Advanced Clinical Blog

By

Subscribe Here!

Topic: Quality Validation

Quality & Validation Technology Insights

Four Considerations for Implementing a Successful TMF Transformation Project
By Fran Ross on October 29, 2021

When you need a Trial Master File (TMF) transformation, whether it’s moving a paper TMF into a validated electronic repository or transferring a live trial’s eTMF from CRO to Sponsor,...

Continue Reading

Quality & Validation Technology Insights

35th Annual SQA Takeaways: Emerging Trends in Quality, Compliance and More
By Advanced Clinical on May 15, 2019

This year, the 35th Annual SQA Meeting and Quality College was home base for many of the Advanced Clinical Quality and Validation team members. With three of our teammates residing in...

Continue Reading

Quality & Validation Technology Insights

SCOPE 2019: Risk-Based Monitoring Delivers Big on Quality

Continue Reading

Quality & Validation Technology Insights

A Timely Part 11 FDA Draft Guidance for Systems Validation for Clinical Trials Development

The use of electronic records in clinical research is growing in practice and complexity for Sponsors, investigators, IRBs and CROs. As a response to that growth in 2017, the FDA issued...

Continue Reading

Quality & Validation

Strengthen Your Management Control System With These Three Recommendations

The impact of management on an organization can take a company to new heights or lead it to its demise. Leaders of pharmaceutical, biotech and medical device companies have the added...

Continue Reading

Quality & Validation Clinical Staffing

How to Successfully Build a Risk Based Monitoring Team 
By Melissa Mauriber on February 23, 2018

As industry adoption of Risk-Based Monitoring (RBM) rises, so does the question of how moving from traditional research models to RBM will impact clinical research team structure. While...

Continue Reading

Stay up to date