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LitTRACE: Simplified Tracking and Assessment of Safety-Related Literature

The scientific literature has always been a very dependable source of information for identifying drug safety-related information, such as Individual Case Safety Reports (ICSRs), signals, aggregate report relevant information and epidemiology data. Tracking this safety information is mandated by regulatory agencies. Relevant safety information published in national and international journals, including that from local journals, conferences and symposia, are considered for assessment. The manual process of sifting through individual articles and journals, tracking the information and record keeping requires considerable time and resources.

At Bioclinica, we strive to streamline the time-consuming, resource-intensive, but critical, tasks for your literature review activities, freeing up resources to concentrate on medical analyses and relevance assessments. With LitTRACE, we aimed to create a user-friendly, fully-customizable and semi-automated literature assessment and tracking tool to help monitor safety and to meet the associated regulatory requirements. And, we think that we succeeded.

This enables timely access to reliable and consolidated information pertaining to adverse event reporting and product benefit risk evaluation from the literature that you can use for clinical evaluations, pre-market approvals and adverse events reporting. The LitTRACE tool also creates databases for ICSRs and similar compliance reports.

What sets LitTRACE apart? It serves as a central repository for weekly hits and full-text articles, as well as associated workflows.

Set-up and Configuration

Workflow Tools

Outputs

Fully configurable for each client’s unique requirements

Role assignment for literature review or assessment

Standard and configurable reporting

Flexible folder structure in which you can build multiple folders based on product or therapeutic areas

Full audit trail, including date and time of report requests

Data can be pulled for any timeframe

Direct data import from third-party sources such as EMBASE, PubMed, Ovid or EMA medical literature monitoring (MLM).

User reports

Facilitates signal detection

Hosted in your company environment or at BioClinica

E2B XML generation for integration with ArisG/Argus.

Facilitates aggregate reports or risk minimization plan

 

Therefore, LitTRACE is a one-stop solution for performing regular literature assessment for all company medicinal products; requesting, collating and archiving full-text articles; performing translation; and generating automated reports of records (weekly, monthly, annual and customized) at any given time point. This helps with documentation and audit preparedness in compliance with health authority (FDA, EMEA and other global regulatory bodies) requirements.

While its main purpose is currently for literature reviews, we also see the potential for LitTRACE to play a role in signal detection, aggregate reporting and risk minimization plans.

If you have any questions about LitTRACE, I'd be happy to talk with you. Feel free to reach out to me in an email at nirathi.prasanna@bioclinica.com.

LitTrace and PVTrace Overview Sheet

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Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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