Fact SheetAutomating PV Literature Surveillance for Adverse Events
Be Audit Ready and Compliant
Pharmacovigilance (PV) teams are bound by tight regulatory timeframes to identify, process, and report on adverse events and drug safety issues – expected to increase in volume by approximately 15% per year. With the growing volume of newly published articles, manual tracking of literature for adverse events can lead to mistakes, including accidentally omitted research, resulting in non-compliance, time-to-market delays, or removal of products from the market.
Enter DistillerSR for pharmacovigilance literature surveillance. The cloud-based platform brings together AI and intelligent workflows to automate and simplify the management and systematic assessment of literature to produce transparent, reproducible, and audit-ready reporting faster and more cost effectively.
Today, three of the top five pharmaceutical companies already trust DistillerSR to automate literature triage and ICSR identification processes. The result? Faster and more cost-efficient PV literature surveillance that is efficient, easy to manage, and compliant.
Import DistillerSR Reports to Third-party Safety Databases
DistillerSR’s public API allows the platform to be securely integrated with a broader technology ecosystem, including safety databases, signal detection and predictive analytics applications, reporting systems, data lakes, and others.
Faster and More Accurate Literature Triage with AI
DistillerSR’s advanced, integrated AI assists with literature screening, sorting and deduplication, reducing workloads, and accelerating the triage and assessment process. The software’s reranking AI runs seamlessly in the background, learning from reviewer screening behavior and continuously re-ordering references by likelihood of relevance or inclusion. As a result, your team sees the most relevant literature first.
Additionally, custom AI classifiers can be created and integrated with workflows. These classifiers automatically identify and tag references that meet specific criteria, allowing them to be routed immediately to subsequent stages of the workflow based on their characteristics. DistillerSR’s AI further enhances the quality of literature surveillance by identifying records that may have been
assessed by human reviewers and incorrectly excluded.
Connecting to a Literature Ecosystem
DistillerSR supports email alerts from platforms such as Ovid and EBSCO. Customers configure their search to automatically send newly found results directly to DistillerSR-based PV surveillance projects. This reduces or eliminates the need to run manual, time-consuming searches on a recurring basis. For organizations using in-house e-libraries to store full-text documents, DistillerSR provides OpenURL capabilities to allow reviewers direct access to these documents from within their DistillerSR workflows. The central management of full-text articles eliminates costly duplicate purchases and reduces copyright compliance issues.
With the above features and direct access to PubMed, PubMed Central, Article Galaxy, RightFind, and DOI.org, DistillerSR provides the widest range of reference sources in the industry.
Always Audit Ready
DistillerSR tracks all project activity with time and user stamps, to ensure total auditability and transparency. This includes all project changes, review data, reference imports, team workload, and performance.
All human-entered data is tracked and version controlled, ensures the clear provenance of every cell of data you export. Additionally, DistillerSR provides fully configurable user roles and permissions for the platform, as well as for every stage of the workflow. Providing team members with exactly the access they require simplifies the reviewer experience while also ensuring data integrity.
Simplified Management of Local and Global Teams
DistillerSR’s intelligent workflows automatically manages the assignment of inbound literature to team members, ensuring the right experts are paired with literature that is within their domain of expertise. Projects can easily be partitioned by user roles and responsibilities for centralized and simplified project management. DistillerSR notifies reviewers and teams when they have new work to complete and, using their cross-project dashboards, reviewers can easily see and access all the work they have left to do.
DistillerSR supports an unlimited number of concurrent users, which means that local and remote teams can collaborate easily, in real-time, while the system assigns tasks and ensures that no work is duplicated. User and project metrics help managers easily monitor their teams and the status of the literature surveillance process in real time, greatly improving oversight into projects and visibility into underutilized talent.
DistillerSR ensures PV literature surveillance is efficient, compliant, and audit ready.
For pharmacovigilance teams, monitoring existing and new literature for adverse events across often diverse drug portfolios is a highly manual and time-consuming effort. DistillerSR automates and streamlines PV literature surveillance for transparent, audit-ready, and compliant reporting.
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