WHAT WE DO — CONSULTING

Consulting: Strategic Clinical Planning & Global Trial Execution

Alpha’s Consulting unit provides strategic clinical planning and global trial execution across every phase of development, reducing regulatory risk at every stage. This is senior-level strategic input, not a documentation service — brought in early enough that a wrong protocol, endpoint or regulatory-pathway decision never has the chance to compound into a submission problem.

Led by Adnan Mahmood, Director, Clinical Development & Pharmacovigilance

Capabilities

Capabilities at a Glance

PHASES COVERED

STRATEGIC PLANNING & EXECUTION

SOURCING STRATEGY INPUT

In practice

What This Means in Practice

Trial and protocol design decisions are made with regulatory strategy in the room from day one, not consulted after the fact — endpoints, population selection and study design are shaped to be statistically sound, operationally deliverable and regulatorily defensible at the same time. Clinical oversight continues through execution, not just at the design stage, and regulatory strategy spans global pathway planning, health authority engagement, and — where relevant — accelerated pathway routes such as orphan drug designation, Breakthrough Therapy Designation and PRIME.

Medical consulting expertise extends into sourcing strategy: helping sponsors think through their clinical, pharmacovigilance, regulatory and medical staffing needs as part of the same strategic conversation, rather than treating resourcing as a separate downstream decision disconnected from the development plan.

Why Alpha

Why Sponsors Choose Alpha for Strategy

Physician and regulatory input arrives at the earliest planning stage, grounded in what Alpha’s own CRO and PV teams know can actually be delivered and monitored operationally — not strategy written in isolation from execution reality. With 18+ years of applied regulatory and clinical strategy experience across early phase through real-world evidence generation, Alpha brings a genuinely integrated view: the same organisation that designs the strategy can also deliver the trial and manage the safety programme behind it.

Years of Expertise

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Insights