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Bioclinica Announces Post-Approval Research Service

Deep experience and operational excellence offer an alternate way to conduct post-marketing studies.

January 27, 2016

Bioclinica®, a specialty clinical trials services and technology provider, announced today its newest service line offering.  The Post-Approval Research division of its Global Clinical Research business segment was created to meet the rapidly growing and ever-evolving needs of the post-approval research industry.

Bioclinica's expertise in designing and executing post-approval research for large, simple trials; complex post-approval safety studies; and patient-centric post-marketing studies provides a comprehensive, full-service, turnkey and cost-effective solution for pharmaceutical, biotech and medical device companies.

Leveraging its technology expertise, Bioclinica has built a post-approval study-specific technology platform which streamlines the overall study resource requirements. In addition, it offers full access to real-time study metrics and transparency for all stakeholders. Like all Bioclinica technology, the Post-Approval Research platform is flexible, scalable and customizable.

Bioclinica's Post-Approval Research operates a Program Coordinating Center (PCC) with dedicated and experienced post-approval research staff. The PCC provides global operational infrastructure from centralized locations to support local languages and time differences.  In addition, a unique service offering of the Post-Approval Research division is the development of the Patient Outreach Center (POC). Bioclinica's POC has carefully designed processes and technology which increases patient compliance and data collection by 25-30%, compared to traditional methodologies and Patient-Reported Outcomes technologies.

"At Bioclinica, we understand the fundamental differences between the design and conduct of post-approval studies and those performed prior to approval. We believe the substantial and deep domain knowledge of our management team, coupled with our state-of the-art-technology, allows us to achieve our strategic goals in post-approval research," said Dr. John Hubbard, President and CEO, Bioclinica (http://www.bioclinica.com).

Nayan Nanavati, COO, Bioclinica Post-Approval Research, adds, "Our full-service capabilities are designed to meet all post-approval study needs, from protocol development to operations through regulatory submissions. In doing so, we take a consultative approach, acting as an extension of our clients. We partner with them to establish key objectives and uncover ways to maximize efficiencies and enhance value.

"We're able to do this thanks to a unique combination of extensive global trial experience and industry knowledge; strategic, operational and regulatory expertise in post-approval studies; and a robust and fully-integrated technology infrastructure specifically designed for post-approval research. With our unique approach, we can complete post-approval studies more efficiently, with fewer resources, and most importantly, more cost-effectively."

Nayan Nanavati will present on the topic, "Patient-Centric Post-Approval Research – It's Time to Rethink How Post Approval Studies Are Done" at SCOPE Summit for Clinical Operations Executives, Wednesday, February 24, 2016, in Miami, FL. For information or registration, click here.

On Wednesday, March 16, 2016, from 10:00-11:00 am, Nayan Nanavati will present this same topic during a live Webinar. For information or registration, click here.

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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