Trial Design

ARTICLES

PRODUCTS

Special Protocol Assessment: Winning FDA Support for Trial Design

$397.00
The Special Protocol Assessment: Winning FDA Support for Trial Design management report digs into the draft guidance to find vital information. View

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

$287.00
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

$287.00
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

Top Ten Data Integrity Traps: How to Find and Fix Problems

$177.00
The Top Ten Data Integrity Traps report shows you where most data integrity problems occur and helps you create a plan to weed them out — and keep them out. View

GCP Questions, FDA Answers

$397.00
FDAnews’ staff has culled through hundreds of questions posed to OGCP and curated more than 175 of the most relevant of responses for you — segmented by category — saving you the time and frustration of sifting through the questions and responses. View

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

$397.00
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

Special Protocol Assessments - Webinar CD/Transcript

$287.00
When should you consider pursuing an SPA? If you do, how long will it take? Join Alexander Varond — Associate at Hyman, Phelps & McNamara — for an overview of the SPA program and a discussion of the impact of the FDA’s new draft guidance on sponsors and regulatory affairs professionals, and key opportunities and challenges for sponsors. View

Training Staff to Detect Data Integrity Issues - Webinar CD/Transcript

$287.00
Over the past few years, global regulators have increased their focus on data integrity systems. Who is responsible for data integrity? Find out in this 90-minute presentation. View

Pediatric Clinical Trials Regulation - Webinar CD/Transcript

$287.00
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

$287.00
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

$287.00
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

$287.00
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