Aurea M. Flores

Sep 20, 2024 | clinicalleader.com | Jessica Scott |Jennifer Millman |Aurea M. Flores

Webinar: From Crisis to Confidence in Medical WritingThe regulatory submission process is complex and filled with challenges that can jeopardize critical filings. In this session, we’ll explore the key obstacles medical writing submission specialists face today and share proven strategies to ensure successful submissions every time. Click here to learn more.

Sep 14, 2024 | clinicalleader.com | Dan Schell |Aurea M. Flores |BS Pharm |Meghan Hosely

AUGUST'S BEST FEATURED EDITORIALEasy Mistakes To Make During An FDA InspectionAs a former FDA investigator, Vincent Cafiso has heard — and seen — it all when it comes to what NOT to do during an FDA inspection. Here he gives some good advice on who you should have present in the room during an inspection and how you should interact with the investigator. What Clinical Trial Information Do VCs And Investors Actually Want?

Jun 11, 2024 | clinicalleader.com | BS Pharm |Aurea M. Flores

Guest Column | June 11, 2024 By Aurea M. Flores, Ph.D., BS Pharm, CCRP, CHRC, CHC, CHPC, CCEP, PMP, PMI-ACP, RQAP-GCP Traditional project management methodology follows a linear progression from beginning to end, which should theoretically work for clinical trial development. However, in my experience as a former director of clinical research operations, this method yielded a success rate for timely trial opening of less than 5%.