Q1) What challenges can we expect for the new laws and regulations in 2023?
In 2023 the biggest challenge will be supporting our clients to adapt to the use of the Clinical Trials Information System (CTIS). From 31 January 2023, applicants must submit new applications for clinical trials using CTIS. Some of our clients have found it challenging to adapt, but we are here to guide our clients to successfully transition to this new database. By 31 January 2025, all on-going clinical trials must transfer to CTIS.
Q2) How exactly will Lumis be supporting their clients with the implementation of the Clinical Trials Information System (CTIS)?
Lumis has adjusted to the new needs to oversee activities required by the Clinical Trials Regulation (CTR) and as part of our responsibility as legal representative, we perform a regular review of the study database CTIS to ensure optimum quality in the control of the clinical study. We are convinced that submitting the new applications using CTIS will be incredibly beneficial to accelerate the development and success of clinical Studies.
Q3) What are the consequences for Biotechnology and Medical Device Small and Medium-Sized Enterprises (SMEs)?
Nowadays, more than two-thirds of novel treatments for marketing approval have their origins on SMEs. This exponential growth of lean, nimble SMEs is leading to some factual challenges when developing treatments including in the clinical space. By having a legal representative that is fully aware of the new regulations of the clinical studies, we can provide peace of mind to the sponsor in terms of quality, effectiveness, and privacy in the development of their study.
Q4) Lumis does not only act as a legal representative, but Lumis also offers consulting services to SME and Medical Device companies. What is essential to be successful when outsourcing clinical trials?
It is essential to plan early and take the time to carefully select your CRO (Contract Research Organisation) and vendors. Cultural alignment between the Sponsor and the CRO partner must be taken into account as well as the required search for a partner with a particular level, for example therapeutic or technical expertise. Especially, for SME it is very important to consider how adaptable the CRO will be and their level/willingness to tailor their service for the required subcontracting services. We recommend that your CRO provides a proven track-record and references that they have worked in a similar indication, geographic locations and with comparable size of sponsor.
Q5) Lumis International is celebrating its 10-year anniversary in 2023. What are your key takeaways from the last 10 years in vendor management in clinical trials for SMEs and what can we expect from the next 10?
Yes, we are celebrating 10 Years in April 2023!
We have established Lumis as the company of first choice for legal representation in Europe. We have expanded the business to Switzerland and after Brexit also to UK. We continue to grow and expand our capabilities in this specific service line.
We have also supported many clients to manage their vendors and CROs in these past 10 years. We have a lot of advice on this topic. Here are our top three, which you can also find in our publications.
- Involve the CROs and vendors as early as possible to obtain input on the study planning.
- Prepare an outsourcing strategy, define the goals, expectations, budgets and timelines.
- Integrate governance models and thorough oversight plans to ensure success.
And what can you expect from the next 10 years? good question! 10 years is a long time and we do not know which changes and challenges will come up, but we know that we will always be at the forefront to understand trends in clinical research and development and to adjust our services where needed.
I am looking forward to celebrating our 10th anniversary with our valued clients, partners and team!
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.