Prelude EDC Clinical Trial Optimization Platform (CTOP) Instrumental in Conducting Head Injury Research in a Multi-Hospital Study

Prelude EDC Clinical Trial Optimization Platform (CTOP) instrumental in conducting head injury research in a multi-hospital study.

This study enabled BrainScope® Company Inc. to receive FDA clearance for the AHEAD® 300. The study’s principal investigator was Daniel Hanley Jr., M.D., the Legum Professor of Neurological Medicine and director of the Brain Injury Outcomes Program at Johns Hopkins University School of Medicine.

The AHEAD technology is a hand-held EEG device that is now commercially available for use at point of care to determine if a person with a head injury is likely to have a brain bleed requiring further evaluation and treatment. This new technology will assist in finding patients the right care pathway, ultimately reducing the time and cost of care.

Prelude Dynamics provided BrainScope with a fully customized solution that allowed patient histories, head injury related information, symptoms and assessments to be directly entered in Prelude EDC. Based on certain criteria, Prelude EDC also ran a series of complex calculations to determine traumatic brain injury scoring. BrainScope took advantage of Prelude EDC’s document management tool to store critical study documents that needed to be shared across study personnel and researchers.

Doug Oberly, Vice President, Customer Care at BrainScope, commented, “We have used other EDC systems in the past and BrainScope Clinical Affairs staff and our clinical site partners have been very pleased with the Prelude EDC system. We found Prelude EDC to be more than capable to suit all our study needs and have chosen to use Prelude EDC for three other clinical studies.”

Emissary used Prelude EDC’s integrated monitoring tools to ensure the validity of data. These tools included a dashboard, automatic and custom queries attached to each field, query summaries and charts, and ad- hoc reports.

Steven Mayo, Pharm.D., CEO of Emissary International, commented, “Prelude Dynamic’s Prelude EDC was instrumental in allowing us to remotely monitor the study. We collected CT and AHEAD-300 data files directly in Prelude EDC, which greatly simplified our ability to process this data and close the database quickly after the last enrollment. I can’t imagine doing this study without Prelude EDC.”

Emissary International served as the contract research organization (CRO) providing data management, monitoring, training and project management in conjunction with the Brain Injury Outcomes coordinating center at Johns Hopkins University. Emissary is an award-winning CRO that has been accelerating clinical trials since 1995 and has worked collaboratively with Johns Hopkins University since 2006.

Alicia Browner, Ph.D., CTO of Prelude Dynamics said, “We are excited that BrainScope’s AHEAD technology will help people with head injuries get the treatment they need faster by identifying potential bleeds sooner. We are glad to be a part of enabling critical clinical research with our Clinical Trial Optimization Platform, bringing such devices and pharmaceuticals to market quicker.”

About Emissary

Emissary International LLC is a contract clinical research organization (CRO) providing services to biopharmaceutical, medical device and academic organizations engaged in the conduct of clinical trials. Since 1995, Emissary has been leading medically-intensive research studies across a broad range of therapeutic areas, helping clients bring dozens of new medical products to market quickly and efficiently.

Emissary is recognized as one of the more innovative CROs in the industry, having received awards for being one of the first companies to develop an international network of monitors and trialists, pioneering one of the first commercial electronic data capture (EDC) systems, developing the TeamTrials® clinical project management system, and more recently for its involvement in the NIH’s Trial Innovation Network along with a number of large academic medical institutions, a major 7-year effort to streamline the conduct of multicenter clinical trials.

About Prelude Dynamics

Prelude Dynamics is a global provider of innovative software for conducting both human and veterinary clinical trials. The Prelude EDC software system, the only Clinical Trial Optimization Platform (CTOP) available in the industry, takes EDC to the next level by supporting a continuum of study development options that fully integrate into your workflow through do-it-yourself and full-service custom study builds.

Prelude Dynamics has earned the reputation for helping accelerate and advance product approvals for our customers worldwide, including global pharmaceutical companies, biotechnology, diagnostic, and device companies, along with leading academic medical centers, such as The Johns Hopkins University Medical Center, and contract research organizations.

The company’s flagship product, Prelude EDC often referred to as the industry’s first “Clinical Trials Optimization Platform” (CTOP), offers a validated, secure, and configurable platform, compliant with FDA/CVM 21 CFR Part 11 Guidance and EMEA regulations.