Learn about the multiple benefits that incorporating a multi-site approach can provide in early-phase clinical research, the “red and green flags” to look out for when working with a CRO, the importance of the “non-data stuff.”
Host Lisa Sanford is joined by Kat Connors, Director, Multi-Site Clinical Trial and Strategic Operations at Altasciences, as they discuss the momentum growing behind using a multi-site strategy, with a notable uptick in demand in the last few years. With multi-site solutions enabling access to more robust trial data, access to an expanded patient network, the opportunity to simultaneously work with specialty and healthy population branches, as well as improved trial efficiency, there is certainly more than one reason to tune in to this episode and hear more from their conversation!
(00:00) - Introduction: Patient access and diversity in early phase trials
(01:30) - Meet Kat Connors and her clinical research journey
(03:54) - What sponsors should expect entering the clinical phase
(05:44) - Why speed and flexibility matter in early development
(06:57) - Combining healthy volunteer and patient cohorts
(09:28) - Building a patient recruitment strategy early
(11:36) - Expanding patient access through a multi-site network
(13:02) - Competing for specialty patient populations
(15:29) - How site feasibility and selection work
(18:35) - Live feasibility and engaging sites before study award
(20:05) - Using site expertise to strengthen study design
(21:50) - Healthy volunteer vs. patient recruitment
(23:07) - Accelerating site startup, contracting, and IRB review
(25:41) - The role of project management in multi-site trials
(28:07) - When does a multi-site strategy make sense?
(28:44) - Case Study: adding a patient arm mid-study
(30:47) - Managing risk and consistency across multiple sites
(32:39) - The early phase CRO difference
(35:48) - Green flags when choosing a clinical partner
(37:43) - Incorporating sponsors’ preferred sites
(40:39) - The “non-data” side of successful clinical trials
(41:59) - Maintaining quality across external sites
(44:48) - Managing budgets and avoiding surprise costs
(47:02) - The future of early phase patient trials
(48:18) - Closing thoughtsAbout Off-Label With Altasciences:
Off-Label presents candid conversations about the drug development industry from an insider perspective. We discuss trending topics and new developments alongside industry experts. Whether you’re drug development-curious or a seasoned veteran, enjoy as we peel back the label.
About Altasciences:
Altasciences is a drug development organization dedicated to safely accelerating early-phase development for biotech, biopharmaceutical, and pharmaceutical companies. By combining the scale and expertise of a large CRO/CDMO with the flexibility and personalized approach of a mid-size partner, Altasciences delivers unified solutions across nonclinical, clinical, bioanalytical, formulation, and manufacturing services. Through intentional integration and true collaboration, the company removes barriers from lead candidate selection to clinical proof of concept—helping sponsors save time, reduce complexity, and make confident, data-driven decisions that enable earlier returns on investment. Guided by over 30 years of experience and a commitment to quality, integrity, and partnership, Altasciences enables clients to reach critical milestones faster and with greater confidence. Altasciences… Drug Development, Reimagined.™
