Literature Screening

The review of scientific and medical literature is an essential exercise and source of information for the safety profile of medicinal products, especially in the detection of new safety signals or emerging safety issues (ESIs).

 

To ensure compliance with regulatory legislation worldwide it is vital that global and local literature screenings are conducted routinely. It is necessary to identify reportable Individual Case Safety Reports (ICSRs) and detect new safety signals for emerging safety issues if they exist.

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Our experienced team at Gemini Group can support you with all of these activities to ensure your pharmacovigilance (PV) program adheres to the global regulatory requirements.

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What is the Difference Between Global and Local (non-indexed) Literature Screening?

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Global literature screening is an activity that needs to be implemented consistently in large biomedical databases that comprise the majority of scientific and medical journals. Articles retrieved during global literature searches can be written in any language.

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Local Literature Screening (LLS) is performed by screening journals which are not included in biomedical databases used during global literature screening. Those journals are considered to be non-indexed literature. Some countries have specialized local databases that help moderate the process of journal selection.

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Wide Range of Postmarketing Services

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Gemini Group’s comprehensive suite of services ensures you meet all your PV responsibilities.

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Our services are cost-effective and we are able to conduct global literature surveillance.

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Global Literature Monitoring Team can help you with:

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• Selecting global biomedical databases to be used during Global Literature Screening (e.g., Medline, PubMed, Embase)

• Developing unique search strategies which will be used for every single medicinal product

• Systematically monitoring these databases for publications worldwide

• Agreeing on the frequency of the searches

• Record keeping – retaining the results from literature searches for an appropriate period.

• Understanding and complying with the time deadlines that apply to Individual Case Safety Reports from Literature Screening.

• Avoiding duplicate reporting of ICSRs from literature

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We have extensive experience in developing vigorous search strategies for our clients and deliver results from these searches according to an agreed periodicity.

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We help with the review and evaluation of identified literature articles, ensure the efficient and auditable documentation of results, and write company comments for articles relevant for Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and ICSRs.

 

For Marketing Authorization Holders (MAHs) with active substances included in the European Medicines Agency (EMA)’s Medical Literature Monitoring (MLM) list, we perform weekly EudraVigilance checks using the ICSR Export module.

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Also, Gemini Group offers services of Local literature screening that includes:

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• Selecting relevant local (non-indexed) journals per country where the product is authorized (or propose local database if applicable)

• Regular monitoring of selected sources and documenting the process

• Maintaining records of regular local literature screening

• Insights on regulatory requirements for screening of local literature (LLS)

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Your service may be extended to full or part service, including:

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• Entry of identified cases into a validated safety database

• Full medical review of ICSRs

• Regulatory reporting of ICSRs

• Signal Detection and Benefit-Risk analysis

• Medical Assessment of safety issues

• Medical writing

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Why Choose Gemini Group For Pharmacovigilance Literature Screening Service?

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The requirement to proactively screen the published medical and scientific literature as part of a pharmacovigilance system can be challenging, time-consuming, and resource-intensive.

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The benefits of contracting Gemini Group to perform Global and Local Literature Screening are our subject matter expertise and industry leading knowledge. Gemini Group has a dedicated team with years of experience in literature monitoring adverse drug reactions for patient safety.

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Our dedicated team will meticulously manage literature-screening requirements together with the support of PV Physicians – medical reviewers (specialized in literature screening). We will help to identify important signals and provide benefit-risk comments on each literature reference.