Literature Monitoring
Importance of Literature Review and its Impact on Risk-Benefit Balance
The safety profile including risk-benefit balance of medicinal products can be monitored through medical literature because it is a significant source of information, particularly the detection of new safety signals or emerging safety issues.
Frequency of Literature Review and its Local Requirement
Therefore, regulators recommend Marketing Authorisation Holder (MAH) to conduct systematic literature review of widely used reference databases [e.g. PubMed, Embase (per client selection), MEDLINE, Cochrane Library, AdisInsight Safety etc. ] with frequency of at least once a week.
Additionally, it is an expectation from authorities to have procedures in place to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorisation.
Our Solution for Complete Literature Monitoring Activity
- Defining search strategy
- Medical literature monitoring
- Local literature screening as per local regulations
- Procurement and review of full text articles where applicable
- Translation of literature articles by certified translators
Given the weekly frequency to perform the literature monitoring activity, it is essential to partner with a reliable service provider like AllyWorth to ensure the optimal regulatory compliance.