You need a good Founders team to rely on
When we, the three shareholders, met more than 10 years ago, we easily agreed on the structure and the goal of our company, but it turned also out that we had a common view to organically grow the company. Together we developed all the necessary contracts, processes and documents needed, combining our knowledge and expertise in clinical research, legal contracts and our former experience as entrepreneurs in different areas. Our regular shareholder calls are a good mix of strategic developments, financial and operational reviews and still lots of fun.
Even if you know how important your service is, the potential customer might not
For us, the idea to offer legal representation in Europe was a consequence of our joint experience being involved in global clinical trials for several decades. However, it turned out that the fact of mandatory legal representation is needed by regulations for non-EU/EEA companies without a subsidiary in EU/EEA was well known to us but not to our clients to the same extent. Through developing close cooperation with international active CROs (Contract Research Organisations) and regular conference participation in these non-EU countries, we could spread the knowledge.
Always try to optimize your workflow and your service
Legal representation is a high-risk business and you have to always be prepared for the unknown of what could happen in your assigned clinical trial or in any other legal representation activity. Only experienced Project Managers are assigned to our projects to oversee the activities and to implement early warning systems. With changing regulations and requirements, the understanding of the implications those might have on the activities is key to supporting our clients.
The first years after the company’s inauguration are limited when it comes to financial and human resources. As with the majority of entrepreneurs, we were also faced with the situation of never having the feeling an end to a working day as there were always to-do´s waiting on our desk.
Never stop learning
We are acting in a business environment which needs adjustment and flexibility to changing requirements, regulations and unpredictable challenges as we had during the Pandemic while setting up our second company.
The learnings we have made during these years of existence are many. But most important is having a good team, which can inspire and learn from each other. Moving ahead in difficult times requires great teamwork.
This post was written by Heike Schön. Heike is the Managing Director of Lumis and has worked in management positions in clinical research for more than 20 years. Her experience ranges from conducting national and international Phase I clinical trials all the way to registration and post‑marketing activities. She had positions within contract research organisations (CROs) and in the biotechnology industry.
Heike holds a master’s degree in psychology from Freie Universität Berlin and a master’s degree in business administration from Schiller International University. Since 2002, she has been active in the Association of Clinical Research Professionals (ACRP) where she also served as a member of the Board of Trustees and as its Chair in 2010. Heike is a regular speaker at international conferences and publishes within clinical research and medical device magazines.