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Grunenthal Expands Use of BioClinica's Next Generation Trident IWR/IVR for Global Trial
Date:6/20/2013

NEWTOWN, Pa., June 20, 2013 /PRNewswire/ -- BioClinica®, Inc., a global provider of clinical trial management solutions, announced today that Grunenthal GmbH will again utilize the latest enhancements in Trident IWR/IVR for a global clinical study on pain medication. The three-year study will involve 350 patients at 80 sites across 17 countries. Trident streamlines the clinical trials process, making it faster and easier to set up, test, and deploy clinical study protocols.

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The integration of Trident into Grunenthal's clinical trial process is already underway. The new interactive web and voice response technology replaces a manual system for managing inventory, returns, and accountability of controlled substances. Trident automates these tasks and makes it easier to stay in compliance with controlled substance regulations, an especially important consideration for a pain management specialist.

In evaluating IVRs, no other technology provider met the controlled substance functionality Grunenthal needed. BioClinica responded by developing a customized solution. "BioClinica listened to our needs and built the functionality we needed into their IRT system in time for our deadline," said Henk Dieteren, Associate Director, Head Clinical Supply Manager, Compound Development and Branding, Clinical Development Operations, Clinical Trial Supply.  "We envision IRT systems becoming an integral part of our controlled substance studies," Dieteren added."Trident's ability to manage controlled substance inventory is crucial to meet strict regulatory requirements for conducting clinical trials that involve investigative compounds related to pain management."

The selection of Trident expands Grunenthal's use of BioClinica solutions, specifically OnPoint CTMS. In March 2012, the pharmaceutical company penned an agreement to use the customizable clinical trial management system enterprise-wide for gathering and sharing clinical trials information. Grunenthal made the selection recognizing OnPoint CTMS could help further innovation and development of new pain therapies.

"We are very pleased Grunenthal is expanding its use of BioClinica products to include Trident," said Peter Benton, BioClinica's President of eClinical Solutions. "The BioClinica suite of eClinical solutions is designed especially for this kind of integration, and will help Grunenthal manage its future clinical trials more efficiently."    

Trident reduces the average time it takes to write, set up, and validate IWR and IVR protocols from months to weeks. Trident supports all of a sponsor's clinical studies within a standardized data model that better supports automatic drug pooling and reporting.  By giving clinical trial sponsors the ability to monitor and maintain all their study protocols in one place, it is more efficient and cost-effective than developing specifications, programming and validating a new IWR system for each new study.

BioClinica is offering a free webinar on the subject of controlled substance studies titled Controlled Substance Studies: Meeting the Supply Management Challenge on August 8th, 2013 at 11:00 AM Eastern Time. BioClinica representatives will also be available to demonstrate the company's leading eClinical solutions at the Drug Information Association annual meeting June 24th through 26th in Boston, Massachusetts in Booth #1210.

Follow BioClinica on the Trial Blazers blog at http://info.bioclinica.com/blog, and on Twitter at http://twitter.com/bioclinica.

About the Grunenthal GmbH

Grunenthal GmbH is an independent, family-owned international research-based pharmaceutical company headquartered in Aachen, Germany. Building on its unique position in pain treatment, its objective is to become the most patient-centric company and thus be a leader in therapy innovation. Altogether, Grunenthal GmbH has affiliates in 26 countries worldwide. Grunenthal products are sold in more than 155 countries and approximately 4,200 employees are working for Grunenthal GmbH globally. In 2011, Grunenthal achieved revenues of about 947M €. For more information: www.grunenthal.com.

About BioClinica, Inc.

BioClinica, Inc. is a leading global provider of integrated, technology-enhanced clinical trial management services. A 2013 merger with CoreLab Partners has created a new standard in imaging core lab services including electronic transfer, management, and independent review; cardiovascular safety monitoring including automated ECG, Thorough QT studies, Holter monitoring, ambulatory blood pressure monitoring and pulse wave analysis; and eClinical solutions for electronic data capture, randomization, clinical trial management, and clinical supply chain forecasting and optimization. BioClinica offers unmatched scientific expertise with a team of respected medical researchers and board certified, sub-specialty trained radiologists, cardiologists, nuclear medicine physicians and oncologists. With more than 28 years of experience and over 3,000 successful trials to date, BioClinica has supported the development of many new medicines through all phases of the clinical trial process. BioClinica operates state-of-the-art, regulatory-body-compliant imaging core labs on two continents, and supports worldwide comprehensive cardiovascular safety, and eClinical and data management services from offices in the United States, Europe and Asia. For more information, please visit www.bioclinica.com.


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