Data Integrity

ARTICLES

PRODUCTS

ICH E6 GCP Revisions - Webinar CD/Transcript

$287.00
Every clinical trial operator will feel the impact of the major revision of the ICH E6. The revision, known as ICH E6 (R2) GCP, will impose new requirements to use state-of-the-art technology ... force changes in trial design, conduct, oversight, recording and reporting ... and all the while, continue insisting on highest standards of human protection and data integrity. View

The FDA Under a New Commissioner - Webinar CD/Transcript

$287.00
Likely new FDA Commissioner Scott Gottlieb is an old agency hand thrust into a new role. Will he toe the Trump line ... or show independence? Is his past a guide ... or will he strike out in new directions? Will he ease new drug and device approvals ... or toughen them? Increase inspections ... or ease off? More 483s and warning letters ... or fewer? View

Clinical Research Manual

$380.00
Clinical Research Manual brings together guidance on everything from pharmacokinetics and study design, to recruitment, monitoring, statistics… all the problem compliance areas you need to stay on top of to conduct clinical trials that will stand up to regulatory scrutiny. View

Medical Device Clinical Evaluation Reports - Webinar CD/Transcript

$287.00
Michelle McDonough — Associate Director, Regulatory and Clinical Affairs, MCRA — discusses the requirements for CERs and their place in supporting new device certification and maintaining certification. She will cover best practices for completing CERs, complying with regulations including the MEDDEV 27/1 Rev 4 guidance. View

Clinical Trial Compliance Guide: FDA Requirements

$397.00
The FDA has issued more than 100 guidance documents relating to clinical trials covering topics from the Animal Rule to validating software used in studies. If you had to pull all of them together yourself — and get the right version — it would take you hours. View

Conducting an Internal Audit for Pharmaceutical and Medical Device Companies - Webinar CD/Transcript

$101.00
Internal audits are critical element of your quality management system. Your approach must be both systematic and documented to remain compliant. Information from an internal audit provides management with the knowledge they need to show how effectively the company maintains the quality of the product and their processes. View

The Reality of Doing Business in Cuba in 2017 - Webinar CD/Transcript

$287.00
Join Jennifer Diaz — a board certified international attorney — as she discusses the realities of doing business in Cuba including whether the new Trump administration will continue with efforts to open up Cuba to U.S. business or if we will see a return to the more closed and distant relationship of the past. View

Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices

$397.00
The new FDAnews management report Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices will show you, step-by-step, how to properly design and implement your risk-based clinical trial monitoring program to fully satisfy the FDA’s requirements. View

Human Subjects Questions, FDA Answers

$397.00
FDAnews’ staff has culled through questions submitted to OGCP about human test subjects and curated more than 100 of the most relevant responses for you — segmented by category. View

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

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