Sponsor-side drug safety
Safety leadership before the full-time hire.
Hiring a CRO does not transfer the responsibility. The sponsor still owns the medical judgment and safety governance regulators expect. ClinRM takes patient safety off the CMO’s desk — physician-led, on your side of the table, working as one team with your CRO.
- Stage
- Pre-IND through Phase 2
- Model
- Sponsor side, alongside your CRO
- Leadership
- Physician-led, 20+ years average
- Coverage
- Global
- EU QPPV
- On the bench
The gap
A CRO runs safety operations. The sponsor still owns safety.
Regulators hold the sponsor accountable for medical judgment and safety governance — whoever processes the cases.
The CRO runs operations
Case intake and processing, the safety database, MedDRA coding, expedited submissions. Necessary work, well handled where a capable CRO is in place.
The sponsor keeps responsibility
Causality and benefit–risk judgment, IND safety reporting decisions, signal evaluation, governance, documented vendor oversight. None of it transfers under contract.
The gap lands on the CMO
At pre-IND and Phase 1 there is rarely a dedicated safety leader, so patient safety sits with a CMO already carrying clinical, regulatory, and manufacturing.
A safety decision is a medical decision. It should be made by a physician prepared to defend it — to regulators, in an inspection, on the record.How ClinRM works — every engagement supervised by a qualified MD
What we do
The sponsor-side safety function your program needs
Draw on the full bench or a single expert. Scale as the program grows, and step back once you hire your own safety leader.
Safety Governance & CRO Oversight
The sponsor’s own safety system, and documented oversight of the vendor running operations.
Safety review committee · Sponsor-level PV SOPs · Vendor oversight & SDEAs 02Clinical Trial Safety Oversight
Real-time physician cover for the study: SAE review, dose escalation, stopping rules.
Causality & expectedness · Dose-escalation review · SRC materials 03IND Safety Reporting & Regulatory Communication
The reportability call, and the response when the agency asks a question.
7- and 15-day determinations · SUSAR decisions · FDA & EMA responses 04Safety Documents & Periodic Reports
The safety content regulators actually read, authored by people who have defended it.
IB safety sections & RSI · DSUR · CSR safety · Safety Management Plan 05Signal Detection & Benefit–Risk
Development-stage signal work with physician interpretation, not a database report.
Aggregate review · Signal work-up · Benefit–risk framework 06EU QPPV & European Representation
European safety cover, from the first trial through marketing authorization.
EudraVigilance & CTIS · SUSAR reporting · QPPV servicesThe bench
Physicians who have signed the safety decisions before
Safety physicians, an EU QPPV, and specialist clinicians — engaged as a full team or a single expert, scaled to the stage of the program.
Mohamed Elsafy, MD, MSc
SVP, Drug Safety & Pharmacovigilance
25+ years across the US NIH, global biopharma, and academic medicine. Built global PV infrastructures for oncology pipelines.
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Jitesh Rana, MD, MBBS
President, ClinRM LLC
20+ years in patient safety, pharmacovigilance, and medical affairs. Formerly VP Drug Safety at Dyne Therapeutics.
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Gina Ayala, MSc
Chief of European Operations
16+ years in EU and Middle East medical affairs, drug safety, and clinical development. Local QPPV experience.
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Let’s find the safety gaps together.
A short conversation about your program — where the safety gaps are, and whether we are a fit.
No pitch deck. Bring your protocol synopsis and your CRO scope.