Patient Safety and Pharmacovigilance
Insights and guidance to address patient safety through all stages of clinical research
As global regulatory frameworks evolve our pharmacovigilance and drug safety teams can guide clients to understand and address the latest updates to identify, evaluate, and manage risk throughout the drug and device development process.
Pharmacovigilance Affiliate Model: Why outsourcing makes sense at an affiliate level
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 whitepaperUnderstanding the Periodic Benefit-Risk Evaluation Report
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 whitepaperSponsor and CRO pharmacovigilance and safety alliances
This whitepaper outlines the best practices and model options for ensuring success when outsourcing pharmacovigilance and patient safety services.
Read the whitepaperEvolution of the Pharmacovigilance System Master File
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 whitepaperTaking safety reporting to the next level with automation
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 whitepaperPatient safety and pharmacovigilance blogs and media contributions
Blog: How joint venture models can boost Japan’s pharmaceutical industry
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.
Blog: Safety reporting in LATAM is changing, are you ready?
LATAM is evolving to electronic safety reporting and it is essential to be prepared for it.
Blog: Changes in clinical safety reporting to the FDA
FDA has upgrade the Investigational New Drug (IND) safety reporting from paper eCTD format to E2B format, improving potential safety signals in clinical studies.
Blog: Data disruption: Navigating cardiovascular clinical trial adjudication during a respiratory pandemic
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.
Blog: Remote management: The new normal in a post-COVID world
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.
Blog: The impact of COVID-19 on pharmacovigilance
COVID-19 is affecting how clinical trials are managed, in terms of patient recruitment, patient care, data collection, analysis and safety reporting.
Blog: Event report - DIA Europe 2021: Advancing health priorities
Shradha Galaya, Director of Global Safety Regulatory Reporting, reports on the highlights of her recent virtual attendance at DIA Europe 2021.