Question 1

What is CAP certification?

Accepted Answer

CAP certification is a quality standard that verifies a laboratory or organization meets specific regulatory and operational requirements. For CROs, holding CAP certification demonstrates that their facilities, procedures, and staff comply with industry-recognized benchmarks for data integrity, safety, and scientific rigor required by regulatory agencies.

Question 2

Why is CAP certification important for CROs?

Accepted Answer

CAP certification is important because regulatory agencies often require data from CAP-compliant facilities for drug approval submissions. Working with a CAP-certified CRO reduces the risk of regulatory rejection, ensures study data meets quality standards, and gives sponsors confidence that the CRO's processes have been independently verified against established benchmarks.

Question 3

How do I verify a CRO's CAP certification status?

Accepted Answer

Request a copy of the CRO's current CAP certificate and check its validity dates. Cross-reference with the issuing body's public registry when available. During your qualification audit, review inspection reports, corrective action history, and any conditions placed on the certification. Ask for documentation of ongoing compliance activities such as internal audits and proficiency testing.

CAP Certified CROs

Labcorp Drug Development

PPD (Thermo Fisher Scientific)

Celerion

Covance Genomics Lab (LabCorp)

Eurofins Scientific

Medpace

QPS