CROs & Contract Research
Contract research organizations — conducting clinical and nonclinical studies, bioanalysis, and pharmacovigilance under sponsor oversight.
Contract research organizations (CROs) run studies on behalf of sponsors — clinical trials, nonclinical/toxicology studies, bioanalysis, and, increasingly, pharmacovigilance case processing. They generate the data that supports a marketing application, so the integrity and traceability of that data is the product. CROs span the full development pipeline from first-in-human through post-marketing safety.
Clinical work follows Good Clinical Practice (ICH E6(R2), moving to E6(R3)), the EU Clinical Trials Regulation (536/2014), and FDA 21 CFR 50/54/56/312. Nonclinical safety studies follow Good Laboratory Practice (FDA 21 CFR Part 58, OECD GLP). Pharmacovigilance work follows EU GVP and ICH E2A/E2D. Computerised systems throughout are governed by 21 CFR Part 11 and EU GMP Annex 11.
The sponsor may delegate trial conduct to a CRO but cannot delegate accountability — under 21 CFR 312.52 any transferred obligation must be described in writing, and the sponsor retains oversight duty. The CRO executes to the protocol and its SOPs; the sponsor performs risk-based oversight, reviews the Trial Master File, and remains answerable to the health authority for the study.
Data integrity & the audit trail
ALCOA+ clinical and bioanalytical data with intact audit trails across EDC, LIMS, and eTMF — the evidence a regulator relies on to trust the submission.
Sponsor oversight & delegation
Clear written transfer of obligations, delegation logs, and the risk-based monitoring that lets the sponsor demonstrate real oversight of delegated work.
GLP study conduct
The study director model, protocol adherence, and independent Quality Assurance Unit that define a defensible 21 CFR Part 58 nonclinical study.
Pharmacovigilance timeliness
Case intake, assessment, and expedited reporting within GVP timelines — where a missed clock is itself a finding.
- ›Data-integrity gaps in clinical, bioanalytical, or safety systems
- ›Sponsor oversight that is documented on paper but not exercised in practice
- ›Trial Master File that is incomplete or not inspection-ready
- ›Expedited safety reports filed outside the required GVP/ICH timelines
Derived from the 24 standards SPEQ decodes for this sector.
Intelligence for CROs & Contract Research
The enforcement actions, guidance, and quality signals that shape sponsor–provider oversight — curated for CROs & Contract Research and delivered free each week.