ICMJE Lays Out Data Sharing Proposal

The International Committee of Medical Journal Editors is seeking feedback on proposed requirements involving transparency for clinical trials authors as a condition for publication in member journals. Read More


New Trump Administration, New Republican Congress - Webinar CD/Transcript

The US has a new president, a new Congress, and almost assuredly a new agenda for the FDA — with different policies and priorities than the current administration. What does this mean for FDA regulated industries? View

Using Risk-Based Clinical Trials Monitoring to Improve Data Quality - Webinar CD/Transcript

Are you ready to transform your clinical development through advances in RBM? Join Alan Frederickson and Crona O’Conallain — both of QuintilesIMS — while they share recent research showing how RBM increases study quality and patient safety. View

Adding Pediatric Studies to New Drug Development: A Guide to US and EU Rules

New guidances in the US and EU require drugmakers to include a pediatric component in clinical trials for any new drug that could be used to treat children as well as adults. View

Pediatric Clinical Trials Regulation - Webinar CD/Transcript

What do you need to know about upcoming regulation changes to pediatric trials and drug development? Dr. Martine Dehlinger-Kremer — Global Vice President, Medical & Regulatory Affairs at SynteractHCR — helps attendees understand the landscape for pediatric drug development. View

Spreadsheet Validation 2016 - Webinar CD/Transcript

What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View

The New EU MDR — Are You Really Ready? - Webinar CD/Transcript

Are you ready? The EU has reached agreement on one of the most disruptive revisions to medical device regulations in decades. You have 3 years to become compliant — but you need to start planning your implementation now! View

Preparing for an FDA Preapproval Inspection - Webinar CD/Transcript

It’s time for your preapproval inspection. Are your sites prepared? Don’t let the FDA doubt that your method of analysis or manufacturing practices are what you claim them to be. View
Data Integrity in Clinical Trials

Data Integrity in Clinical Trials: Ensuring Valid Results

Let’s face it. You’re under more pressure than ever to conduct more complex and larger trials — and to do them faster. View

Correcting Misinformation in Social Media - Webinar CD/Transcript

It’s happened again. A social media post. And it’s inaccurate. And someone — a customer perhaps — is sure to believe it. What can you do — other than grind your teeth in frustration? View

Medical Device Clinical Evaluation Reports - Webinar CD/Transcript

A CER is a living document — required for the EU market — that includes the clinical data, the appraisal and analysis stages of the evaluation, and conclusions regarding safety and performance. Failing to make consistent updates to a CER could put your trial at risk. View
Title 21 CFRs - Three Volume Set

Three-Volume Clinical Trials Title 21 CFR Set

The federal government has compiled the new 2016 CFR volumes. View
Title 21 CFRs

Nine-Volume Title 21 CFR Set

The federal government has compiled the new 2016 CFR volumes.