Friday 12 May 2017

INDIA - A need to develop our own In house safety database solution

In the recent times we have seen a growing prevalence of diseases and chronic disorders, in order to eradicate life threatening diseases and chronic conditions, we have made one leap forward towards developing an effective pharmacovigilance system, with the sole aim to provide robust patient safety, through monitoring adverse drug reactions, signal detection and risk management plan.

Collection, detection, assessment and monitoring of adverse event through ICSR’s (Individual Case Safety Reports) requires specialized IT framework with the capabilities of Intelligent Automation for computing frequency of adverse events using complex algorithms and statistical disproportions, which will help us then to understand the benefit-risk profile of the drug, paving way for an effective risk management plan.

With PvPI facilitating drug safety activities in India, In the current scenario there is an strong need for collaboration of IT segment with PvPI to build an in house safety solution which will encompass all the capabilities for carrying out end to end pharmacovigilance process and at the same time it should be made available for patient/ healthcare professionals as a cloud based services or android/IOS service for direct reporting of adverse events.

This service could be linked to Aadhar card, where in which a patient or HCP when reporting an adverse event, by simply entering the telephone number or UID will get an OTP on their smartphone and then after providing the OTP, the end user would have complete access to his/her own database which would include the number of previous adverse event reports submitted, current status of reports, this would also enable auto filling of contact details in adverse event monitoring using machine learning.

Brought to you by Think-I - an organization providing technological solutions and result oriented quality services in Pharmacovigilance, Clinical Trials, Medical Writing, Drug Regulatory Affairs and Human Resources.

We provide cloud based software solutions for pharmacovigilance which are not only cost effective and user friendly but also fully validated for quick, easy import, entry and electronic submissions of adverse event.

For more details, refer to product brochure or contact +91 9560102587 or +91 9810068241