LitTrace, PVTrace and SigTrace provide an interconnected pharmacovigilance continuum
Bioclinica®, a specialty clinical trials technology and services provider, today announced the expansion of its extensive Safety & Regulatory Solutions portfolio by introducing three new software products to manage every stage in the pharmacovigilance process. The solutions make it possible for pharma and biotech companies to see both the big picture and the details to satisfy safety and regulatory requirements. The new applications include:
- LitTrace™: A singular application that brings visibility to the literature surveillance and monitoring continuum;
- PVTrace™: A quality, productivity and compliance tracking product that brings transparency to the entire pharmacovigilance process; and
- SigTrace™: A one-source solution to complex signaling, including signal management and archiving.
"Each product is a one-source application that contributes to a fully integrated solution where an organization can turn for information to manage all key aspects of the pharmacovigilance process," said Senior Vice President and Managing Director of the eHealth - Safety & Regulatory Solutions division, Sankesh Abbhi.
The first of the applications, LitTrace, combines all literature surveillance activities into one validated application for quick and easy access to consolidated safety related literature within a central repository. The solution has the capability to generate E2B XML files of the case/literature hit, which can be uploaded to the safety database. Reports on identified issues and compliance can be generated for any time period, helping teams keep apprised of ICSRs and aggregate reporting hits. Vice president of Global Client Relations, Ramprasad Govindarajan, MD, who led the team in creation of the application, explained, "Most in the industry must rely on various databases and tools to monitor and share information. As an alternative, we created a one-of-a-kind technology-enabled solution for an easier and more efficient way to stay on top of compliance without fear of missing relevant articles." LitTrace is adaptable to any literature search engine, including Embase, MEDLINE and PubMed, and allows customized report generation to suit MAH requirements.
The second application, PVTrace, shares the same core functionality as the system Bioclinica uses on pharmacovigilance projects conducted for its own clients. "Day-to-day activities of PV and tracking can be especially challenging.
PVTrace is a simple and smart solution, making everything from graphs and other outputs far easier than manual methods," Dr. Govindarajan remarked. Among the key features found in PVTrace are team-wide tracking of outputs, performance per day, and priority listing. "No other application combines the ability to track quality and reporting timelines in a single solution. Whether an organization handles pharmacovigilance internally or externally, it provides insight as to how resources are performing across the entire process." This automatic feedback loop facilitates continuous improvement and aids in identifying areas of targeted retraining.
The third new application, SigTrace, is focused on signal management processes and procedures. "Signal detection requires high-end monitoring," Dr. Govindarajan explained. "Be it quantitative or qualitative, SigTrace, shifts the focus to medical analysis where there is tremendous value." The application is pre-coded to detect the frequency of new signals at fixed intervals. "SigTrace supports complete signal management with in-application gathering, identification, analysis and management of these signals." All signal related documents, validated information from the safety database, and decision trees used in report generation are captured in a unified database.
These three new applications, together with Bioclinica's industry-leading Safety & Regulatory Solutions offerings, form a complete enterprise safety and regulatory information platform with global consulting services available from Bioclinica's eHealth Solutions team. "With these new products, pharmacovigilance information is reliable and always accessible," Abbhi said. "Whether literature surveillance, compliance or signal detection and management, our platform of eHealth and Safety & Regulatory Solutions is helping to evolve the industry by leveraging technology for enhanced quality and safety." To kick-off the trio of new products Bioclinica will be conducting demonstrations in its exhibit at the DIA Annual Meeting on June 26-30.