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Medical Nutrition R&D Enterprise of America has a variety of clinical sites and investigators including academic centers, research clinics and hospitals. We also have an extensive pool of investigators with a variety of specialties including: allergy, dermatology, gastroenterology, gynecology, infectious disease, integrative medicine, internal medicine, oncology, pain management, urology and CAM specialties.

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Medical Nutrition R&D Enterprises of America has worked in a variety of clinical implications, including:

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• Cardiovascular health

• Dyslipidemia

• Brain Health

• Cognitive Improvement studies

• 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

• Cardiovascular endothelial function

• Cholesterol-lowering

• Weight loss

• Natural sexual health

• Sleep/mood/appetite

• Male sexual health

• Hair growth inhibitor

• Coenzyme Q10 bioavailability

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We provide various kinds of clinical research, medical writing and consulting services including:

 

Basic Science and Clinical Research Services

• Production concept development

• Optimized formulations

 

 

Clinical Trial Development

• Protocol development for basic science and preclinical research, pilot studies, and phase I-IV clinical trials

• Investigator brochures

• Case report forms, clinical site binders and study reports

• Institutional Review Board (IRB) submission and maintenance

• Statistical analysis and Biometrics (including clinical data management, sample size calculation, randomization, and biostatistics analysis).

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Clinical Site Selection and Management of Clinical Trials

• Site screening and site selection, including screening of clinical sites and selecting the site that is needed for running your clinical trial.

• Management of site throughout clinical trial period, including data and safety monitoring, site auditing and interim reporting to sponsors.

• Maintaining INDs and other FDA requirements.

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Data Management

• A capable and efficient management team that carefully manages your data.

• Timely data collection and robust analysis

• Database creation of your survey and other product/ingredient information

• Database storage.

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Clinical Trial Reporting

• Written summaries of clinical trials

• Clinical Reports/Case studies

• Manuscript preparation for academic journals

• Poster writing and reporting tools

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Medical Review Writing

• Literature reviews on your product/ingredients

• Clinical review on product ingredients’ regulatory status and compliance

• Evaluation of Raw Material Reference Database

• White papers and technical reports

• Efficacy summaries for business and marketing strategies

• Safety summaries and risk/benefit papers.