The Nuts and Bolts of Safety Reporting - the Role of the CRO
Dr. Noa Lowenton Spier, D.V.M
Project Manager
Pharma Clinical S.A.G.
The importance of generating a safety profile of drugs is unquestionable. An effective
system for reporting AEs during the development of an investigational drug is necessary to
ensure an objective assessment of the risk/benefit profile of a drug. In order to construct a
precise safety profile, the quality and accuracy of the information reported by the
investigator is crucial.
Inaccurate data will always lead to inaccurate conclusions.
Safety reporting presents many challenges that not always meet the eye. Day to day
practice of the medical doctor treating a patient is different from the required practice for
conducting a clinical trial. Does the investigator really know how to communicate to the
sponsor the information in a way that reflects the course of the event? Is he/she provided
with sufficient tools to support clinical judgment and case assessment? His first assessment
may balance the tip for an expedited reporting.
The CRO takes a critical role by assisting the investigator in facing these challenges and by
verifying that the data reported is accurate and reliable.
Dr. Noa Lowenton Spier, D.V.M, is a project manager at one of Israel's leading CROs
Pharmaclinical S.A.G (2003) Ltd. Prior to her current position; she held the positions of the
local drug safety manager of Bayer in Israel and of a CRA. Before joining Pharmaclinical
S.A.G (2003) Ltd., Noa practiced veterinary medicine. Noa is a graduate of The Koret
School of Veterinary Medicine at the Hebrew University of Jerusalem