Topic

Articles

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

Update on Maintaining TMF Quality

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. 

Clinical Quality and Operations During the Pandemic

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

Affecting Real Change

When this article was published in 1992, Frederick L. Olmstead was the director of the health studies and services division of NCRC, Inc., The Trial Management Organization, Bethesda, MD.

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

Improved Organization and Management of Clinical Trials

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

Achieving Regulatory Success in Phases IIIb and IV

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.

Project Management Platform in an Academic Environment: The EORTC'S Promising Experience

Mary Anne Sabogal is president and chief operating officer with Alliance Healthcare Information, Inc., One Ivybrook Blvd., Bldg. 100, Ivyland, PA 18974, (215) 347-1100, fax (215) 347-1110, email: msabogal@alliancehealthinfo.com, www.alliancehealthinfo.com.

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

Reconsidering Third-Party Companies for Subject Enrollment

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

Clinical Operations