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PRINCETON, NJ, June 25, 2018 – Bioclinica®, a global life sciences services provider that utilizes science and technology to bring clarity to clinical trials, today introduces its expanded and enhanced SMART technology suite available with Medical Imaging, Electronic Data Capture (EDC) and Interactive Response Technology (IRT) combined, driving highest quality data and compliance in clinical trials. Bioclinica’s proven, synchronous clinical trial technologies converge all essential activities in a common data set. Investigative sites can access Medical Imaging, EDC and IRT data via a single, easy-to-use portal where they can view, analyze and act on the data. Implementation is underway by a top 15 pharmaceutical company and a top five CRO who are using Bioclinica’s enhanced SMART technology for their global trial portfolio.
“Our clients are already using our best-in-class SMART technology suite to submit, manage, analyze, report and transfer medical image data compliant with global data privacy and regulatory requirements. With these new enhancements, we’re providing sponsors and CROs a catalyst to effectively and efficiently consume data throughout the trial,” says Bioclinica President & CEO David Herron. “By allowing sites to see critical activities together, SMART eliminates rework, creating tangible value in efficiency, quality and compliance along the data chain of custody.”
“Data transparency with real-time data reconciliation capability from start to finish is a real game-changer for our clients and their trials,” says Bioclinica’s Chief Information Officer Gavin Nichols. “SMART erases boundaries that separate processes and information.” A major benefit of real-time data reconciliation is the elimination of a significant amount of site re-work, duplicate data entry and queries between systems – all of which slow database lock. Additionally, automation replaces inefficient manual methods of query resolution, such as email, mail and phone calls.
Advantages extend to sponsors and CROs in the way of overall reduced data management effort and faster database lock. Sites, for instance, are able to skip these data cleaning steps since information is automatically and continuously updated and scrubbed, preventing downstream errors that can potentially impact data quality and compliance.
Using SMART with Bioclinica’s rapid-start IRT, gives clients a prototype patient screening, enrollment and dispensing system within days of protocol receipt. The technology suite allows plug-in functionality with Bioclinica Site & Patient Payments, Cardiac Safety (ECG and ABPM), and Clinical Event Adjudication, as well as third-party providers.
SMART was developed through collaboration among Bioclinica technology developers and inhouse medical experts with input from industry-leading life sciences companies. “The result is clinical trial technology with the flexibility to adapt to clients' needs regardless of the size or complexity of the study protocol,” Herron explains. “Our end goal is enabling sponsors and CRO partners with better management and execution of more highly complex clinical trials on a global scale.”
Earlier this year, Clinical Informatics News recognized Bioclinica SMART with a Best Practices Award for innovation in patient data management.
Bioclinica will preview SMART at the DIA Annual Global Meeting in Boston on June 24-28 where the company is exhibiting and presenting. Anyone interested is invited to schedule a one-on-one meeting during DIA or another time.
Bioclinica is a global life science 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 and cardiac safety services; clinical adjudication; randomization & trial supply management and optimization; electronic and eSource data capture; site & patient payments and budget forecasting; pharmacovigilance; trial management; and risk-based monitoring solutions. A true multifaceted partner to trial sponsors and Contract Research Organizations (CROs), Bioclinica offers a global network of research sites and patient recruitment services 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 the top 20 biopharmaceutical companies and leading CROs – through a network of offices in the U.S., Europe, and Asia.