GCP

ARTICLES

Strategies to Reduce Inefficiency of GCP Training

How much training do clinical investigators and clinical study staff need to stay up to date on good clinical practices, particularly to ensure compliance for multiregional clinical trials? In a recent study, the Clinical Trials Transformation Initiative evaluated the content, frequency, format and enrollment evidence of GCP training and provided recommendations to improve the efficiency of GCP training. Jonathan Seltzer, the director of clinical research at the Lankenau Heart Institute and a co-author of the study, “Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency,” talks with CTA about the findings. Read More

How Diverse Are Clinical Trials?

A lack of diversity in clinical studies can have crucial health implications in minority populations, as medicines are launched with little understanding of genetic interactions, researchers and regulators warn. Read More

PRODUCTS

Clinical Investigator Questions, FDA Answers

$397.00
FDAnews’ staff has culled through questions submitted to OGCP about investigations and curated more than 90 of the most relevant responses for you — segmented by category — saving you the time and frustration of sifting through the questions and responses. View

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The Special Protocol Assessment: Winning FDA Support for Trial Design management report digs into the draft guidance to find vital information.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

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

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
Data Integrity in Clinical Trials

Data Integrity in Clinical Trials: Ensuring Valid Results

$397.00
Let’s face it. You’re under more pressure than ever to conduct more complex and larger trials — and to do them faster. View