Clinical Operations & Strategy

A discussion of various topics amongst TMF experts from Questex’s 2020 Global TMF Summit.

A discussion of how sponsors, CROs, and sites are adapting their operational models to maintain patient safety, data quality, and integrity in the COVID-19 pandemic.

Roundtable explores relationships, outsourcing, risk-based monitoring, and site performance.

The very first article ACT ever published shows how many changes the CRO industry has seen in 13 years.

Well-planned studies designed to pinpoint additional data are increasingly important as a result of the EU's emphasis on added therapeutic value.

A new, standard-based approach minimizes the delays between discovery of innovative agents and identification of their therapeutic benefit for patients-critical in cancer research.

Central call centers can relieve sites of tedious scheduling and record keeping, freeing them to focus on physical exams and other core tasks.

Subject safety in clinical trials has received much recent media attention, most publicly because of the death of a young man during a gene therapy study at the University of Pennsylvania.1 Some large and important clinical trials have been halted before their planned conclusions for safety and other concerns (for example, the Women's Health Initiative).2