Pharmacovigilance: Standalone or Fully Integrated Safety Solutions

Alpha Clinical Development delivers standalone and fully integrated pharmacovigilance solutions supporting compliant, accurate clinical trial and post-marketing surveillance across the globe — protecting both patient safety and asset value. Every process is aligned to ICH, FDA and EMA requirements as the baseline, with physician-led review built into case handling rather than added as a final compliance check.

Led by Dr. Steffen W. Ernst, Strategic Advisor, Translational Safety — nearly 30 years in pharma safety

Capabilities

Capabilities at a Glance

CASE PROCESSING & REGULATORY REPORTING

SIGNAL & RISK MANAGEMENT

AGGREGATE REPORTING

AUDITS, ADJUDICATION & SURVEILLANCE

In practice

What This Means in Practice

Case processing runs on MedDRA coding, expert medical review and narrative writing, so a case file reads as a clinical picture, not just a compliance record — every case is reviewed by staff with genuine clinical and safety-science backgrounds, which matters most exactly when a case is ambiguous. Signal detection pairs advanced safety analytics with proactive evaluation, translated into concrete risk management strategy rather than a dashboard nobody acts on.

Aggregate safety reporting — DSURs, PSURs and PBRERs — is treated as scientific synthesis, not data compilation: every report is expected to say something meaningful about how a product’s benefit-risk profile is evolving. PV audits and gap analysis give sponsors an honest, physician-informed view of system maturity well before a regulator asks the same questions, backed by CAPA development where gaps are found. Physician-led safety adjudication and translational patient safety advice bring genuine clinical judgement to endpoint and safety-event review, and scientific literature surveillance keeps externally published safety data folded into the product’s risk profile as quickly as internally generated case data.

Why Alpha

Why Sponsors Choose Alpha for PV

Pharmacovigilance is where Alpha began, and it remains the deepest bench of expertise in the business — a global footprint spanning 30+ countries, physician-led case review rather than script-following data processing, and an emerging AI-enabled signal detection capability through our Nexomic partnership that pairs innovation with the human clinical judgement regulators still expect. Because Alpha’s safety team sits inside the same organisation as clinical development and regulatory strategy, PV is never a disconnected compliance function bolted onto a study after the fact.

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