent overlap of staff, which resulted in the direct opposite of the desired effect: instead of working faster and more efficiently, the staff members began taking the work out of the hands of their colleagues“, says Dr. Adam Sobanski from MAIN5. In addition, some processes were extremely time-consuming – including changing the filters of the dialysis machines. The wide range of dialyzers in use put the staff members under a lot of organizational pressure, which was reduced by standardization while maintaining the same quality. Both stock keeping and ordering were also significantly simplified due to this change. Another bottleneck - the monthly laboratory testing of blood values - was also resolved by the comprehensive consulting and analysis processes. Blood samples used to be collected monthly on two fixed days, packaged and sent to a specialist laboratory. The resulting stress was considerable. Another stressful situation occurred when the values were communicated back from the laboratory and had to be transferred to the patient data sets. Instead of this block processing, blood samples are now being sent off as part of the daily workflow throughout the month, eliminating such peak load periods.

Better distribution of staff
The solution to the personnel situation required new service plans as well as further extensive workshops aimed at getting the staff members in the practice involved here too. The goal for the management was not to reduce the overall number of employees, but to redistribute the staffing and, therefore, to tap into previously unused potential. "We can do even more for our patients and that was our aim: to fill the resulting free time with other activities that offer our patients direct added value“, says Dipl.-Med. Heike Martin. These include BIA measurements to test body composition and other valuable services. In fact, the results of the analysis also brought a palpable sense of relief and understanding among the staff members - there were no other serious reasons for lack of efficiency than the unfavorable staff distribution. As well as the service plans, the changeover times of patients were also adjusted. Previously, the changeover was scheduled during the lunchtime within a 30-minute window – which rarely worked. First, most patients were fetched and carried by transport services such as the Red Cross or the Workers' Samaritan Federation (Arbeiter-Samariter Bund); secondly, for some patients it takes longer to get back on their feet after dialysis treatment. By extending that time window to 70 minutes, not only was the traffic congestion outside the practice reduced, but also the staff members could allow their patients to stay at the medical center longer and take their time to recover after dialysis treatment.

New processes for the practice
Unlike the pharmaceutical industry projects, in this case the focus was not on a new system landscape with document management or pharmaceutical audits, but on the direct process optimization between practice personnel and patients. "This is unusual in the project business. However, it is an obvious example of how significant the optimization potential can be within a practice. Besides the beneficial change of the staff situation, we also reached a remarkable business performance improvement. And this successful experience can be transferred to other practices and medical disciplines“, explains Dr. Adam Sobanski, partner of MAIN5 and directly responsible for the project.

12. Official GAMP® 5 Conference: Data Integrity in the World of Pharma 4.0

Business processes between digital transformation and regulation

Frankfurt/Mannheim, December 5, 2019The pharmaceutical industry is in a state of tension: Business processes need to be digitized, but industry is subject to GxP regulations. These regulations are designed to ensure patient safety, product quality and data integrity. As a result, many industry trends, such as production and business processes, can only be implemented with additions or limitations.The pharmaceutical experts from MAIN5, a leading consulting company in the industry, also participated in the 12th GAMP® 5 conference in Mannheim. "With increasing pressure, the pharmaceutical industry faces great changes due to the ongoing digitalization and can only make economic gains by accepting these challenges actively. However, the regulated environment must always be considered, what influences the selection of products and suppliers as well as the legally compliant implementation of Pharma 4.0 projects," says Alexander Tryba, MAIN5 partner

Data integrity in Big Data
A paradigm shift in the industry must also take place, as a study by MAIN5 revealed in the summer: according to "Pharma Insights 2019", 65 percent of pharmaceutical processes are focused only on the next audit. 70 percent of the surveyed industry experts also see the history as a source of process, but not modern and lean models. Another topic in Mannheim during the two conference days is the structured collection and legally compliant use of data and information – or "big data". 64 percent of those surveyed assume that no more than half of the data generated will be analyzed in order to optimize future processes. "When it comes to gathering information and analyzing data, as well as all digitized processes, there are three main pillars that must fit: product quality, patient safety, and data integrity," says pharmaceutical consultant Tryba.

Bridging the gap between compliance and quality
Overall, the value creation processes in the process industry offer enormous potential and can only benefit from general digitalization.Therefore, many old systems have to be replaced and new data models have to be created, the MAIN5 experts agree. Meanwhile, the replacement of paper processes and full integration into systems is a crucial component. "Useful information must be extracted from documents, and a harmonized and system-wide data model must be created for the companies. This means that specialist departments, quality management and IT work together on processes in the pharmaceutical companies. Likewise, a comprehensive safety management must be created. However, the pharmaceutical industry also has the opportunity, due to its many years of experience with regulations, to become one of the flagship international industries in terms of security and digitization," explains Alexander Tryba of MAIN5.

About MAIN5 (
MAIN5 was established in 2013 as a Management Consulting firm and focuses on strategy, process and solution consulting with international life science companies in the regulated R&D and Regulatory Affairs and Quality Management sectors. The consultants at Main5 combine their methodical and systematic approach with years of experience in the industry. The holistic approach, which places the primary focus of the route to the digital future on people, is also used to implement complex ideas from leading industry customers.

Further information: MAIN5 GmbH & Co. KGaA, Administrative Headquarters: Schumannstr. 27, 60325 Frankfurt am Main, Germany Tel.: +49 (0) 69 505 027 228, email:, Web:

PR Agency: euromarcom public relations GmbH, Tel.: 0611 / 973150, email:

Pharmaceutical industry: Training deficiencies are causing increasing losses

Professional e-learning makes it easier for employees to handle complicated SOP documents

Frankfurt, November 21, 2019In the strictly regulated pharmaceutical industry, product quality is decisive. Almost a quarter of the production staff in the pharmaceutical industry works in quality assurance – the trend is rising. It is estimated that spending on these personnel and remedying quality defects is between 20 and 30 percent of the total cost. Since 2010, the number of drug recalls has almost doubled, according to figures from the Federal Institute for Drugs and Medical Devices (BfArM). So problems exist in the application of quality assurance systems.

"We find that SOP documentation is almost entirely tailored to audits. For the employee, however, their contents are usually too complicated and are hardly suitable for training," says Dr. Adam Sobanski, MAIN5 partner. The consulting firm specializes in complex A-Z projects in the pharmaceutical industry and advises companies on the path to more effective employee training. "Ideally, an employee should understand what an SOP is about when they first read it," says Sobanski. "Employees, especially those in production, need to understand how to carry out routine activities correctly and without errors."

Modern e-learning modules offer an excellent set of tools: Once created, they save additional staff costs, ensure consistent quality of the training content, enable individual learning speed and can be used at any time, even in the event of high employee turnover. At an advanced level, training outside of real production can be done in "virtual reality".

Study confirms audit focus
The industry is generally very focused on audits, according to the MAIN5 study "Pharma Insights 2019": 94 experts from the pharmaceutical industry were interviewed. 70 percent of them believe that the SOPs of the pharmaceutical industry are so incomprehensible because historically they have grown. 65 percent believe they are primarily focused on audits. Only eight percent of respondents consider these processes and training to be future-oriented. Here is where the biggest challenge lies. "The experience of the current major projects with our customers shows that e-learning is very successful, but also requires a lot of effort," says Sobanski.

Enjoyable learning is most effective
For effective e-learning, it is not enough to ask existing specialists to pass on their knowledge. Rather, this information must be visually and audibly presented in an easily understandable and appealing form (learning from sense of duty is always less effective than enjoyable learning). Best practice e-learning should be interactive, easy and with individual modules of 20 to 40 minutes duration. For their creation, special software is required which is selected according to customer requirements. Templates are thus developed that provide a basic framework for the content and motivate learners in an appealing way. These templates also make it easier to quickly create additional training sessions without the need for special IT skills.
The time gained can be meaningfully used for the didactic processing of the content.

Therefore, e-learning can form the basis of a higher quality culture in the company, help to avoid mistakes in routine processes and also contribute to better identification by employees with their line of work. Within the company, the training topic will require more management attention and a financial foundation in the future.

About MAIN5 ( was established in 2013 as a Management Consulting firm and focuses on strategy, process and solution consulting with international life science companies in the regulated R&D and Regulatory Affairs and Quality Management sectors. The consultants at Main5 combine their methodical and systematic approach with years of experience in the industry. The holistic approach, which places the primary focus of the route to the digital future on people, is also used to implement complex ideas from leading industry customers.

Further information: MAIN5 GmbH & Co. KGaA, Administrative Headquarters: Schumannstr. 27, 60325 Frankfurt am Main, Germany Tel.: +49 (0) 69 505 027 228, email:, Web:

PR Agency: euromarcom public relations GmbH, Tel.: 0611 / 973150, email:

MAIN5 and Iperion announce partnership to reorganize master data management

Combining the strengths of MAIN5 and Iperion Life Sciences Consultancy for the benefit of the European Pharmaceutical Industry.

Frankfurt and Vlijmen, August 23, 2019 - MAIN5 and Iperion Life Science Consultancy entered into a strategic alliance to better serve customers within the field of implementation of Regulatory Information Systems, data management, project management and change management.

“As the pharmaceutical industry faces organizational, technical and coordination challenges in an ever faster changing regulatory environment, the combined expertise of our companies will allow our customers access to top expertise with optimal communication possibilities,” Gero Neidlinger, partner of MAIN5 and Frits Stulp, managing director of Iperion Life Sciences Consultancy explain.

„Implementation of new regulatory guidance and new systems requires effective change and project management involving all stakeholders. The real change in our industry can only be made by understanding the roles of both regulator as well as industry side (including marketing authorization applicant, holder, and clinical research sponsor) and addressing the needs of the process. By combining the power of interoperable data with compatible processes, a real benefit can be achieved for the patient, and this is where our joint ambitions lie," says Frits Stulp. In addition, as IDMP data is cross-functional in various business areas and often distributed across different IT systems and even third parties, immense effort is required to identify and consolidate all IDMP-relevant information with most customers," Gero Neidlinger adds.

IDMP requires sustainable master data management and intelligent networking of product information, IT systems and processes. The objective is a 360-degree all-round view of the product data with homogeneous terminology and structure that will pay off doubly in the course of digitization. Both consulting companies are specialists in the digital transformation of the pharmaceutical industry, which is under heavy regulatory pressure.

The implementation of the ISO IDMP is phased in the areas Substance, Product, Organization and Referential Data (SPOR). Based on standardized data, a reliable exchange of drug information will be made possible and global interoperability ensured. There are several questions to answer in the respective pharmaceutical companies: Who in the company cares for which data, when, and how? In addition, IDMP stands in the future between previously independent software solutions of the various business units and requires common interfaces. "The decisive factor is a strategically oriented roadmap for sustainable implementation in the affected business units. Only then can synergy effects be used,” conclude Frits and Gero.

Pharma study: How mature processes only last until the next audit

Big Data falls short - the consulting company MAIN5 presents study "Pharma Insights 2019"

Frankfurt, July 17, 2019 - Hardly any industry is dragged down so much by regulation in innovation work as the pharmaceutical industry. This was the key result of the "Pharma Insights 2019" study, which the consulting firm MAIN5 recently published. 65 percent of the processes in pharmaceutical companies are audit-focused, and the majority (70 percent) have grown organically over time. Only 8 percent of the processes are future-oriented, according to a survey of 94 specialists and executives from the pharmaceutical industry. "The pharmaceutical industry could tap much more potential, which often arises from necessity. As companies operate from audit to audit, the focus is progressively shifted away from competitiveness", says Tore Bergsteiner, Managing Director of MAIN5. Industry experts advise pharmaceutical companies on how to digitize regulated processes. So far, however, only part of the accumulated data from different business units are being analyzed and used for innovation and future optimization.

Big Data: Running at half power
64 percent of those surveyed assume that no more than half of data generated will be analyzed and future processes optimized. 26 percent of the interviewed professionals were reluctant to answer the Big Data question: "The uncertainty surrounding Big Data is huge. However, high-quality inventory data is the most valuable resource today when it comes to new innovations and process optimization", states Tore Bergsteiner of MAIN5. Still, the pharmaceutical industry is feeling the pressure, which is further confirmed by declining sales of blockbuster drugs: 47 percent of the study respondents state that the development of new growth markets and product diversification are just as important challenges. After that, respondents mentioned the protection of sensitive patient data with the fulfillment of GDPR (45 percent), and in third place, business risks due to expiring patent protection and thus generics in the market (44 percent - multiple answers were possible). Falling blockbuster sales also appear among the 2019 challenges at 41 percent.

Digitization: Hardly a risk
Respondents agree on the risk assessment of growing digitization in the patent- and knowledge-driven pharmaceutical industry: only 21 percent see a risk, but 70 percent agree this is exceedingly small or simply non-existent. "The depth of digitization will determine the distribution of market share in international competition and also with which active ingredients and drug combinations new products can be brought to the market," explains the MAIN5 Managing Director. With numerous mandates from the world's largest pharmaceutical companies, the MAIN5 team regularly reorganizes complete processes, structures and systems. The goal is to develop robust, efficiency-based process relationships and the sustainable, competitive positioning of a manufacturer or distributor in the global market of pharmaceutical companies.

Change Management: When the second heart attack threatens

Only one in seven infarct patients is successfully managing Change

Frankfurt, April 10, 2019 - Change management is not a wizardry: there's an urgent problem, a vision of the future without the problem, and thus a way to improve the situation. "According to medical studies, what seems so obvious has no effect at all on heart attack patients," says Dr. Adam Sobanski, one of the partners of Main5, a consulting company focused on the life science industry. In fact, only one in seven patients that suffer a heart attack manages to change their lives in a truly sustainable way. And that's the case, although the pain as well as the solution are logical and transparent. "If we take this as an example of change management in the worlds of pharmaceuticals and life sciences, the industry is quite modest," warns Dr. Sobanski. While some managers only grin tiredly when the subject comes up, large companies have long been active and have projects implemented by specialist consultants such as MAIN5 in order to position themselves for the future.


Agile Change Management
With changes in the strict process chains of the life science industry, it is a bit like with modern IT projects in general: "We first look at companies holistically and provide agile change management, which is mainly implemented iteratively. The solution can only ever be individual, because with every iteration, the conditions change again," says Adam Sobanski. For him, the secret lies in targeted impulses that are established externally and that combine both personnel and leadership in one company. "Without acceptance in all groups, the step from change to fail is very small," says MAIN5 partner Sobanski. By the way, change management is not about deliberately throwing proven and flawlessly functional processes and structures overboard - yet examples also illustrate the energy involved in disruptive change processes.


iPhone: Not a need, but a success
A striking example is the iPhone, with which Apple caused a stir in 2007. "There was neither pressure nor a need for a touch-based device - but an impetus triggered by the viable and thought-out concept that completely changed the mobile phone market. That's how change management can work, contrary to the occasional naivety of managers," explains Sobanski from MAIN5. Change stands for frankness and openness and above all for a corporate culture that moves with the times. "In an industry whose competitive environment is becoming increasingly fierce, stagnation will quickly lead to a second heart attack - something that must be prevented," warns Dr. Adam Sobanski.

Higher productivity, lower costs: The pharma industry meets for the DIA 2019

MAIN5 expert panel: Launch medications faster and at lower cost despite stricter formalities

The pharma industry is still facing increasing pressure. The age of blockbuster medication is over, while regulatory stipulations are becoming stricter. The annual conference of the DIA (Drug Information Association) is being held in Vienna from February 5 to February 7. The MAIN5 pharma expert panel (Stand B31) is focusing on processes and systems in research and development: "The market for pharmaceutical products is demanding faster development cycles at lower cost under increasingly strict international regulatory stipulations. As a result, the entire industry continues facing pressure to demonstrate productive and result-oriented work based on lower fixed costs," says Tore Bergsteiner, Partner of the consultancy firm MAIN5 which specializes in pharma companies.


Always aspiring for process excellence
Effectiveness, above all in research development, is increasingly under the microscope according to the team at MAIN5. "Value creation and a culture of performance in the R&D sector is being continually updated in a lot of businesses in order to guarantee that pharma companies are future-ready," says Tore Bergsteiner. However, successful research is not enough for overall success: By aspiring for "process excellence", and looking to optimize and modify existing structures, it is possible to create new impulses and energies that have not yet been utilized. "It's getting tight in the pharma industry thanks to digitalization and other innovations in healthcare. New job profiles are appearing, such as Data Scientists. Anyone who is not currently adapting their internal structures and ways of thinking will miss the exit before they know it," warns Dr. Adam Sobanski, Partner at MAIN5.


Therapy for people is the goal
The growth in regulatory requirements across all sectors is ensuring that intellectual riches are being represented in databases and documents. A focus on systems and processes for regulated data and document management in clinical development, approvals and more, is consistently contributing to compliance, efficiency and productivity. "In fact, an integrated data and document management system that will generate long-term value is already deciding the success or failure of new innovative developments in therapy. With solutions such as lab data management, clinical data management, and holistic document management, companies will enjoy significant benefits long-term," explains Bergsteiner.


New technologies on the road to success
There are plenty of opportunities for the pharma industry to make day-to-day business more efficient within the high-speed world of artificial intelligence development: The countless possibilities for digitalization range from more efficient lab work to the development and approval of effective therapies. Mental work automated using artificial intelligence is already speeding up and improving research, development and approval work. MAIN5 works as an adviser to leading technology providers with proven success.

Everything is in Flux

The Secret of Successful Change Management

Frankfurt, January 1st, 2019A company is a complex system of close collaboration and interaction of people and ideas, connected by and dependent on various social, economic and financial factors. A system that, like a mobile device, depends on many conditions which influence each other and is constantly changing. To successfully lead such a live organism into the future means, above all, understanding the people who support the system and from which the system originated. Involving them in the evolutionary company processes is the secret of successful management. The drastic process of changing a corporate structure must always be mastered by it first: new structures change familiar processes, developments must be processed structurally and anchored in the psyche and corporate workflow. For a company to be able to live the flexible change, the first step is to let go of the illusion of being able to change a complex company structure based on a defined workflow. Probably the biggest challenge in adapting corporate structures lies in the fact that the company itself is in a continuous process of change. Companies develop through a changing workforce, adaptive customer structures or, for example, through market developments. Companies that want to be successful have to understand, as a first step, that continual change within a company cannot be stopped, but instead that its flowing dynamics should be used for progress.
The heart of change beats in the employee. Companies must therefore ensure that they can find and take their place in the new environment. Proper change management is therefore a smooth organizational development in which people in the company are actively involved in the change process.

Thinking in Systems
The complexity of a company structure knows few limits. After all, corporate systems are not spatially limited and do not only affect single individuals. On the contrary: every factor that makes up a company influences another factor. There can be no isolated solutions to further develop a system. The company as a whole must be seen and processed as a system.
People determine the high degree of complex dependencies within a company. Therefore, a company structure can only be developed and directed if people are ready to be led. However, that makes things complicated, because people live their own, unpredictable dynamics with which companies have to become engaged.

The Systemic Portrait
In order to grasp the dynamics, the systemic portrait first shows the status quo of the company system. It makes sense to create this portrait, for example, prior to a project to identify any possible obstacles in advance. To generate it, companies need to find answers to questions such as: what goals should be achieved through a targeted project. It is also fascinating to get an overview of which developments groups or people are interested in and how they relate to the planned project.
A systemic portrait works out the future challenges for a company as clearly as possible and also generally offers the possibility to better anchor people and individuals who want to be understood as part of the entire system in the organization. Notably, such a portrait shows not only positive developments.
It also shows where possible challenges may lie. For this reason, opposition to the project is interesting, as is the nature of the concerns that are raised.

Useful Tool: Opposition
At first glance, the term opposition is negative, but counterpoints are vital for companies. After all, a system can only change when it encounters opposition. It occurs automatically when familiar structures and processes change: many people quickly feel ignored; management may not be sufficiently involved in structural changes or may not support the changes; new skills need to be acquired; there is poor communication between the departments and IT... Fears for livelihood quickly arise.
Companies have to accept that opposition is emotional in many cases. It must be acknowledged in order to provide room for further development. Joint agreements that come about through dialogue and communication are much more successful than working against them all the time.

Communication in Systemic Organization Management
This dialogue is crucial for the success of a change management process, because communication is the most important area of change. There are various ways for companies to enter into dialogue with their employees. A positive example is to inform employees about developments using various roll-outs: for example, let employees follow the current state of development in the cafeteria; inform them about internal media. The most important task of internal communication is to keep employees informed; because the less they know, the more they will suspect.

The Principle of Systemic Questions
Systemic management also emphasizes the necessity and great significance of communication. Various techniques are available that enable company management to break new ground.
Circular questions or the principle of multiple points of view is a questioning technique that illuminates a problem from the perspective of third parties. The pharmaceutical company should ask themselves what the customer expects and put themselves in the situation of the "other" side. The change of perspective can create new thinking and even allow for new thought patterns.
Other systemic questions are the positive connotation (what might be the good thing about not having an assignment?) Or the paradoxical intervention that provokes and offers the opposite of a possible solution (what other options do you see to prevent a solution to this problem?).
It is often the only means when opposition to change seems insurmountable.

WorkCafé: Bringing Employees to the Table
The so-called WorkCafé approach fosters reciprocal communication for and with the employee. The session's message: There are good reasons for the change. Why are we doing what we are doing? The WorkCafé is planned in the so-called founding board. For this purpose, various project teams are formed within a company, which work on different areas that are important for the company's further development. The results are presented to the employees in the WorkCafé: questions can be asked and suggestions can be included. In this way, facts come to the table and are addressed openly and worked out together. The WorkCafé is an example of how reflection and dialogue can be established in the corporate culture and make it possible to deal constructively with opposition, to take systemic perspectives and to coach and qualify managers and multipliers for successful, collaborative change management.

Dr. Adam Sobanski
MAIN5 GmbH & Co KGaA

About: Dr. Adam Sobanski, who has a doctorate in chemistry with over ten years of industrial experience, knows both worlds: that of a consultant and of a consultant manager - and, therefore, he can offer solutions that work in the real corporate world.

About MAIN5 (
MAIN5 was established in 2013 as a Management Consulting firm and focuses on strategy, process and solution consulting with international life science companies in the regulated R&D and Regulatory Affairs and Quality Management sectors. The consultants at Main5 combine their methodical and systematic approach with years of experience in the industry. The holistic approach, which places the primary focus of the route to the digital future on people, is also used to implement complex ideas from leading industry customers.

Further information: MAIN5 GmbH & Co. KGaA, Administrative Headquarters: Schumannstr. 27, 60325 Frankfurt am Main, Germany Tel.: +49 (0) 69 505 027 228, email:, Web:

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