Overview

Background

Literature monitoring is the process of searching published literature for data about products. Sources of literature may be published newspapers, internet websites, medical journals, periodicals, radio broadcasts, or television broadcasts. The information generated from these sources can be commonly referred to as medical literature regardless of the source. Literature must be collected because it presents the "state of the science" or accumulated knowledge on a specific topic. The information collected can also be used to inform professionals and patients of the best available evidence when making healthcare decisions, influence policy, and identify future research priorities for a particular company. The key challenge inherent in the storage and management of literature is maintaining the integrity of the information while ensuring proper document accessibility and regulatory compliance. This involves several critical aspects:

  1. Collection of Data: Information regarding products should be stored separately, preferably in a dedicated repository distinct from other company documents, to enhance the efficiency of information gathering and retrieval. This requires a robust system for categorizing and segregating documents.
  2. Access Control: Strict access controls must be implemented to ensure that only authorized personnel can view potentially sensitive information and categorize collected literature. This includes setting permissions and audit trails to monitor who accesses what information and when.
  3. Regulatory Compliance: Ensuring compliance with regulatory requirements when working with products such as Good Clinical Practice (GCP), GDPR, and other relevant guidelines is essential. This includes maintaining secure, traceable, and auditable records.
  4. Document Integrity: Maintaining the integrity and confidentiality of product information while enabling necessary updates and collaboration can be challenging. This requires distinct control of user access and user permissions. This may also encompass certified translations of literature to or from multiple languages to ensure the integrity of the document content.

What is a Literature Monitoring Solution?

Trial Interactive’s Literature Monitoring solution provides a validated, dedicated repository to electronically store pieces of information for products from an unlimited amount of sources. It also enables a literature review team to follow essential processes for metadata collection and document access.

What does the Solution do?

  • Leverages configuration to support storage of over 250 file types.
  • Provides quick and easy ability to categorize literature.
  • Contains a streamlined filing structure developed from industry experts.
  • Facilitate the ability of a user to identify sensitive document content prior to filing.

System/Technical Requirements

  • The Literature Monitoring solution is assumed to have an unlimited number of users with approved access to documents.
  • This solution has a streamlined index targeting literature review file types.
  • This solution has TransPort Translations enabled to easily request a certified translation of any documentation.
  • This solution has the ability to perform Quality Review for oversight.

High level technical capabilities:

  • Users can view, modify metadata on documents within a workflow
  • Users can Copy/move documents between rooms
  • Users can perform translation requests for certified translations
  • Users can run reports on Inventory, KPIs, User Access
  • Ability to access Audit Trail
  • Ability to add or remove user access

Solutions available for interoperability:

  • GlobalLearn
  • TI Connector