NOVO PROVIGILANCE provides medical literature monitoring services by use of globally accepted and validated literature search engines, identifying valid ICSRs and processing them for continuous evaluation of product safety profile for analyzing benefit/risk ratio. We are committed to provide a robust literature monitoring process and practice for the activity.
Global literature monitoring is performed on a weekly and or biweekly basis as per client requirement. Literature monitoring is performed as per the product schedule.
Preliminary assessment is done for all of the listed literature articles and or abstracts to identify the valid individual case safety reports. Any abstracts or articles require translation to English language and full text is procured.
Medical reviewers shall review the preliminary output and conclude whether the abstract or article is ICSR relevant or should be discussed and analyzed for safety and efficacy.