🇺🇸 US +1 617-803-7730  |  🇪🇺 EU +31 646435422  |  ✉ Contact@ClinRM.com
Drug Safety & PV Therapeutic Areas ExpertConnect Medical Affairs Intelligence & Insights Contact
Clinical Risk Management

Expert-Led Drug Safety.
Deployed When You Need It.

No retainer. No procurement delays. Physician-level expertise across US, EU, and India — activated within 48–72 hours.

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Physician-Led
Every engagement supervised by a qualified MD
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48–72hr Deployment
Pre-contracted framework bypasses procurement delays
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Zero Retainer
Establish your safety net at zero standing cost
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Global Coverage
US · EU · APAC · MENA · UK · India
The ClinRM Platform

Four integrated capabilities. One physician-led network.

Pillar 01
ClinRM Core
PV & medical affairs specialists across all product lifecycle stages
Pillar 02
ClinRM ExpertConnect
Rapid access to board-certified specialist clinicians
Pillar 03
ClinRM Intelligence
AI-powered product surveillance & investor safety analysis
Pillar 04
ClinRM Insights
Strategic intelligence via ClinicalTrialsDaily.com
ClinRM Core — Drug Safety & Pharmacovigilance

End-to-End Pharmacovigilance Support

From first-in-human trials through post-marketing surveillance — scalable, physician-led, and compliant with FDA, EMA, and global regulatory standards. Click any service card to explore.

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ICSR Management
From receipt to regulatory submission
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  • Receipt & documentation of AEs from all channels (spontaneous, studies, literature)
  • Medically sound case narrative preparation
  • Physician-led causality, seriousness & expectedness assessment
  • Expedited reporting to EudraVigilance, FAERS, and national competent authorities
  • MedDRA coding QC and quality assurance review
  • Follow-up requests and nullification management
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Signal Detection & Evaluation
Proactive surveillance with physician interpretation
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  • Ongoing screening via EVDAS, company safety databases, and literature
  • Signal confirmation and medical evaluation of benefit-risk impact
  • Signal Identification Report (SIR) preparation
  • Regulatory liaison with PRAC and competent authorities
  • Region-specific signal monitoring on request
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Safety Reports
DSUR, PBRER, PSUR, RMP — authored globally
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  • DSUR/PSUR/PBRER per ICH E2C(R2) with cumulative benefit-risk evaluation
  • Risk Management Plan (RMP) preparation and lifecycle maintenance per GVP Module V
  • Ad hoc safety reports for regulatory authority requests
  • Region-specific adaptation and regulatory submission support
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Medical Monitoring
Real-time physician oversight for clinical trials
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  • SAE and SUSAR management with rapid medical review
  • Safety Management Plan (SMP) and Investigator Brochure (IB) authoring
  • Protocol safety review and benefit-risk input
  • DSMB participation and independent medical adjudication
  • Clinical hold / partial hold support and regulatory responses
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QPPV & Regulatory Representation
EU-resident QPPV and global local PV
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  • EU QPPV services under Directive 2001/83/EC — permanently accessible, multilingual
  • EudraVigilance legal representation and Sponsor Profile Registration
  • Local QPPV: UK, South Korea, Australia/APAC, Greater China
  • Local QPPV: MENA, Turkey, Israel, UAE
  • Central and local level oversight with direct competent authority liaison
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Quality & PV Audit Services
Inspection-ready from day one
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  • Gap assessments and simulation audits with CAPA planning and follow-up
  • SOP and Work Instruction development and revision
  • QMS design and implementation per GVP and global requirements
  • Training programs and compliance monitoring
  • Onsite and remote auditing support
Therapeutic Area Expertise

Specialist Depth Across Disease Areas

Our physicians have held senior safety roles at Biogen, Amgen, GSK, BMS, Ipsen, and the NIH. Click a tile to explore our depth.

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Oncology
Dose-escalation safety under FDA Project Optimus; IO, ADCs, targeted therapy, cell & gene therapy; irAE evaluation; DLT definitions and stopping rules; class-effect assessments for TKIs.
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Neurology & Neuropsychiatry
CNS AE evaluation (seizure, cognition, neurobehavioral); suicidality/ideation risk per C-SSRS and FDA guidance; rare neuromuscular programs (DM1, DMD, ALS); movement-disorder signals.
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Immunology, ID & Vaccines
Phase 1 vaccine safety governance; AESI evaluation (myocarditis, GBS, thrombotic events); biodefense programs (COVID-19, Ebola, anthrax, malaria); CRS and immunogenicity-related safety interpretation.
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Rare Disease & Gene Therapy
Safety oversight for ultra-small patient populations; specialized stopping rules for gene therapy programs; safety strategy for viral-vector and RNA platforms; FIH risk-mitigation planning.
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Early Phase / First-in-Human
SAD/MAD oversight with real-time medical monitoring; rapid CRS and infusion-reaction adjudication; safety leadership for novel biologics; safety stopping-criteria development and benefit-risk framework design.
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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 functions; inspection communication support.
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🏆 Our physicians have contributed to global regulatory approvals including Tafinlar, Somatuline, and Inaqovi, and led safety programs at Biogen, Amgen, GSK, BMS, Ipsen, and the US National Cancer Institute.
Pillar 02

ClinRM ExpertConnect

When your safety question requires a clinician who has treated these patients — not just reviewed their charts — ExpertConnect delivers that physician within 48 hours.

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Independent SUSAR Medical Review
Specialist physicians review serious unexpected adverse reactions within 48 hours — providing therapeutic-area clinical depth beyond standard PV generalist assessment.
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Complex Benefit-Risk Consultation
Expert clinical judgment for high-stakes regulatory queries, FDA/EMA safety responses, and benefit-risk reassessments requiring therapeutic-area depth.
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DSMB & Independent Adjudication
Qualified specialist physicians for Data Safety Monitoring Board participation and independent clinical event adjudication across therapeutic areas.
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Investor & Due Diligence Safety Review
Physician-reviewed safety landscape analysis for VCs, PE firms, and acquirers — evaluating product risk profiles, signal history, and regulatory exposure.
"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."
ExpertConnect Leadership
Dr. Narinder Pal Singh
MD, MBA, FACP, FRCP, FASN · Chief Medical Officer, ClinRM ExpertConnect
35+
Years in Internal Medicine & Nephrology
210+
Peer-Reviewed Publications
12+
CKD Trials with Safety Oversight
Request Expert Consultation →
Specialty Services

Medical Affairs & Strategic Support

For lean biotech teams: access the medical affairs capabilities of a large pharma organization — without the headcount. We train on your platform at our own cost before engaging your stakeholders.

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Medical Affairs
Flexible, on-demand medical affairs support tailored for small and emerging biotech organizations — from scientific strategy through KOL engagement and MSL-style outreach.
  • KOL mapping, identification, engagement & advisory boards
  • Patient journey mapping and medical launch planning
  • Scientific communication and publication planning
  • Medical education programs and congress support
  • Medical information support and evidence generation strategy
  • Contract MSL-style engagement; medical team building
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Epidemiology Services
Enterprise-grade epidemiology for startups and biotechs — translating disease burden data into actionable insights for trial design, regulatory discussions, and market positioning.
  • Disease burden and landscape assessments
  • Incidence, prevalence, and patient population estimation
  • Natural history studies and RWD analysis
  • Target population and addressable market sizing
  • Epidemiology input for regulatory, HTA, and clinical development strategy
  • Registry design and observational study support
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Clinical Trial Recruitment
Purpose-built for rare disease, oncology, IO, cell therapy, and gene therapy trials where standard recruitment approaches fall short. Tailored per-site strategies that move the needle.
  • Recruitment strategy development and feasibility assessment
  • Per-site recruitment planning based on investigator and patient realities
  • Clinical site identification, review, and optimization
  • Patient retention strategies and referral network engagement
  • Protocol training for site teams and investigator engagement
Pillars 03 & 04 — Intelligence & Insights

Data-Powered Safety Intelligence

AI-driven surveillance and strategic clinical trial intelligence — giving your team and your investors a validated, real-time view of the safety landscape.

ClinRM Intelligence

AI-Powered Safety Surveillance

Automated pharmacovigilance intelligence and product safety landscape analysis — validated, timely, and structured for decision-making by safety teams and investors alike.

  • AI-powered investor and due diligence safety reports
  • Competitive product signal surveillance
  • Safety landscape analysis for M&A and licensing decisions
  • Emerging signal monitoring across therapeutic classes
ClinRM Insights · ClinicalTrialsDaily.com

Clinical Trial Intelligence

Strategic intelligence on trial activity, site performance, and drug development trends — translating public data into actionable insights for clinical operations and business development.

  • Clinical trial landscape and competitive monitoring
  • Site identification and enrollment performance benchmarking
  • Development program trend analysis
  • Custom intelligence briefings for leadership and boards

Not sure which service fits?

Most clients start with a 20-minute conversation. No commitment. No retainer. Just clarity on how ClinRM can support your safety operations.

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