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Clinical Research

CRO (Contract Research Organization) Services

Place your product in the right hands with Life Extension's turnkey Clinical Research team.

Who We Are

Life Extension Clinical Research, Inc. (LECR) is a nationally recognized research organization committed to providing nutraceutical and pharmaceutical development services to nutraceutical, pharmaceutical, biotechnology, and medical device companies. We can provide a thorough scope of service offerings to meet your needs. We can assist you with the many aspects of the nutraceutical or drug development process including the design, conduct and management of the clinical studies, protocol and informed consent development, management of the data processing activities, case report form design, Institutional Review Committee oversight, generation of statistical analyses, formulation of statistical and clinical study reports, as well as management and performance of compliance activities.

Life Extension Clinical Research, Inc. designs, manages, and conducts clinical studies with quality of service and safety for our subjects as the primary focus. We believe that the key to success is the desire to meet and exceed client expectations. We understand the clinical development process to bring your product to market and recognize the critical nature of accurate and timely data collection in a cost effective manner. The quality of communication and successful relationships developed with our clients is a vital and integral core focus. Our operational flexibility allows us to respond quickly to client and regulatory requirements and modifications as well as create strategies to accomplish the specific needs at hand with all services provided by Life Extension Clinical Research, Inc.

The staff at Life Extension Clinical Research, Inc. are well-versed in clinical research methodology, applicable regulations and guidelines and include physicians, scientists, pharmacists, statisticians, data managers, and clinical research assistants and coordinators. There is also an in-house laboratory with experienced phlebotomists.

Our subject database further strengthens our ability to rapidly recruit and enroll appropriate study subjects.

What We Do

LECR has worked in a variety of clinical implications, including:

  • Cardiovascular health
  • Dyslipidemia
  • Obesity and weight management
  • Metabolic syndrome
  • Hormone therapy and endocrinologic disorders
  • Glycemic and blood glucose control
  • Cognitive studies for stress and depression
  • Male sexual health
  • Women’s health
  • Bone health
  • Skin care and dermatology
  • Pharmacokinetics studies
  • Product tolerability studies
  • Product bioavailability studies

Selected Clinical Studies recently conducted at Life Extension Clinical Research, Inc. include:

  • Cardiovascular endothelial function
  • Cholesterol-lowering
  • Weight loss
  • Natural sexual health
  • Sleep/mood/appetite
  • Male sexual health
  • Hair growth inhibitor
  • Coenzyme Q10 bioavailability

Our Major Service Areas Include:

  • Clinical Development, including study design, protocol writing, and SOP writing
  • Regulatory Affairs (Consulting and submission services, pharmacovigilance/safety), and regulatory submission
  • Biometrics (Clinical data management, sample size calculation, randomization, and biostatistic analysis)
  • A panel of sophisticated laboratory analyses
  • Production concept development, and optimized formulations
  • Preparation of documentation, clinical study reports, and manuscript writing

Study Subjects Demographics and Access

Our location provides access to South Florida’s broad scope of subjects, encompassing a multitude of ethnicities, races, and disease states. Our recruitment team develops outreach methods and materials to increase exposure that is created through direct-to-consumer outreach methods such as radio, print, and local/community newspaper advertising, direct mail and Internet listings.

Contact Us

If you are interested in placing a study at Life Extension Clinical Research, Inc. or if you have any questions, please contact us at:

Dr. Steven Hirsh
Director of Clinical Research
Life Extension Clinical Research, Inc.
5990 North Federal Highway,
Fort Lauderdale, FL 33308
Phone: (954) 202-7679
Fax: (954) 202-7681
E-mail: shirsh@lifeextension.com

For more information on current open studies visit www.lef.org/ClinicalResearch