Inspections and Audits

ARTICLES

Report Outlines Strategies for Risk-Based Monitoring

As centralized risk-based clinical trial monitoring becomes the norm, sponsors are gaining access to broad overview data on research and compliance trends that can help them identify both real and potential problems across their trial locations. Read More

Trial Investigator Warned Over Lack of SOP Documentation

A San Diego, Calif.-based clinical researcher received an FDA warning letter over its lack of documentation of standard operating procedures for overseeing studies and details of in-service protocol and specimen handling training in a Form 483 response. Read More

FDA Reduces Clinical Hold On Tekmira’s Ebola Drug

Canadian biotech company Tekmira is set to restart a Phase I trial of its TKM-Ebola RNA interference therapy in the coming weeks, after the FDA downgraded a partial clinical hold that allows the company to administer repeat doses not greater than 0.24 mg/kg/day. Read More

Expert: Clearly Define Roles Of the Central IRB

Clinical trial sites should determine their compatibility with central institutional review boards, including whether software they use to interface with the local IRB is capable of handling an outside review board, an expert says. Read More

PRODUCTS

Combination Products and Cross-Center Reviews - Webinar CD/Transcript

$187.00
Mapping out a regulatory pathway for drug/device/biologic combination products remains one of the most difficult regulatory challenges for life sciences innovators. Join David M. Fox — Partner, Hogan Lovells — for a close look at the FDA’s new authority governing combination products and several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. 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

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

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

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

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

Medical Device Clinical Evaluation Reports - Webinar CD/Transcript

$287.00
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

$287.00
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

$327.00
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