Insights and guidance to address patient safety through all stages of clinical research
In this whitepaper, we consider the benefits of 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. We also explore the current challenges associated with managing local affiliate pharmacovigilance activities and potential ways to overcome these.Read the whitepaper
How careful preparation of the initial PBRER sets up future success
The International Conference of Harmonization ICH-E2C (R2) requires all license holders of new medicinal products to submit a Periodic Benefit-Risk Evaluation Report (PBRER). Gain insight about best practices that can be implemented during the process of creating an initial PBRER.Read the whitepaper
This whitepaper outlines the best practices and model options for ensuring success when outsourcing pharmacovigilance and patient safety services.Read the whitepaper
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 whitepaper
Our 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 whitepaper
Japan 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.