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Developing & Implementing Efficient Methods for Monitoring Investigator Initiated Studies without Crossing into Sponsorship Territory; Understanding the Evolving Legal Framework for IIS in Europe, and Underlining the Overall Value of Investigator Research


As pharmaceutical and medical device corporations continue to engage with investigators in external research to support new and existing products, the focus on monitoring these important studies has never been more important. Working with investigative sites from the initial outset of the study and remaining engaged with the study site throughout the duration of the trial in order to assess the outcomes, monitor the progress as well as assist the sites in meeting deadlines and milestones is a top priority for every manufacturer. As such, a considerable focus of Q1 productions’ 4th Annual EU Investigator Initiated Studies Conference focused on the best practices of leading organizations as they work to rigorously monitor their investigators without crossing into territory that might be considered study sponsorship.

While many companies have agreed upon an internal definition of study sponsorship and have set guidelines for the support of investigator research, there is still considerable uncertainty within the industry related to the exact point at which a company becomes a sponsor of a clinical trial. New regulatory requirements throughout the European continent are also causing concern for individuals in the industry, many of whom are unsure as to the best methods for moving forward in a compliant and legal manner.

With many challenges to overcome in order to successfully design, collaborate and execute an investigator initiated study, there is much value in meeting as an industry in order to share knowledge and expertise. Ultimately, this program allowed participants an opportunity to discuss and highlight the benefits of investigator research, and strategies for deriving the greatest possible value from these research programs. Here are some testimonials from distinguished attendees of this conference:


“I very much enjoyed working with you on this meeting and I found it very interesting especially as there was a very high level of interaction from the audience. The break out session for pharma was particularly interesting and a very good idea!”
Senior Medical Affairs Director, CELGENE


“Very nice to have a mix between theory, sharing best practices and practical recommendations by lawyers.”
Senior Medical Affairs Manager, MEDTRONIC Spine & Biologics


“Thank you. Great Meeting.”
Manager Clinical Affairs, Volcano Corporation


“I really appreciated the meeting. In my opinion it was even better than last year. Very high quality and good discussions.”
Manager Post-Market Studies EMEA, Abbott Medical Optics




  •     Clear Understanding of the Investigator’s Role and That of The Industry in IIS
  •     Strategies to Maximize ROI in Investigator Initiated Study Collaborations
  •     IP Protection: Ensure Your Company’s IP is Perfectly Safeguarded When Engaging in IIS
  •     Learn How to Better Handle Investigator Payments in Full Transparency & Compliance
  •     Strategies to Enhance Monitoring and Data Collection in the IIS Setting through Efficient Technology
  •     Exclusive Insight on the Investigator Interest Research Group Developments and Guidance


Eric Jahnke | Marketing Manager | Q1 Productions
312.955.0424 | marketing@q1productions.com