ABOUT ASTRACLINICAL

Over 25 Years of Scientific Rigor & Clinical Excellence

From our origins as an academic clinical epidemiology group in Montreal to an international full-service CRO managing trials across 28 countries, our mission is to accelerate life-saving cures to market.

Executive Clinical Leadership

25+ Years of Scientific Integrity & Global Compliance

Our multidisciplinary investigators and study directors maintain 100% inspection success across US FDA, Health Canada, and EMA.

OUR STORY & EVOLUTION

A Globally Recognized Canadian-Based Mid-Tier Powerhouse

Over the past decade, AstraClinical has navigated high-volume studies involving over 500,000 patients across 8,500 investigator hospital sites worldwide. We bridge the gap between large multinational biopharma sponsors and specialized academic medical centers.

Unlike massive bureaucratic CROs where mid-sized sponsors are deprioritized, our mid-tier niche positioning ensures direct C-suite oversight, agile protocol amendments, and committed project leadership from Phase I First-in-Human through Phase IV Real-World Evidence.

• Established agreements with top-tier hospitals and research centers worldwide • Pioneers in remote and risk-based monitoring (RBM) methodologies • 100% inspection pass rate across US FDA, EMA, Health Canada, and DCGI
Our success depends on the caliber and scientific integrity of our people. We combine rigorous academic epidemiology with agile operational execution.
Executive Leadership Board AstraClinical Research
SCIENTIFIC GOVERNANCE

Executive Leadership & Medical Direction

Led by internationally recognized epidemiologists, physicians, and regulatory scholars.

Dr. John Sampalis, PhD

President & Chief Scientific Officer

Internationally recognized clinical epidemiologist, professor of surgery and epidemiology with over 300 peer-reviewed medical publications.

Dr. Anshu Patel, MD

Global Medical Director & Head of PV

Board-certified physician with 20+ years steering pharmacovigilance, medical monitoring, and drug safety signaling across US, EU, and Asia.

Dr. Robert Marcil, PhD

VP of Biostatistics & Data Science

Former health authority statistical reviewer, CDISC Platinum contributor, and expert in adaptive Bayesian trial design and SAS modeling.

QUALITY ASSURANCE

Certified Global Compliance Standard

Rigorous quality oversight guaranteed through independent quality assurance (QA) audits.

US FDA 21 CFR Part 11 Validated
ICH-GCP E6(R2) Standard of Care
EMA & MHRA European Directives
CDISC SDTM & ADaM Platinum
ISO 9001:2015 Quality Management
HIPAA & GDPR Data Privacy Guard
Study Proposal Received

Our Medical Review Team will contact you under NDA within 24 hours.