Why Working Groups within BeCRO?
BeCRO’s main objective is to serve the interest of its members by:
• being an industry representative voice on national issues
• promoting knowledge or experience sharing
• providing specific added value support for the daily operational delivery of its members
BeCRO is achieving this via working groups at the national level for Belgian specific matters or for European matters, by joining forces with working parties well established in EUCROF, the European umbrella of which BeCRO is a member.
What is the added value for participants?
Joining a working group contributes to sharing and increase members knowledge, competence/expertise and skills, to influence future regulations and gain visibility through interactions with all stakeholders including (bio)pharma / medical devices industries, regulatory agencies, advocacy groups, etc.
What we try to achieve
• Interact with stakeholders to strive for continuous improvement of clinical research in Belgium
• Creating awareness of issues potentially impacting clinical trials
• Sharing best practices, updates and templates
• Centralising Q&A
• Organising practical workshops
Our different working groups
- Decentralised clinical trials
Decentralised or remote clinical trials (DCT) provide an opportunity to increase patient centricity in the development of new therapies. Decentralising means that the trial is brought to the patients rather than the patient going to the trial. The expected benefits from this approach are well known and have been subject to many discussions, conferences and working groups. Still there are many practical hurdles in doing a DCT and a harmonised regulatory framework is missing.
Remarkably, the recent covid-19 pandemic has forced many of us to be creative in finding ways to assure continuity of ongoing clinical trials, very often in a remote setting. The BeCRO DCT working group is focused on maximising the lessons learned from recent experience and on creating a favourable environment with all stakeholders on board towards decentralising clinical trials with the patient in the centre.
Within the digitalisation working group, we want to prepare our members for the future of digitalisation in clinical trials. Our focus will be on collection of data via wearables and artificial intelligence in clinical trials. Also, in terms of digitalisation, there are some lessons to be learned from the covid-19 pandemic.
We will further investigate electronic consent, tools for remote SDV as well as looking into the possibility of an electronic investigator site file and interaction with the eTMF that is already well established.
Although the GDPR has been already in force for a couple of years, there are still questions and uncertainties. This working group strives to improve the awareness, to inform about various GDPR aspects and to share practices how to become/remain compliant with GDPR.
- Study participant recruitment
How can we assure Belgium remains a competitive place for clinical research after the EU CTR implementation?
Having the right study subjects in our trials at the right pace, the right moment, and the right site. It is a concern for sponsor companies and for the CRO. This working group wants to explore opportunities to increase patient recruitment and develop a strategy to keep Belgium on the clinical trials map.