How Sponsors And Patients Benefit From A Site-Centric Partnership

By Jessica Nicholas, inSeption Group

Creating a site-centric partnership between a pharmaceutical/biopharmaceutical sponsor and a clinical trial site can ease personnel and patient burdens, driving high-quality data collection and documentation. This partnership thrives when all parties involved, including study monitors/regional site managers (RSMs), principal investigators (PIs), patients, and study coordinators, understand the potential challenges and unique needs of each trial and can face them together.

As clinical programs dig deeper into niche patient populations, advanced drug development chemistry, and personalized medicine, trials become more complex and the need for specialized personnel becomes critical. PIs are responsible for ensuring the trial has adequate resources in place, including a site management organization (SMO) if necessary, specialized personnel, and training processes to execute a study according to Good Clinical Practice (GCP) standards and guidelines set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

When these challenges and their associated risks are well understood and appreciated, they can be openly addressed and mitigated before study kickoff, ultimately benefiting the operations and experience for all involved.