Insights and guidance to address patient safety through all stages of clinical research
This whitepaper provides an overview of the Pharmacovigilance System Master File (PSMF) and how it has evolved over the last ten years, both inside and outside of the European Union.
Read the whitepaperThis whitepaper explores the benefits in adopting an outsourced model for pharmacovigilance that is centrally managed and geographically dispersed, ensuring efficient and compliant delivery whilst retaining the effectiveness of a local presence.
Read the whitepaperOur solution ensures compliance through automation. Based on an innovative cloud-based system and featuring automated and configurable business rules, it enables you to gain visibility into the safety profile of an investigational product throughout its lifecycle.
Read the whitepaperJapan is the third-largest consumer of ethical drugs and the world’s third-largest economy; therefore, it is an important development centre for new medicines.
LATAM is evolving to electronic safety reporting and it is essential to be prepared for it.
FDA has upgrade the Investigational New Drug (IND) safety reporting from paper eCTD format to E2B format, improving potential safety signals in clinical studies.
COVID-19 disrupted clinical trials across all indications. Patient enrolment, participation, data collection, and more was forced to adapt to the challenges of this virus.
As procedures typically carried out on-site continue to be managed remotely, sponsors will need to implement a remote clinical trial management strategy to mitigate further roadblocks that may arise and keep clinical trials moving forward.
COVID-19 is affecting how clinical trials are managed, in terms of patient recruitment, patient care, data collection, analysis and safety reporting.
Shradha Galaya, Director of Global Safety Regulatory Reporting, reports on the highlights of her recent virtual attendance at DIA Europe 2021.