Newsletter | June 13, 2019

06.13.19 -- The Role Of Real World Evidence In Clinical Research

Bringing Real World Evidence Into Clinical Research

Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.This article explores three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.

5 Reasons Why Pharma Needs A Pharmacovigilance Partner

Are you finding that developing the right systems and SOPs to support long-term pharmacovigilance activities is time consuming and costly? Realize how collaborating with an external partner for these services alleviate this burden along with other added benefits.

The Top 5 Questions To Ask When Developing A REMS

A REMS should be considered when risk mitigation efforts are required beyond product labeling and routine pharmacovigilance. Unsure if a REMS is needed during product development? This article will answer that question and give guidance if implementing a REMS is necessary.

Risk Evaluation And Mitigation Strategy (REMS) Overview

UBC’s Natalie O’Donnell, Executive Director, SERRM, provides a Risk Evaluation and Mitigation Strategy (REMS) overview. Learn more about the importance in partnering with an experienced REMS team for your next study.

The Value Of RWD In Safety Signal Refinement

Population-based RWD are increasingly used by U.S. and EU regulators to complement passive safety surveillance that is based on review of adverse event spontaneous reports. The presentation focuses on a recommended analytic approach for safety scientists, epidemiologists, and other researchers for evaluating the causality of a signal identified from one or more data sources.