Historically, pharmacovigilance has been viewed as a time-consuming challenge, suffering from confusion and misalignment on industry approaches regarding regulations, as well as divergence in regulations across global health authorities.
The Interpretation of Pharmacovigilance Regulations Initiative will share expertise to more efficiently and effectively meet the intent of pharmacovigilance requirements that seem ambiguous. The initial focus will be recent measures such as the IND safety reporting requirements, but over time the Initiative hopes to work proactively with health authorities toward modernized and internationally harmonized pharmacovigilance.
This Initiative will benefit patients, sponsors, and regulators through:
- Improved patient safety from a more reliable interpretation of regulations
- Reduced sponsor compliance risks by better understanding of regulations
- Increased efficiencies for regulators because of potential reductions in compliance issues
This Initiative will deliver the following assets and activities:
- Interpretation and implementation best practices catalog for the IND Safety Reporting Regulations
- Framework and process for interpreting and implementing regulations that promote collaboration with and across regulators
- Outreach to regulators regarding initiative intent and interpretation of selected pharmacovigilance regulations
The eSource Initiative seeks to assist TransCelerate Member Companies, and ultimately other trial sponsors in overcoming real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors.
Clinical Data Standards
The Clinical Data Standards Initiative, in collaboration with leading industry organizations, aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.
Risk Based Monitoring
TransCelerate’s Risk Based Monitoring initiative seeks to develop an model approach for risk-based monitoring of clinical trials, with the goal to both enhance patient safety and ensure the quality of clinical data.