The Revolution in Pharmacovigilance
GK PV Zoom understands that Medical Information is the frontline between our clients and their customers.
Our strategy is flexible to your needs and, with input, we are able to tailor our service delivery to mirror your culture — safeguarding your company’s values and your customers’ expectations.
Functionality
Combination, detection, evaluation, monitoring, and prevention of adverse effects with pharmaceutical products then ICSRS recording system according to ICH-E2B R3 international guidelines.
Pharmacovigilance
Risk Assessment
by providing data from clinical practice available in electronic health records or prescription databases.
Operation of pharmacovigilance
General Approach
The company PV Zoom team is only responsible to operate PV Zoom during the contract period as Entering data & Generating XML file to be sent to National Health Authority.
PV Zoom can track different types of reports to be sent to regulatory Authorities:
Individual Case Safety Reports (ICSRs) in XML format divided into:
-Initial ICSR
-Follow up ICSR
Literature review report with different search options.
Security
PV Zoom Flow will be accessed by QPPV/PV personal through user name & password & we can make restriction access for other users.
In case there are more than one company related to the same owners or that is related somehow in business, PV Zoom can provide specific access to each company.
Their fitness for purpose
PV Zoom provides tool to record unlimited ICSRs received either spontaneously or non- spontaneously & allows company Zoom team to case seriousness, patient details, reporter, ADR detected and company suspected product.
Creating guidelines
Allow PV Personnel to generate more than version to the same case in case of follow up or new data regarding the same case collected.
PV Zoom generate XML file according to ICH-E2B R3 guidelines that can be received by national authority & imported to their database directly.