Services

Drug Safety

Global Research Services provides full safety reporting for both drugs and medical devices on a 24/7 basis worldwide. Because of our strategic locations in Asia, Europe and North America, we can receive adverse events in a timely fashion from anywhere in the world. We are never more than 6 hours from reporting a Serious Adverse Event to a Sponsor. Our European Safety staff are EVWEB certified and can file Eudra CT applications as well as Sudden Unexpected Serious Adverse Reactions into the EMEA database. GRS performs subject unblinding when necessary for reporting of drug-related and unexpected adverse events to national regulatory authorities. All safety staff can perform regulatory reporting in all countries where we conduct clinical trials. GRS uses Oracle AERS as its safety database for all safety data and provides Sponsors with read-only access at all times. GRS prepares annual safety updates to meet regulatory reporting requirements worldwide. GRS also provides medical monitors and adverse event help-lines as needed to meet project requirements.

In addition to safety reporting for both drugs and medical devices, GRS can also establish and manage both Clinical Events Committees (CECs) and Data Safety Monitoring Boards (DSMBs).

For a CEC, GRS develops the Guidance Document and ensures that this document meets all regulatory standards. GRS assists with selection of committee members, acquires, reviews, assembles clinical endpoints and distributes these to CEC members for continuous adjudication. GRS can also organize face-to-face adjudication as necessary in order to meet project goals and timelines.

For a DSMB, GRS develops the Guidance Document and ensures that this document meets all regulatory standards. GRS assists with Board member selection, organizes the Board meetings, assembles all safety data, and prepares the statistical information required for DSMB review. GRS ensures that results of the meeting are reported to clients in a timely fashion and that DSMB recommendations are implemented as requested.