Clinical Leader

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25 Tips To Prepare A Clinical Site For FDA Inspection

1 week ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderDuring the past few months, I've interviewed four women (see hyperlinks at the end of the article) who have either been a former FDA investigator or been involved with many regulatory inspections. Additionally, last year I interviewed former FDA investigator Vin Cafiso about his " 20 Things Never to Say to an FDA Investigator" list, and I spoke with another former FDA inspector, Patrick Stone, about what to expect from an FDA inspection.
Insights From 250+ Regulatory Inspections

2 weeks ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderMost of the people I talk to about FDA inspections either used to be behind the badge or have seen a few dozen audits up close. Elisabeth George stopped counting after 250. She didn't just attend those inspections - she ran them. Not as a quality lead or as the person nervously defending CAPAs, but as the designated host responsible for orchestrating the whole production, often at Fortune 500 scale.
Why Perfect Clinical Trial Data Is A Dangerous Myth

3 weeks ago | clinicalleader.com | Dan Schell

By Dan Schell, Chief Editor, Clinical LeaderI've interviewed former FDA investigators before, and each time I come away equal parts entertained and alarmed. Talking to Kara Harrison was no exception. Her résumé spans grading orange juice at the USDA to becoming a sharp-eyed quality consultant after a decade with the FDA, and I knew this conversation would be another one of those "I learned something today" moments.
Debunking Five Misconceptions About Community-Based Research Sites In Clinical Trials

1 month ago | clinicalleader.com | Miranda McLaren

By Miranda McLarenExplore the transformative potential of community-based research sites in clinical trials, particularly in enhancing patient experiences and fostering diversity. Traditional trial models often struggle to recruit minority populations due to logistical barriers, but community-based approaches significantly improve accessibility and engagement.
Why Sponsors Should Be Using Community Research In Obesity And Diabetes Trials

1 month ago | clinicalleader.com | Miranda McLaren

By Miranda McLarenThe obesity drug development landscape is rapidly evolving, driven by the World Health Organization's recognition of obesity as a critical public health problem. With projections indicating over 161.5 million cases in major pharmaceutical markets by 2033, the demand for effective treatments is surging.
How FDA's Guidance On Decentralized Trials Applies To Community-Cased Research Execution And Compliance

1 month ago | clinicalleader.com | Moe Alsumidaie

By Clinical Trial Vanguard and Moe AlsumidaieThe FDA's September 2024 guidance on decentralized clinical trials (DCTs) marks a pivotal shift in clinical research, recognizing the growing integration of decentralized elements like in-home visits, mobile research sites, and telehealth within a regulated framework. This approach is designed to expand accessibility, improve diversity, and enhance participant retention without sacrificing data integrity or safety.
Here's Your 483 - And Your Hug

1 month 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.
Tales From A Site Inspection Veteran

1 month 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.
Continuing Your Research Mission -- Even As Budgets Tighten

1 month ago | clinicalleader.com | Mark Epstein

By Mark EpsteinAmid growing uncertainty in clinical research funding, including proposed budget cuts from the National Institutes of Health (NIH) that threaten indirect support for essential infrastructure, OpenClinica remains a steadfast partner to researchers. These financial constraints place added pressure on clinical trial operations, particularly in areas like staffing, lab space, and technology.
What Is Electronic Data Capture And How Does It Simplify Data Management To Accelerate Success?

1 month ago | clinicalleader.com | Laura Acosta

By Laura Acosta, VP of Product Management, eClinical DivisionElectronic Data Capture (EDC) systems play a pivotal role in enhancing the efficiency of data collection, management, and analysis in clinical trials. By digitizing case report forms and enabling remote access via Software-as-a-Service (SaaS) models, EDC minimizes manual entry errors and ensures data quality through customizable electronic case report forms (eCRFs) with built-in validation.