Services
Sponsor-side safety leadership, complementary to your CRO.
The safety responsibilities that stay with the sponsor when a CRO runs operations: governance, medical judgment, and oversight. Physician-led, and sized to your program.
One team, clear lines
Where ClinRM fits alongside your CRO
ClinRM is the sponsor’s safety function, not a second vendor competing for the same scope. The operational work stays with the CRO; what stays with the sponsor is what we hold.
- Safety governance and the benefit–risk framework
- Medical judgment on causality, seriousness, expectedness
- IND safety reporting decisions
- Signal evaluation and work-up
- Documented oversight of the CRO
- Inspection readiness and sponsor-level PV SOPs
- Case intake and processing
- ICSR data entry and MedDRA coding
- Safety database management
- Expedited submission mechanics
- Reconciliation and query handling
- Day-to-day case workflow
One team, clear lines. ClinRM does not compete with your CRO for operational scope.
Sponsor-side safety & pharmacovigilance
What we own on the sponsor side
Six service lines, weighted to what a pre-IND and Phase 1 program actually needs. Engage all of them, or one.
Safety Governance & CRO Oversight
The sponsor’s own safety system, and the documented oversight regulators expect of the vendor running it. Sized for a clinical-stage company, not copied from a large-pharma quality manual.
- Safety governance structure: safety review committee, charters, and decision rights
- Sponsor-level PV SOPs sized to a clinical-stage company
- Safety data exchange agreements and clearly defined CRO interfaces
- Vendor oversight: case processing quality, reporting timeliness, reconciliation
- PV system gap assessment, CAPA planning, and inspection readiness
Clinical Trial Safety Oversight
Medical monitoring in the real sense: a physician available to the study in real time, making the calls that cannot wait for a committee meeting.
- Real-time medical review of serious adverse events, with causality, seriousness, and expectedness assessed against the Reference Safety Information
- Site safety queries, eligibility questions, and dose-modification decisions
- Dose-escalation review and application of protocol stopping rules in first-in-human studies
- Safety Review Committee participation and preparation of review materials
- Medical assessment of protocol deviations where patient safety is involved
IND Safety Reporting & Regulatory Communication
The reportability determination, and the answer when the agency asks how you reached it. Made by physicians who have defended these decisions before.
- 7-day and 15-day IND safety report determinations
- Aggregate assessment supporting the “reasonable possibility” judgment
- SUSAR reporting decisions and EU coordination
- Responses to FDA and EMA safety questions and information requests
- Clinical hold and partial hold response support
Safety Documents & Periodic Reports
The safety content regulators actually read — authored, not templated, and consistent with the decisions in your safety file.
- Investigator Brochure safety sections and Reference Safety Information
- Protocol safety design: AE and SAE definitions, AESIs, stopping rules, DLT criteria
- Safety Management Plan
- DSUR authoring
- CSR safety sections and integrated safety summaries as the program advances
- PBRER and Risk Management Plans once products reach approval
Signal Detection & Benefit–Risk
Development-stage signal work with physician interpretation. A disproportionality score is an input, not a conclusion.
- Ongoing aggregate review of blinded and unblinded clinical safety data
- Emerging-signal work-up, escalated to specialist clinicians where the question is clinical
- Documented benefit–risk assessment and maintenance of the benefit–risk framework
- Literature and class monitoring for the target and mechanism
- Signal communication to the safety committee and, where required, to authorities
EU QPPV & European Representation
European safety cover from the first trial through marketing authorization, with a QPPV on the bench rather than sourced under time pressure.
- Sponsor safety representation for EU clinical trials, including EudraVigilance and CTIS registration
- SUSAR reporting to EudraVigilance
- EU QPPV services once a marketing authorization is held: permanently accessible, multilingual
- Local QPPV coordination in the UK, APAC, and MENA on request
- Post-approval signal management via EVDAS, with liaison to PRAC and competent authorities
Therapeutic area expertise
Specialist depth across disease areas
Our physicians have held senior safety roles across major biopharma and the US National Cancer Institute, and have contributed to multiple global regulatory approvals.
Oncology
Dose-escalation safety under FDA Project Optimus; IO, ADCs, targeted therapy, cell and gene therapy; irAE evaluation; DLT definitions and stopping rules; class-effect assessment for TKIs.
Neurology & neuropsychiatry
CNS adverse event evaluation (seizure, cognition, neurobehavioral); suicidality risk per C-SSRS and FDA guidance; rare neuromuscular and movement-disorder programs.
Immunology, ID & vaccines
Phase 1 vaccine safety governance; AESI evaluation (myocarditis, GBS, thrombotic events); biodefense programs (COVID-19, Ebola, anthrax, malaria); CRS and immunogenicity interpretation.
Rare disease & gene therapy
Safety oversight for ultra-small populations; specialized stopping rules for gene therapy; safety strategy for viral-vector and RNA platforms; first-in-human risk-mitigation planning.
Early phase / first-in-human
SAD and MAD oversight with real-time medical monitoring; CRS and infusion-reaction adjudication; safety leadership for novel biologics; stopping-criteria and benefit–risk framework design.
Regulatory & benefit–risk strategy
FDA Type A/B/C meeting preparation with safety focus; benefit–risk frameworks for breakthrough and fast-track programs; safety alignment across clinical, regulatory, and quality.
Built-in specialist escalation
ClinRM ExpertConnect
When a safety question needs a clinician who has treated these patients — not only reviewed their charts — ExpertConnect is how that clinician joins the review.
Traditional PV vendors employ safety scientists. ExpertConnect gives you practicing and former academic clinicians — nephrologists, oncologists, neurologists — who understand the disease, the patient, and the clinical context behind every adverse event.
Start with the gaps, not a contract.
Most engagements start with a short conversation about your program — where the safety gaps are, and whether we are a fit.