INTERNATIONAL FOOTPRINT

Global Reach with Uncompromised Regional Agility

Operating across 28 countries, our regional operating units combine deep local regulatory relationships, rapid investigator recruitment, and harmonized global ICH-GCP standard operating procedures.

28
Countries Served
8,500+
Active Site Network
500K+
Patients Recruited
6
Primary Corporate Hubs
REGIONAL HUBS & OPERATIONS

Strategically Situated Across Key Regulatory Jurisdictions

Whether executing IND submissions in the United States, CTA filings under EU CTR 536/2014, or high-volume patient recruitment across Latin America and APAC, our hubs provide native-speaking teams and direct institutional access.

Global Clinical Monitoring Network

Harmonized Multi-Country Trial Monitoring

Unified SOPs, real-time risk-based monitoring (RBM), and bilingual clinical monitors operating across all 28 regulatory zones.

Global Headquarters

Montreal, Canada

CA HQ

4492 Sainte-Catherine St W, Suite 400
Westmount, QC H3Z 1R7, Canada

Direct Phone: +1 (514) 934-0805

Key Strengths: Phase I–IV Clinical Operations, Biostatistics, Epidemiology

Primary Agency: Health Canada (TPD / BGTD)

North America Commercial Hub

Boston & San Diego, USA

USA

Cambridge Innovation Hub & Torrey Pines BioPark
Boston, MA & San Diego, CA, USA

Direct Phone: +1 (617) 849-9319

Key Strengths: US FDA Pre-IND Meetings, Biotech Clinical Programs

Primary Agency: US FDA (CDER / CBER / CDRH)

UK & Northern Europe Hub

London, United Kingdom

UK

25 Bank Street, Canary Wharf
London E14 5JP, United Kingdom

Direct Phone: +44 20 7946 0912

Key Strengths: MHRA Submissions, NHS Hospital Site Management

Primary Agency: MHRA & HRA

Central & Eastern Europe Hub

Warsaw, Poland

EU

Al. Jerozolimskie 142B, Blue City
02-305 Warsaw, Poland

Direct Phone: +48 22 584 7200

Key Strengths: Fast Patient Enrollment, EU CTIS Submissions

Primary Agency: EMA / URPL

APAC Pharmacovigilance & Data Hub

Mumbai & Faridabad, India

APAC

AstraClinical Center of Excellence, Corporate Zone
Navi Mumbai & Faridabad, India

Direct Phone: +91 7738804988

Key Strengths: End-to-End Safety/PV, Medical Writing, CDISC Data Mgmt

Primary Agency: CDSCO / US FDA Global

Latin America Operational Center

Bogotá, Colombia

LATAM

Carrera 7 #116-50, Torre Cencosud
Bogotá, Colombia

Direct Phone: +57 1 744 3820

Key Strengths: LATAM Multi-Country Monitoring, High Retention Rates

Primary Agency: INVIMA / ANVISA

REGULATORY BENCHMARKS

Average Trial Startup & Ethics Approval Timelines

We leverage local institutional relationships to dramatically compress regulatory lead times.

Region / Country Regulatory Authority Ethics (IRB/EC) Review Startup to First Patient Local AstraClinical Hub Support
Canada Health Canada (TPD) 30 Days (CTA Default) 8–10 Weeks Montreal HQ Direct
United States US FDA (IND) Central IRB: 1–2 Weeks 6–8 Weeks Boston / San Diego Hub
European Union (Poland) EU CTIS / URPL Harmonized CTIS (Part I & II) 10–12 Weeks Warsaw EU Center
India CDSCO (SUGAM) Parallel Institutional EC 10–14 Weeks AstraClinical Mumbai & Faridabad
Colombia & LATAM INVIMA / CEC Independent Ethics: 4–6 Wks 12–14 Weeks Bogotá LATAM Team

Planning a Multi-Country Clinical Trial?

Connect with our International Study Planning Directorate for country feasibility reports and patient enrollment projections.

Study Proposal Received

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