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Bioclinica eHealth Solutions Launches Safety and Regulatory Software Products

LitTrace, PVTrace and SigTrace provide an interconnected pharmacovigilance continuum

June 22, 2016

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.

About Bioclinica
Bioclinica is a global life sciences solution provider that utilizes science and technology to bring clarity to clinical trials – helping companies to develop new life-improving therapies more efficiently and safely. Successful clinical trials require the ability to see key details and uncover hidden insights, and Bioclinica’s hundreds of experienced scientific, medical, and domain experts bring unmatched insight across the development lifecycle, from the initial protocol to post-approval.  The company’s cloud-based offerings include medical imaging, cardiac safety, randomization and trial supply management and optimization, electronic and eSource data capture, site payments and forecasting, pharmacovigilance, trial management, and risk-based monitoring solutions. A true multifaceted partner to trial sponsors and Contract Research Organizations (CROs), Bioclinica offers an integrated App xChange partner ecosystem, a global network of research sites, patient recruitment services, and post-approval research expertise to provide committed, detail-focused service through all stages of drug development.  The company’s thousands of employees serve more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 biopharmaceutical companies and leading CROs – through a network of offices in the U.S., Europe, and Asia. Learn more about Bioclinica at www.Bioclinica.com and on Bioclinica LinkedIn and Twitter.

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle 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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