Our staff has over 35 years of research experience in all types of clinical trials.

Our mission is to aid and support your research with quality, integrity and leadership; creating talented teams that focus on results.

Comprehensive Research Associates, Inc, is currently focused on developing and implementing strategies to enable companies to not only survive but to thrive. We focus on all aspects of drug development in the Biotechnology, Academic, Device, Investigator initiated studies, and Pharmaceutical areas.

Mission Statement:
To offer comprehensive and efficient quality research services for all phases of clinical research that focus on results.

No project is too big or too small.

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W. Frank Peacock, MD, FACEP

W. Frank Peacock IV, MD, FACEP is the immediate past Chief Medical Officer, and prior President of the Society of Cardiovascular Patient Care (formerly known as the Society for Chest Pain Centers). Previously, Dr. Peacock served as Professor, Cleveland Clinic Lerner College of Medicine and Case Western Reserve University, Cleveland, Ohio, and was Vice Chair of Emergency Medicine Research at the Cleveland Clinic where he also served as Director of Event Medicine (responsible for the medical care of the Cleveland Browns, Cleveland Cavaliers, and Cleveland Indians' Stadiums). He recently moved to become Professor of Emergency Medicine, Associate Chair, and Research Director for Emergency Medicine at the Baylor College of Medicine, in Houston, Texas. He is a frequently invited speaker for numerous domestic and international cardiology and emergency medicine meetings.

With over 300 publications on heart failure and acute coronary syndromes, Dr. Peacock is also the co-editor of the textbooks "Cardiac Emergencies", "Short Stay Management of Heart Failure", and "Short Stay Management of Chest Pain". He is the 2004 and 2010 winner of the Best Research Paper Award from the American College of Emergency Physicians, and is the Codman Award recipient from the American Association of Group Practice.

Dr. Peacock has been and continues to serve as PI or co-PI for many high profile national and international clinical trials such as PRONTO, ADHERE-EM, IMPACT, CHOPIN, CLUE, FASTTRACK, and TRUE-HF. Dr. Peacock’s clinical interests and research focus include acute coronary syndrome, acute heart failure, biomarkers, improvements in emergency medical care and more rapid patient disposition. Dr. Peacock received his medical degree from Wayne State University Medical School and completed his Emergency Medicine training at William Beaumont Hospital, Detroit, Michigan.

Beth Gaul, RN

Beth Gaul, RN has had 10 years’ experience in the research world, first as a RN Research Coordinator at the Cleveland Clinic Institute of Emergency Medicine and more recently as Chief Executive of Comprehensive Research Associates, INC. She participated in all aspects of many trials from large corporate sponsored trials to NIH grants and Investigator initiated trials.

Thirty plus years in Medicine and her more recent research experience make her well suited to assist in designing and managing your clinical projects from start to finish. She has firsthand experience and understands the issues in developing and running your trial.

PRE-TRIAL CONSULTING

With more than 20 years experience each in the design and performance of hundreds of clinical trials, Dr. Frank Peacock has an unequalled track record of success. With his years of experience, he is able to structure trials that meet their clinical endpoints in the most efficient and economically responsible fashion. While Dr. Peacock is available in a consultative capacity, Comprehensive Research Associates also enjoys unparalleled relationships with high profile individuals that may be able to participate when unique specialty or professional requirements are needed. If you are interested in an evaluation of a future or current trial strategy, an approach for reaching FDA clearance, or want to determine the probability of success of a grant submission, please contact us via one of the methods in our Contact Us page below.

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PLANNING

o   - Clinical Research Design, Development and Validation

• - Protocol Development for FDA Registries and trials

o   - Apply and obtain FDA IND (Investigational New Drug) documents and IDE (Investigational Device Exemption)

• - Design and or manage an electronic data base (Create a Case Report Form -eCRF)

o   - Site Selection (Assessment of sites to determine if they are able to execute and enroll in your study)

• - Investigator Qualification and Selection (Determine if the Investigator has the experience to be a successful PI)

INITIATING

o   - Clinical Trials Budget Development and Negotiation

• - Plan and execute a site Investigator Meeting

o   - Site Initiation Visits for Participating sites

• - Regulatory Compliance following GCP Guidelines

MAINTENANCE

o   - Clinical Monitoring including site visits

• - Audit Preparation for a sponsor or the FDA

o   - Data management and statistical analysis

• - Close out preparation and management

OTHER SERVICES

o   - Manuscript preparation and submission for publication

• - Any teaching needs

o   - Temporary staffing needs

• - Informed Consent Language Translation to Spanish

Development to Marketing:

19.  B-type natriuretic peptide, from pre-market FDA approval to over 1 billion dollars per year in sales

20.  Clevidipine, from pre-market approval to successful FDA approval and launch

21.  Nesiritide, from pre-market approval to nearly 750 million dollars in annual sales at its peak

22.  Ischemia modified albumin, from development to FDA clearance and sale of company

Early Phase I and II investigations:

23.  Nasopharyngeal therapeutic hypothermia technology

24.  Unbound free fatty acid marker investigation for suspected acute coronary syndrome

25.  Early automatic external defibrillator evaluations

26.  Neural stimulation for relief of bronchoconstriction

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