Clinical Research · Regulatory · Market Access
Clinvera supports biotech, pharma, and medical-device teams across the full product lifecycle — from first-in-human study design to reimbursement and payer negotiation, pairing academic rigour with real-world experience.
Across all therapeutic areas — with particular depth in oncology, autoimmune disease, infectious disease, surgery, obesity, and vaccines.
What we do
We work with biotechs, pharmaceutical and medical-device companies, research groups, academics, and investors — global for evidence generation, North American for regulatory and reimbursement, with particular depth in Canada.
Protocols for clinical trials and observational studies across all therapeutic areas — from research question and endpoint selection through sample-size determination and CTA/IND submission.
Full-service biostatistics for clinical trials and observational research, from study planning through final analysis and publication-ready reporting.
The full spectrum of medical and scientific writing, managed from initial drafts through journal submission and acceptance.
The full range of clinical and regulatory documents required across the product lifecycle, prepared to ICH-GCP and applicable regulatory standards.
Canada’s payer landscape is fragmented across public and private plans and ten provinces. We help you navigate it to optimize reimbursement and access.
Economic models that translate clinical and real-world evidence into quantified value demonstrations for reimbursement decision-making.
The full value story across clinical, economic, and patient perspectives, tailored for reimbursement stakeholders in the US and Canada.
Every drug has a visible list price and a confidential net price. Through experienced negotiation professionals we help you develop and execute pricing and reimbursement strategy across North American payers.
Pharmacovigilance and drug-safety services overseen by our Canadian-licensed physician, with risk and safety studies across the product lifecycle.
The journey
We’re with you at every step — the same team carrying your evidence strategy from early development through commercialization.
Protocols for clinical trials and observational studies across all therapeutic areas.
Full biostatistical analysis from planning through publication-ready outputs.
Peer-reviewed papers, clinical study reports, conference materials, and regulatory documents.
Submissions to Health Canada, the FDA, and the EMA to authorize your product.
Health economic models and value dossiers that demonstrate your product’s worth to payers.
Navigate public and private payer systems to get your product covered and accessible.
Market-access strategy, payer negotiation, or support in finding a partner for your asset.
From first-in-human protocol design through post-market evidence and payer negotiation — coordinated end to end, not handed between vendors.
How we do it
Clinvera provides study conception, data analysis, medical writing, and publication support — extended by market-access strategy, reimbursement submissions, payer negotiation, and asset-transaction advisory across buy- and sell-side due diligence.
Our work is backed by decades of experience and hundreds of peer-reviewed publications, combining academic depth with the practical judgment that moves programs forward.
Our expertise
Led by a PhD clinical epidemiologist with deep biostatistical expertise.
Tenured professor of medicine across three universities — 30+ years in academia and industry.
Leadership that built and scaled a full-scope, multinational CRO operating in 25+ countries.
Peer reviewers for leading journals including JAMA and BMJ, and for the CIHR College of Reviewers.
Advisors to national and regional health ministries on policy and health systems.
Hands-on experience with FDA, EMA, and Health Canada submissions and approvals.
Specialists across clinical, analytical, economic, and access disciplines.
Let’s talk
Whether you’re designing a first-in-human study or preparing for reimbursement, we’d be glad to help you plan the evidence that gets you there.