RWD and RWE in regulatory decision-making

As many medicines regulatory agencies have expressed increased willingness to consider RWE to support claims of efficacy or effectiveness as well as of safety, the data and methods used to generate RWE are changing. To assist those responsible for generating or interpreting RWE, the Council for International Organizations of Medical Sciences (CIOMS) has just published a consensus report on “Real-world data and real-world evidence in regulatory decision-making”.
HealThink is committed to providing RWE services in compliance with the Guidelines for Good Clinical Practice (ICH-GSP), the CIOMS International Ethical Guidelines for Health and Human Research, and all applicable regulations and guidelines. Therefore, it is our duty to be constantly informed and educated in order to be a reliable partner to our customers.