Dan Schell

2 weeks 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.

4 weeks 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?

4 weeks 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.

1 month ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderLike many people in this industry, Briana White admits that her career in clinical research was more accidental than planned. "I first heard about clinical research from an advisor while working on my undergraduate degree," she explains. "At the time, I didn't think much about it because my plan was to go onto med school. Eventually I decided against med school, but I still wanted to stay in the healthcare field.

1 month ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderI'm just so busy. I can't think about another thing. I'm super slammed. I cannot add another thing to my plate. If you work at a clinical trial site - especially a smaller one - you most definitely can relate to all these phrases. So if someone suggests that "finance is everyone's job!" you likely will roll your eyes and get back to putting out the next fire of the day.