For life science companies of any size, the detection, assessment, and prevention of adverse effects of their products/devices is not only important for maintaining patient safety, consumer trust, and overall market share, but also essential to ensuring they are in compliance with the requirements of the FDA, EMA and other regulatory bodies. A key component of successfully meeting the requirements these companies and their pharmacovigilance (PV) teams face is literature monitoring. Here’s a look into how CCC’s RightFind can support literature monitoring and management for pharmacovigilance in life sciences companies.
Safety Monitoring
The systematic screening of scientific journals for documented or possible adverse events (AEs) is a regular task within the pharmacovigilance workflow. With the amount of scientific and medical literature vastly increasing every year, the scope of this task continues to expand. With the enterprise literature management tool RightFind, companies can:
- monitor, review, and automate the literature review process to rapidly identify safety issues and adverse events
- get quick access to essential content, in order to satisfy regulatory inquiries and requirements
- facilitate copyright compliance by providing a real-time view into what permissions are available
Efficiency
RightFind serves the information management needs of the larger organization, with workflows tailored to specific groups. By creating workflows in RightFind, pharmacovigilance teams can easily manage weekly literature review processes.
- Alerts can be set up in RightFind, or in another literature database such as Embase or PubMed linking back to RightFind, to complete the workflow of obtaining the full text, storing the PDF, and concluding the review process.
- Shared libraries can be created to store the weekly alerts so that the entire PV team has access to the citations/documents. Setting up notifications within the shared libraries then allows the team to keep abreast of any changes made within the library such as added documents, new comments, annotations or tags.
- When scanning literature for adverse events, RightFind Insight enables reviewers to enrich documents with semantic categories to quickly identify concepts and their synonyms. With a simple click, the reviewer can easily jump through an article to each mention of any AE term to efficiently assess the article for safety issues, ultimately saving PV teams valuable time and effort.
Regulatory Compliance
Organizations need to ensure that their review process is documented. With RightFind, custom fields can be created to capture the review process, specific to your organization’s needs. Examples of custom fields include case numbers, date of initial review, status of the review process, and assessment. During the review process, changes to these fields are captured in the audit trail, including notations when edits were made and by whom. The audit trail can be exported as part of a report on the shared library and used to show that the review process was done properly.
Copyright Compliance
In using RightFind, the risk of copyright infringement is minimized since the company’s annual copyright license and subscriptions are integrated and checked with each access of a PDF. The user chooses the type of use they require for a document when they order and then if permitted, the PDF is added to a central library for re-use within the organization based on the company’s subscriptions and licenses. RightFind takes any guesswork out of the equation and allows for your organization to effortlessly manage copyright, reducing the risk of infringement.
Scalability
While the PV group may require workflows and libraries specific to their process, RightFind is scalable and can be used across functional groups while maintaining and promoting copyright compliance. By enabling sharing of documents from a central location, content can be accessed via corporate subscriptions and in accordance with license rights. With an enterprise literature management system, an organization can avoid silos of content and create a more efficient way for the enterprise to access, share and manage literature.
In my experience as an information management consultant for many life sciences organizations, I have found that RightFind is a configurable literature management solution for pharmacovigilance teams and the entire life science organization that can enable workflows and collaboration to enhance productivity, reduce inefficiencies and silos, and facilitate compliance across the board.
If you have recently found yourself looking for a new literature management tool, learn more about CCC’s RightFind Suite and see how else it can support your Pharmacovigilance, Medical Affairs or other teams from my prior blog posts:
Why Scientific Literature and Copyright Compliance Are Essential to Medical Affairs
8 Key Features to Consider When Replacing QUOSA as Your Literature Management Tool