Dan Schell

1 week ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderOver the past few weeks, I've been speaking with former FDA investigators to get their take on what clinical sites are doing right, what they're doing wrong, and what they absolutely must be ready for. One of my favorite conversations was with Tracey Harris, who spent eight years with the FDA conducting inspections across sponsors, IRBs, and clinical sites as part of the Bioresearch Monitoring (BIMO) program.

2 weeks ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderIt's not every day that a mock regulatory inspection reveals a closet full of mold-covered records fused together by water damage and crawling with spiders - but that's exactly what Sarah Moeller encountered during one of her more memorable site visits. Her reaction was decisive: iron out the pages to salvage what could be saved, locate digital backups, and prepare to disclose the issue transparently to regulators.

1 month ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderWhen the FDA clarified that local healthcare professionals (HCPs) involved in DCTs do not need to be listed on Form FDA 1572 (as long as they only perform standard-of-care procedures and are not engaged in research), it initially raised concerns within the clinical research community. The American Society of Clinical Oncology (ASCO) was among the organizations that voiced early apprehension.

1 month ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderThere's been no shortage of opinions around the FDA's DCT guidance, especially when it comes to the integration of local healthcare providers (HCPs). This use of local HCPs in DCTs has been described by some people as a transformative opportunity, but one that comes with complex operational challenges. So, I thought I'd take a closer look into the details of this topic and the common concerns. Why Are We Talking About HCPs & DCTs?

1 month ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderIn my article Local HCPs in DCTs: Big Benefits, Bigger Burdens?, I mentioned the need to implement a centralized system to verify the credentials, licenses, and professional standing of all local healthcare professionals (HCPs) participating in a DCT. There's no right or wrong way to do this, but I did want to follow up and give you this multi-step process that you could use as a template and customize as needed. 1.