Safety Database Partner

Literature Search Services
Literature articles /abstract screening which provides new significant information related to safety and efficacy of the drugs forms the important part of an Aggregate report preparation and also provides the vital information to detect a new signal.
The aim of literature screening is to identify Individual Case Safety Reports (ICSR) and/or any new significant information from safety and efficacy studies (clinical, non-clinical and epidemiological) which is not covered by the current product labelling, and/or any variation from the known safety information on the product label by increase in the frequency of an already known adverse reaction or change in severity or specificity of an event or any safety information which is not consistent with the product label.
Our service will include thorough searching (PubMed, Medline, Embase, Toxline, INIST or ARPI) collection, review, selection, documentation, Case registration, performing translation; and generating automated reports of records (weekly, monthly, annual and customized) updating on required GxP safety data base and archiving and ordering of required literatures retrieved from global literature database or local scientific journals.

We shall provide the services as specified below:

  • Each literature article/abstract will be reviewed for identification of ICSRs and other safety concerns.
  • Selection of articles for ICSRs shall be based on the above point and the possibility that event may be attributed with use of the suspected medicinal product. This may not always be apparent in the authors’ text but should be judged while reviewing the article. At least one causal relationship of drug with event should be indicated by author.
  • After selecting the literature article/ abstract as an ICSR attempt will be made and case will be registered on the applicable GxP compliant software and if require full article shall be ordered for the complete evaluation of case report.
  • Any data which is not an ICSR, but contains significant new safety information from safety or efficacy studies (clinical, non-clinical and epidemiological) that is not already covered by the current product labelling shall be selected as an article of special interest for the aggregate report.
  • All the required information related to the validity, invalidity or pending status in the applicable abstract/article for ICSR and PSUR will be updated in the GxP validated database.
  • An EXCEL for the daily repository will be shared on daily basis and maintained for the above mentioned tasks.

    Looking forward to hear from you and assuring you the best of services at all times.


For more information,
please call +91 98100 68241 or Email :bd@thinki.in

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