Signal Management

COD team is having the competency to execute signal management activities including tool based/ qualitative detection, validation, analysis and prioritization, signal assessment and recommendation for action. Our signal management review includes 04 different periods of safety data review including cumulative safety data by experienced drug safety personnel/physicians. Our team provides support in safety management team meetings, wherein decision-making tree drawings are supported. Considering ourselves as writing experts, we naturally supports for signal evaluation and assessment report writing. The process can be customized and tailor made to match the client’s requirement. • Signal Detection & Validation (Qualitative and Quantitative) output reviews • Signal Evaluation Report Preparation & SME Review • Expert Support for Larger Database Reviews (FAERS, EVDAS, MedEffect) • Handling of Regulatory recommendation and prioritization such as PRAC, CmDH, CHMP