With European regulations changing and clinical trial budgets becoming tighter and tighter, it has never been more important for pharma and biotech companies both big and small to optimize their clinical operations and outsourcing strategies. The 5th Annual Outsourcing in Clinical Trials Europe conference took place in Dusseldorf, Germany in May 2015 and brought together over 300 leading clinical executives from across Europe to discuss and consider the key challenges affecting the European clinical trial industry.
The conference consisted of a packed program, with over 30 senior level speakers from pharmaceutical giants, thriving biotechs and informed service providers to give a well rounded view on best practice strategies for effective clinical operations and outsourcing processes.
Day one kicked off with a focus on vendor selection and Heike Schoen, Director of Clinical Operations at Mologen gave a small sponsor perspective on working with a large vendor. Based on real life experiences from Mologen; this presentation provided a unique insight into determining appropriate division and allocation of resources both internally and externally as well as debunking the myth that small sponsors are better off working with small vendors. This led nicely into an interactive panel discussion with input from companies big and small into conducting effective Bid Defense Meetings where it became clear the key priorities were; preparation, open communication and effective assignment of roles, to ensure a smooth start to a trial.
The audience then had the chance to hear about the latest developments in the new EU Clinical Trials Regulation; forecasting the timelines and evaluating how sponsors and vendors alike will need to adapt to meet the preconditions for the new EU Regulation. As well as being an informative presentation, this session also highlighted the ‘silver lining’ for speakers and considered the key advantages that the new regulation would offer.
Another interactive session explored the pros and cons of conducting trials in different European markets. This informal discussion-led panel provided the perfect platform for the audience to give their perspective on different European markets. It was clear that the overall consensus from the panellists and audience alike was the need for strong partnerships with vendors to ensure effective trial management in multiple markets. This all relies on effective training and ‘buy-in’ from vendor CRAs to ensure site management is done to required levels of quality and deadlines. For small sponsors, the importance of effective branding was also highlighted. Small sponsors will also include their vendor logos and information as they may be more recognizable to sites and patients and therefore promote more effective engagement.
The conference sessions were then split into two separate streams to allow attendees to tailor their agendas, selecting topics from Regulations, Finance, Quality Assurance and Trial Types. Key highlights from this afternoon included a presentation from Actelion that explored balancing financial and operational perspectives when running a clinical trial. This unique perspective explored the importance of having a standardized Scope of Service Document in place, explaining in detail what services sponsors want to buy to allow effective review by the whole team (in the same order and format). This document should encompass all aspects of requirements, including SOPs, timelines, rates, budgets and payment schedules to ensure mutual understanding and avoid surprises midway through the trial. Another key highlight was the viewpoint of a ‘pharmaceutical giant’, with a presentation from Janssen on promoting the idea of a true partnership between sponsor and vendor, rather than a ‘customer-service provider’ relationship. This session explored the key advantages of developing mature partnerships with long-term relationships in mind to promote an innovative and collaborative mindset from both vendor and sponsor. To enforce this mindset of a true ‘partnership’, communication is of the upmost importance to further strengthen liability and responsibility, without turning into a ‘blame game’. It was clear that platforms such as Outsourcing in Clinical Trials Europe are imperative for allowing such communication to promoting a partnership approach to the benefit of sponsor and vendor companies, the sites and ultimately, the patient.
Alongside the presentations at the event, there was a busy exhibition area where a mixture of service providers, large and niche, full service and functional, were showcasing their technologies, products, and capabilities. The event offered a fantastic opportunity for new partnerships to be made, existing relationships to be strengthened and common challenges to be discussed and overcome to the advantage of the European clinical community.