IntelliBuddies® and Pharmacovigilance
RPA and Pharmacovigilance
Pharmacovigilance, also known as drug safety, involves collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. These effects are reported as a part of adverse event reporting. Such reports can come directly from patients or through health providers via agreement with Pharmaceutical companies. Pharmacovigilance involves compliance with elaborate processes such as ascertaining validity of Individual Case Safety Report (ICSR), codification using standardized medical coding dictionary like MedDRA , compiling and submitting reports to regulators to quote a few.
IntelliBuddies® in Action
- ICSR submissions
There are two ways ICSR submissions can be done, via database to database transfer or via website of the regulator. In so far as transfers done via database connections, data needs to be in a specific format required by regulators. IntelliBuddies® contains many out-of-the-box connectors capable of connecting to various data sources including most popular databases, file servers and popular file types such as excel and csv. These connectors can be used by health providers to transfer data to regulators’ database in conjunction with format conversion controls. Buddies can be configured to handle expedited, clinical trial, spontaneous and aggregate reporting required as per regulatory norms.
- ICSR recording
Upon receiving ISCR report from individuals or through field agents, Buddies powered by IntelliBuddies® can gather data from reports using OCR technology and convert it to machine readable format. It can then utilise built-in AI capabilities of IntelliBuddies® to codify reports per medical coding dictionary thus saving time and avoiding errors