CRO SERVICES · PHARMACOVIGILANCE · CLINICAL CONSULTING · SOURCING SOLUTIONS

Physician-Led Clinical Development and Pharmacovigilance

Alpha Clinical Development is a boutique, physician-led CRO delivering ICH-GCP-compliant clinical trial management and end-to-end pharmacovigilance for pharmaceutical and biotechnology sponsors. From first-in-human studies through late-stage development, regulatory submission and post-marketing safety surveillance, the same senior team stays accountable for your programme from scope to delivery.

Our Clients

WHAT WE DO

Four business units. One physician-led team you can actually reach.

Most sponsors end up managing separate vendors for trial operations, drug safety, regulatory strategy and clinical staffing, then spend half their time keeping those vendors aligned. Alpha runs all four under one roof instead, with the same senior, GCP-trained leads involved from scoping through final delivery — fewer handoffs, fewer repeated conversations, and a team with enough programme context to flag a risk before it becomes one.

CRO Services

Full-lifecycle, end-to-end clinical trial management, including site management, clinical operations, data management and biostatistics. Deep therapeutic focus in oncology, immunology and rare disease, covering the development pathway from first-in-human through late-stage development and commercialisation.

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Pharmacovigilance

End-to-end pharmacovigilance operational and strategic support, spanning ICSR case processing, signal detection, aggregate safety reporting (DSURs, PSURs and PBRERs) and benefit-risk assessment. Global regulatory submissions support, backed by a global network for local PV activities.

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Consulting

Regulatory and clinical strategy to support study concept and design, ensuring right-first-time decisions that support regulatory approval.

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Sourcing Solutions

An executive global network of clinical, regulatory and pharmacovigilance subject-matter experts, supporting operational, technical and strategic activities across short-term, mid-term and long-term resourcing requirements.

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Pharma & Biotech Sponsors Served

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Countries Covered

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Clinical & Safety Experts

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Years of Clinical Expertise

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ALPHA LEADERSHIP

Physician-led. Accountable from scoping to delivery.

Every Alpha engagement is led by physicians and industry veterans who stay hands-on for the life of the programme — not handed off to junior staff once the contract is signed.

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Adnan Mahmood, MD

CEO, Head of Safety, Regulatory Affairs & Quality Assurance

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Ridhwaan Jhetam, MD, MBA

Chief Medical Officer, Head of Clinical Development & Medical Affairs

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Khalid Malik, MD

APAC Clinical Lead

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Haroon Hashmi, MD

SVP and Chief Regulatory Advisor

Global presence

A Global Footprint for Multi-Region Regulatory Delivery

Four offices, one connected team. Alpha supports clinical trials and pharmacovigilance programmes across North America, Europe, the Middle East and Asia-Pacific — aligning study conduct and safety reporting with FDA, EMA, MHRA and regional health-authority requirements.

Headquarters
Cambridge, MA
United States
HQ
Europe
Wokingham
United Kingdom
North America
Mississauga
Canada
Middle East
Dubai
United Arab Emirates

“

Alpha's team brought senior-level oversight to every stage of our programme, from protocol design through safety reporting. Their responsiveness and scientific depth gave us confidence at every milestone.

VP Clinical Development, Emerging Biotech Sponsor

NEWS & INSIGHTS