New Trends and Tactics in Outsourcing

Within the push for greater diversity of patient populations in clinical research has come more attention on inclusive trial designs. Key to this effort have been new methods of outsourcing that have emerged in recent years. This has occurred in step with the rise of integrated research organizations (IROs), which are bringing trials directly to community-based research centers and doctors’ offices, as opposed to more traditional academic sites. No matter how you slice it, barriers to clinical trial participation are being broken down to allow greater access for patients. Our October issue of Applied Clinical Trials dives into some of the related outsourcing methods.

We have four features on tap this month, with the first focusing on the current landscape of sites, including the potential advantages and disadvantages of consolidation into larger site networks. Authored by an industry contingent, including clinical trial leaders with Big Pharmas GSK and Merck, and the CEO of Atlas Clinical Research, the experts frame their in-depth reporting with results from a survey of clinical operations executives aimed at testing their knowledge on this shift toward consolidated site networks.

Next up is a use case on the strategic selection of functional service providers (FSPs). In this new age of outsourcing, FSPs are supporting sponsors through oversight and leveraging business operations data, factors that make selecting the best provider for your study increasingly important. October’s third feature is a dive into IROs from a physician investigator perspective. As mentioned, trials are being brought directly to patients, which can create a stronger bond and sense of trust from patients and communities. Wrapping up our features is a piece by Steve Young, chief scientific officer at CluePoints and ACT Editorial Advisory Board member, on optimizing practices in risk-based quality management. He emphasizes the need for continuing education and increased awareness of risk-based approaches.

In addition to our regular coverage, we’re happy to share some highlights from DPHARM 2024. Representing ACT was Nico Saraceno, editor of our sister publication, Pharmaceutical Commerce, who attended sessions and spoke with industry leaders on-site in Philadelphia. For full coverage, visit https://www.appliedclinicaltrialsonline.com/latest-conference. Thank you for reading.

Mike Hennessy Jr is president and CEO of MJH Life Sciences®