COResearch

Talking with Scott Neff, Global Head of Business Development for COResearch, a business unit of Duke Medical Strategies, Inc.

NGP. Tell me about COResearch
SN. COResearch is a business unit of Duke Medical Strategies, Inc. and is one of the largest, most experienced ECG and Echo core laboratories in the world. COResearch has 23 years of experience in providing electrocardiographic (ECG) central laboratory services for multicenter clinical trials in support of regulatory submission for new drugs, biologics, and medical devices and more than 40 years of experience as an echocardiography laboratory.

We have specific expertise in ST monitoring with over 50 trials and over 500 sites that have been coordinated through our group. In addition, our core lab is integrated with the Duke Central Diagnostic Services group where we coordinate and perform over 2600 exercise treadmill tests per year. Our Echo core laboratory experience started with M mode in the 1960s, development of 2D and 3D echocardiography in the 70’s and 80’s (respectively), and early adoption of Doppler technology providing a depth of experience that is unparalleled in other Echo core laboratories.

NGP. How did COResearch Begin?
SN. In 2004, the ECG Core Lab at the Duke Clinical Research Institute evolved to meet the growing needs of the pharmaceutical industry in response to recent changes in regulatory requirements. COResearch provides centralized, Part 11 compliant ECG and Echo core laboratory services that are seamlessly interlaced with a full suite of global clinical research services. With our academic roots, full-service capabilities, cutting-edge technology, accuracy, reproducibility, and regulatory experience, no other commercial or academic core lab is able to offer the same breadth of strategic and operational services in a single package.

NGP. Explain the relationship to Duke and is contracting with COResearch simple?
SN. The ECG core laboratory has been in operation at Duke continuously over the past 23 years serving both large trials (such as Gusto V and Pursuit) as well as small trials. Together, COResearch / DCRI provide the most experienced core laboratory. Our combined experience is as follows:

• Over 23 years as a core lab / technology company
• 127,605 patient hours of digital ECGs
• 14,151,504 digital ECGs collected / archived
• > 120 international trials in 47 countries
• Equipment provision to more than 7000 sites

COResearch was developed as a separate business unit out of the DCRI’s core laboratory group to be able to provide fee-for-service work for trials by which the academic components of the DCRI are not needed, thus contracting is simple and like doing business with any other commercial Core Lab.

NGP. What is your business philosophy?
SN. Our goal is to assist sponsors in drug development and approval to improve the care of patients through cost-effective science in the development of new molecular entities (NMEs). COResearch has a specific focus on protocol design, state-of-the-art monitoring, data interpretation and defense. Based on our regulatory experience, we believe that effective core laboratory services begin with an appropriate protocol that is tailored to the specific aim of the scientific question in respect to the properties of new molecular entities Specifically, we believe that there is no single correct approach to trial design but rather each trial must be designed based upon the specific properties of the NME and the specific aims of the study.

NGP. What types of Core Lab services do you offer?
SN. COResearch provides high fidelity, digital core laboratory measures of cardiac safety and efficacy for NME’s and devices in Phase I through Phase IV. Our capabilities incorporate a full-range of cardiac safety and efficacy core laboratory services, including resting and continuous ECG, echocardiography, ischemia and ETT monitoring, trial design, data interpretation and analysis, global study management, and regulatory strategy consultation.

NGP. Are the ECG and ECHO readings outsourced?
SN. Absolutely not. All interpretation is conducted by board-certified cardiologists who are faculty members of the Department of Medicine / Division of Cardiology of the Duke University School of Medicine. All physician ECG/ECHO readers have undergone specific training on the systems employed to read ECGs/ ECHOs for core lab purposes and the pertinent SOPs and QA processes. All study cardiologists will participate in the QA processes by over-reading random samples of separate cardiologist’s interpretations for reliability testing as dictated by COResearch SOPs.

NGP. Can ECG waveforms be viewed over an internet connection via a web browser?
SN. Yes, this access available to the Sponsor and sites too. In addition to 24/7 access to patient records, COResearch provides dynamic access to selected study information through web reporting. Our standard offering includes graphs, charts and tables that assist sites in tracking patient enrollment (and other key indicators) in comparison to the average performance across all sites. COResearch’s online access provides the ability to measure the study’s overall performance along with each individual site’s metrics. Depending on the final specifications, multiple graphs and charts can be created to represent current data in detailed report formats to help measure study performance. As additional data management needs occur, we have developers available to generate complex SQL queries that represent one-to-many and many-to-many frequency tables. The results of these reports can be provided online in an HTML format or delivered in Excel file format.