About the publisher of CliNFo
45 years of GKM Gesellschaft für Therapieforschung mbH:
A full-service contract research organisation reflected in global and national health policy
By Renate E. Hippe
1981: Founding and first steps
On 30 April 1981, Siegfried K. Hippe founded GKM Marketing durch Kommunikation GmbH, focusing initially on medical marketing. Equipped with extensive expertise gained in a research laboratory and a leadership position within major pharmaceutical companies, his vision was to establish a company that would provide long-term job security and foster a family-like collaborative environment. The company was founded with modest resources. The share capital was raised by selling the family’s second car, and the first office was located in the basement of a single-family home. The team consisted of the managing director and one assistant. Two years later, Renate E. Hippe, the founder’s wife, joined the company and assumed responsibility for finance and human resources. Her experience as a former marketing director at a research institute proved highly valuable to the growing business. Initially, the primary focus was the development of marketing strategies for medicinal products.
The World Health Organization (WHO) adopted the “Global Strategy for Health for All by the Year 2000.” In Germany, health politicians were engaged in intense debates about rising healthcare costs, efficiency, and healthcare reforms.
1986: Expansion of the service portfolio
GKM shifted its focus from medical marketing to clinical research and was commissioned to provide project and data management for clinical trials and post-marketing studies. As the demand for medical expertise grew, the team was expanded. Renate E. Hippe was appointed as the second Managing Director. Investments in electronic data processing for capturing study data in database systems marked the beginning of ongoing technological development.
In 1986 the world was shaken by the Chernobyl reactor disaster, leading to increased preventive measures. AIDS also became a health policy challenge and required intensive research into pharmaceutical solutions.
1991: Renaming and expansion
GKM was renamed GKM Gesellschaft für Therapieforschung mbH and evolved into a full-service clinical research organization (CRO). With the establishment of the Biostatistics Department by Dr. Dieter Schremmer, the company expanded its service offering to include biostatistical analyses of study data from Phases II and IV. The scope of studies now extended to the most important European countries. All organisational units of the company worked in accordance with Good Clinical Practice (GCP) guidelines.
The 5th amendment to the German Medicinal Products Act (German: 5. AMG-Novelle) imposed increased requirements for drug safety and led to a backlog of investment in the industry. During this period, health policy focused on implementing the German reunification, including transferring the West German healthcare system to the new federal states.
1996: Growth phase and new challenges
Despite challenging conditions in the healthcare system, GKM continued to prosper. The company planned to expand its service portfolio to include the evaluation of medical devices. Departments for Quality Assurance and Pharmacovigilance were established.
The Health Care Structure Act (German: Gesundheitsstrukturgesetz) and the introduction of long-term care insurance (German: Soziale Pflegeversicherung) shaped national health reforms. Clinical research increasingly focused on quality, efficacy, and the cost-effectiveness of medical services.
2001: Digitalisation and relocation
The rapid pace of digitalization created significant challenges at GKM’s original location. The facilities were not designed for networking or for the number of workstations required. In 2002, the company finally moved to its current location at Lessingstraße 14, near Ludwig-Maximilians-Universität of Munich. The basis for digitalising processes was laid.
The WHO focused on combating HIV/AIDS and malaria. EU Directive 2001/20/EC made Good Clinical Practice (GCP) mandatory for clinical trials in Europe.
2006: Internationalisation and expansion
The company expanded its service offering to include international clinical trials and medical devices. This growth required an extensive adjustment process to meet intercultural requirements and country-specific regulations. Regional partners operating worldwide were sought to provide study monitoring and quality assurance and were integrated into the company’s portfolio of services.
In Germany, a modernisation act was implemented to improve the safety of medicinal products. The WHO’s primary concern was combating infectious diseases.
2011: Personnel and structural adjustments
GKM continued to expand and eventually occupied all five floors of the Lessingstraße site. The international focus strengthened and the team grew to 46 employees. The growing organisational structure also required a strengthening of management. In 2014, the long-standing Head of Data Management, Dr. Karin Dürrstein, was appointed as an additional Managing Director.
In Germany, the Arzneimittelneuordnungsgesetz (AMNOG) came into force. The early benefit assessment of new medicinal products by the Federal Joint Committee (G-BA) became mandatory. Tough negotiations began between health insurance providers and the pharmaceutical industry to achieve greater transparency and cost control. The era of discounts began, and generics became increasingly important.
2016: New requirements and rising demand
The introduction of benefit assessment by the Federal Ministry of Health led to new challenges. A team was formed from the Biostatistics and Medical departments to conduct analyses and prepare AMNOG dossiers, following the concept specified by the G-BA. Demand for AMNOG-related services increased. Due to stricter regulations and growing cost pressure, pharmaceutical companies were increasingly compelled to outsource research services. GKM continued to grow and joined the German Federal Association of Contract Research Organisations (BVMA) in 2017.
The WHO was dealing with the aftermath of the Ebola crisis and sought to strengthen international early warning systems and emergency mechanisms. Beginning in 2015, the Sustainable Development Goals were introduced to reinforce global environmental, social, and development policies.
2021: Generational change and international crises
The COVID-19 pandemic presented enormous challenges for the global economy. GKM implemented comprehensive safety precautions and remote working arrangements to adapt to the new circumstances. Despite an initial decline, the order situation remained stable. GKM also participated in projects to combat COVID-19. Following the company founders’ retirement in early 2018, management passed to Dr. Karin Dürrstein, Rupert Lang, and Sonja Graß, daughter of the founding couple. GKM entered its second generation.
In a world marked by the COVID-19 pandemic, major inequalities in access to vaccines persisted. In Germany, health policy was in crisis mode. On 5 May 2023, the WHO declared the global emergency over. In February 2022, another event with far-reaching implications for the future shook the world’s population: the Russian Federation began its war against Ukraine, with consequences that remain unforeseeable to this day.
2026: 45 years of GKM and outlook
Despite global challenges, including numerous health policy and geopolitical conflicts, the company remains a stable and healthy company, providing around 100 employees a secure future. The founders’ original vision to build a company that provides long-term job security while fostering a cooperative and family-oriented culture – has been achieved. GKM remains committed to this path and has excellent prospects for future success.
