Strategic Pharmacovigilance and Pharmacoepidemiology Consulting.
Decisive, evidence-based safety leadership to protect patient health, satisfy global regulators, and safeguard your clinical asse
Navigating complex drug safety signals, post-authorisation mandates, and benefit-risk determinations demands more than standard operational processing, it requires world-renowned epidemiological authority. Professor Shakir provides sovereign strategic counsel and end-to-end study execution for pharmaceutical sponsors facing critical regulatory inflection points.
The High Cost of Uncertainty in Clinical Safety and Surveillance
In drug development and commercialisation, safety issues rarely arrive with convenient timelines. An unexpected cluster of adverse events during Phase III, an ambiguous post-marketing signal, or an urgent inquiry from the EMA, FDA, or MHRA can threaten an entire program.
Internal safety teams are frequently stretched thin by routine operational casework, leaving little bandwidth for the advanced methodological rigor required to resolve complex safety queries. When regulatory authorities demand a Post-Authorisation Safety Study (PASS) or question your product’s benefit-risk profile, generic compliance protocols are not enough. Relying on improper data sources, ambiguous study designs, or weak statistical controls can trigger clinical holds, severe label restrictions, or unnecessary market withdrawals.
To satisfy regulatory bodies and protect public health, you need senior scientific judgment that has defended products through every modern safety challenge.
Scientific Rigor Meets Boardroom Strategy
Professor Shakir approaches pharmacovigilance not as a transactional reporting checklist, but as an applied science that underpins your asset’s therapeutic and commercial viability.
By integrating decades of frontline pharmacoepidemiology with high-level regulatory strategy, our advisory practice bridges the gap between intricate statistical analysis and global health authority requirements. Whether translating an emergent signal into a structured, regulator-approved research question or running sophisticated quantitative benefit-risk modelling, every recommendation is engineered to provide scientific clarity and regulatory certainty.
You gain an objective, world-respected principal investigator and strategic partner who steps directly into high-stakes environments to guide sponsors from vulnerability to definitive resolution.
Core Capabilities Across the Product Lifecycle
From early clinical trials to long-term post-marketing surveillance, we deliver bespoke scientific oversight across four critical domains.
Pre-Marketing Safety Evaluation & Clinical Development
Trial Safety Architecture: Comprehensive evaluation of safety data generated throughout clinical development programs.
Benefit-Risk Characterisation: Early-phase benefit-risk profiling using conventional qualitative assessments alongside formal quantitative frameworks to support New Drug Applications (NDA) and Marketing Authorisation Applications (MAA).
Adverse Event Investigation: Specialized assessment of individual and clustered Adverse Drug Reactions (ADRs) to clarify mechanism, causality, and clinical impact before phase advancement.
Strategic Post-Marketing Surveillance & Crisis Management
Signal Detection & Triage: Deep evaluation of post-marketing signals to separate genuine safety issues from clinical noise and reporting artefacts.
Crisis Navigation: Strategic leadership during critical regulatory junctures, including defending indications, negotiating Risk Minimisation Measures (RMMs), and mitigating product withdrawal risks.
Label Restrictions & Patient Populations: Methodological support to define safe therapeutic parameters, refine contraindications, and manage limitations for vulnerable cohorts.
Pharmacoepidemiological Research & Real-World Evidence
Post-Authorisation Safety Studies (PASS): Complete scientific direction for both voluntary and regulatory-mandated PASS commitments.
Registry Development & Management: Design and oversight of prospective disease and product registries to monitor long-term outcomes and rare adverse events.
Drug Utilisation Studies (DUS): Robust evaluation of prescribing behaviors, off-label use patterns, and commercial adherence across major healthcare databases.
Effectiveness of Risk Minimisation: Objective measurement protocols to demonstrate whether educational materials, controlled distribution systems, and warnings are working as intended.
Quantitative Benefit-Risk Modelling
Multi-criteria decision analyses (MCDA) and structured quantitative frameworks that clearly articulate the therapeutic balance to health authority advisory panels and reimbursement bodies.
A Transparent, End-to-End Methodological Process
ngagements are configured to your operational needs, whether acting as an external peer-reviewer for an internal team or serving as the full Principal Investigator for a global study.
Safety Challenge Deconstruction
We begin by translating your regulatory notice, emerging signal, or clinical safety concern into an actionable, scientifically sound research question.
Data Sourcing & Partner Selection
We evaluate and identify the optimal healthcare database, registry, or cohort (e.g., CPRD, IQVIA, national registers) and select the most qualified operational service providers.
Protocol Formulation & SAP Design
Professor Shakir directs the authoring of the comprehensive study protocol, anticipating regulatory scrutiny, eliminating confounding variables, and supervising the Statistical Analysis Plan (SAP).
Active Oversight & Study Conduct
We monitor scientific execution throughout data collection and extraction, ensuring methodological compliance and resolving emergent analytical hurdles in real time.
Final Reporting & Regulatory Presentation
We oversee the drafting of the final study report, ensuring the conclusions are scientifically sound, clearly articulated, and defensible before global regulatory bodies.
Unrivalled Global Authority and Proven Track Record
Regulatory agencies rely on demonstrated competence and methodological integrity. Professor Shakir brings a level of credibility that immediately shifts the tone of regulatory interactions.
Frequently Asked Questions
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Critical safety issues often demand immediate triage. For acute regulatory deadlines, such as an unexpected safety inquiry, imminent label action, or an urgent PRAC/CHMP question, initial strategic evaluations can be coordinated within days. We assess the available data, define immediate remediation steps, and outline the defensive scientific strategy required for regulatory engagement.
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Engagements are entirely modular. Professor Shakir frequently operates as an executive peer consultant, reviewing draft protocols, auditing benefit-risk documents, or offering targeted advice on a complex signal. For sponsors requiring complete external governance, he can assume full scientific leadership as Principal Investigator, managing the project from protocol design through final study delivery.
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Selection depends on the specific research question, therapeutic area, and product exposure. Professor Shakir maintains deep, vendor-independent expertise across primary European and North American healthcare utilization databases, electronic health records, and bespoke national registries. The optimal data environment is selected strictly on its statistical validity, linkage capabilities, and regulatory acceptability.
Initiate a Confidential Advisory Discussion
Contact Prof. Saad Shakir directly to discuss your pre-marketing safety profile, post-marketing surveillance strategy, or upcoming PASS mandate.