Thank you for requesting the article: Understanding Regulations and Validation Processes for Biomarkers
Click here to download
In this article, Chris Daniels, PhD, Director, Clinical Laboratory Sciences at Medpace’s central laboratory answers questions we frequently hear from Sponsors about the regulations and processes for biomarkers. Click below to see the questions he addresses:
- What regulations and guidelines do Medpace’s central laboratories follow?
- What are the GCLP guidelines?
- Why was the GCLP guidelines created?
- Is GCLP a regulation?
- What are the CLSI and BMV guidelines?
- What guidelines do we follow for validations?
- Does the FDA require that biomarkers follow the BMV guidance?
- Is there an overlap between the guidelines and regulations?
- What is a CLIA/CAP laboratory?
- Is CLIA a requirement for all lab work?
- Are there exceptions to this rule?
- Given that Medpace is global, do all our labs follow all the same regulations?
- Are there additional regulations in other countries that we must follow?
- Are there other agencies like the FDA that Medpace must follow regulations?
- Is GLP for non-human trials?
- When should a bioanalytical laboratory vs. a central laboratory be used?
- Why is it essential to have an experienced lab team?
- How do we help Sponsors understand the different guidelines, regulations, and accreditations?
- What is a validation plan, and why is it important?
- Do you have some idea of what you need to see to consider it a successful experiment?
- Who writes up the validation plan?
- After the validation plan is written and reviewed, where does it go?
- How long is our turnaround timeline?
- What are the types of validations Medpace can do?
- What’s involved with feasibility?
- When is the validation report written?
- Who writes the validation report?
- After the validation report is reviewed by the lab personnel, where does it go?
- What’s the importance of having a team of PhD scientists?
- In addition to having experienced Medical Technologists, how do PhD scientists ensure quality?
- How important is it for central labs to be integrated with Medpace CRO?
- Why is it essential for Sponsors to get a lab partner involved early on?
- Is Medpace the right partner for biomarkers?
To request more information about our central laboratory capabilities contact us.