Clinical Data Management & Pharmacovigilance
Clinical Data Management (CDM) deals with the overall bulk of data obtained from patients in a trial and accounts for the safety and efficacy of the treatment regimen.
This would include patient history, prior treatments, standard of care as well as research procedures, and the process.
The results of same are documented and stored in accordance with GCP and HIPAA policies.
This also includes reporting medically significant events to account for drug safety.
Pharmacovigilance (Pv) is focused on the safety profile of drugs, and effective documentation and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs) according to the regulatory guidelines.
These are unexpected events that may occur outside the predicted nature of effects of the investigational drug. Generally, SAEs are given more importance under Pharmacovigilance as they are harmful to the patient and require proper reporting and follow up.
It is important for an investigator to determine the cause of the SAE and analyze whether it is due to the investigational drug or not.
In cases where an SAE shows a significant link to the investigational drug, FDA reporting is mandatory.
We at Consortium Clinical Research, handle Data Management and Pharmacovigilance for Phase I and Phase II level and have built up necessary resources and infrastructure to meet the Phase III and PMSS requirements.