Data Integrity



Clinical Investigator Questions, FDA Answers

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

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

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

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

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

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

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

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

Writing Effective Standard Operating Procedures - Webinar CD/Transcript

Your standard operating procedures are some of the first things FDA investigators will look at during an inspection.  Yet, in 2015, "inadequate SOPs" was once again a Top 5 most-frequently-cited Form 483 observation. A well-written SOP helps you demonstrate your compliance and say to inspectors: “We know what we are doing — and why. View

Pharma Strategies in Latin America - Webinar CD/Transcript

This two-part webinar CD and transcript will provide valuable insights into the regulatory, clinical and marketing landscape for any company doing or planning to engage business in Latin America, whether exporting, in local partnership or manufacturing within the region. View