While efforts around pharmacovigilance have made substantial progress in the past several decades, the biopharmaceutical industry shares a common set of challenges in drug safety surveillance such as engaging the public, collaborating with regulators, incorporating data and analytics, developing model approaches, and assessing the impact of efforts. As science and technology advances, and patients step into the forefront of their own care, the nature of these challenges have provided new opportunities to reassess areas for improvement.

Our Pharmacovigilance portfolio aims to address some of these challenges using TransCelerate’s collaborative model implemented against our Clinical Portfolio. Please take the time to explore our Initiatives below.

Advancing Safety Analytics

This initiative aims to develop best practices and guidance around the application of interrogative methods towards various safety data sources.

Common Serious Adverse Events (SAE) Fields

The Common Serious Adverse Events (SAE) Fields Initiative intends to conduct a feasibility assessment, develop best practices relating to identifying the most critical SAE fields, and work with an industry standard setting organization to promulgate standards in this area, all with the intent of increasing the quality of what is reported and creating efficiencies for sites, CROs and regulators.

Intelligent Automation Opportunities in Pharmacovigilance

The Intelligent Automation Opportunities in Pharmacovigilance initiative focuses on identifying how intelligent automation technologies can be used to better support execution of Pharmacovigilance activities/processes.

Interpretation of Guidances & Regulations

The Interpretation of Guidances & Regulations Initiative will share expertise to more efficiently and effectively meet the intent of ambiguous regulatory requirements and guidances in both the pharmacovigilance and clinical areas.

Pharmacovigilance Agreements Optimization (PVAO)

The Pharmacovigilance Agreements Optimization Initiative seeks to produce a customizable, interactive resource for new and experienced contract partners, which could be used to inform and/or streamline their PVA process development, contract drafting, and negotiations.

Value of Safety Information Data Sources

The Value of Safety Information Data Sources Initiative will seek to identify sources of safety information for a single high value valid cases and develop a proposed method for aggregate reporting of lower value cases.