PRIMARY ENDPOINT VENDORS
Because critical endpoints deserve critical oversight.
Clinical trials increasingly rely on specialized vendors to generate, assess and manage data that can influence trial outcomes. VedX provides independent quality audits of these critical partners across therapeutic areas and clinical development programs.
INDEPENDENT OVERSIGHT
Why Independent Oversight Matters?
When a vendor generates data that supports a primary endpoint, its quality system becomes part of your trial’s regulatory risk. Sponsor oversight is essential, but independent, systematic audits provide an objective assessment of whether critical processes, systems and data controls are working as intended.
What We Cover
We audit critical and specialized vendors supporting clinical trials, with a focus on the processes, data and systems that can directly impact patient safety, data integrity and study outcomes.
- Central Imaging
- Endpoint Adjudication
- eCOA / ePRO
- Central Pathology
- Respiratory / Pulmonary
- Sample Management & Biorepository
- Central Laboratory
- Biomarker & Genomic Testing
- Cell & Gene Therapy
- Central ECG & Cardiac
- Bioanalytical & Immunogenicity
- Digital Endpoints & Wearables
Our Approach
- 01
Vendor Qualification Review
Assess the vendor's quality system and readiness before contracting or trial start.
- 02
Ongoing Oversight Audits
Conduct periodic on-site or remote audits throughout the trial lifecycle.
- 03
Data Integrity Review
Evaluate the vendor's data handling against the endpoint's regulatory sensitivity.
- 04
Corrective Action Follow-up
Track CAPA closure and re-verify compliance before database lock or submission.
Have a specialized vendor audit requirement?
Let's discuss your needs and determine the right audit approach.