From the Executive Director

Dear Friends:

It’s been a pleasure watching my Tufts CSDD colleagues attend and network at conferences this past month.  Results and implications from many of our recently completed studies have resonated at these meetings.  Among the presentations made, Tufts CSDD reviewed use cases on AI-enabled drug development tasks, discussed new benchmarks on the time and resource investment made by investigative sites in responding to RFPs and qualification visits, reviewed hard data on the impact and ROI of hybrid DCT use, and presented benchmarks on patient and site participation burden.  Visit our website (CSDD.tufts.edu) for more information about these studies. You can also refer to this Insider for listings of upcoming presentations and newly published peer-reviewed articles by Tufts CSDD researchers.

It has been a busy period organizing and facilitating meetings. In late September Tufts CSDD hosted a group of Japanese delegates from Japan’s top academic institutions who are participating in this year’s Mansfield-PhRMA Research Scholars program. In early October Tufts CSDD produced an executive roundtable looking at innovations transforming the regulatory submission process.  And in early November we will be facilitating a custom professional development program for a major pharmaceutical company.  

Planning for our January/February 2025 Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation is well underway.  Now celebrating its 52nd anniversary, this internationally recognized program provides R&D executives — experienced and new —with a comprehensive overview of the drug development process and strategies and best practices to optimize development performance and efficiency. We have an excellent faculty line-up for this interactive virtual program. Contact Sarah Wrobel (sarah.wrobel@tufts.edu) or visit our website (CSDD.tufts.edu) for more information.

Lastly, several Tufts CSDD working group studies are now underway.  Each study has between 10 and 20 sponsor and CRO companies participating. One study is evaluating centralized recruitment practices; another is assessing site management strategies, practices and the long-term viability of clinical trial execution models. A third study, just launched, will examine how sponsor companies are making the transition from legacy high-frequency study monitoring to risk-based monitoring approaches. 

Our working group studies offer a unique opportunity for sponsors and CROs to share experiences and insights and to collaborate with Tufts CSDD on empirical research activity. Please contact me at Kenneth.getz@tufts.edu if your organization is interested in participating in any of our upcoming working group studies.

Thank you as always for your encouragement, feedback and support,

Kenneth Getz

Executive Director, Tufts CSDD

To access hard-hitting Tufts CSDD charts and tables, visit  https://csdd.tufts.edu/impact-reports.

To access a comprehensive list of published Tufts CSDD manuscripts and articles, visit Articles - Tufts CSDD