NEMA Research, Inc.
NEMA Research Inc. is a leading clinical research organization specializing in drug development, offering a wide range of services from Phase I to IV trials. They focus on high-quality, practical solutions and have extensive networks of hospitals, physicians, and industry partners. Their mission is to provide innovative, cost-effective clinical research services while exceeding client expectations and ensuring compliance with regulatory standards.
Industries
Nr. of Employees
small (1-50)
NEMA Research, Inc.
Naples, Florida, United States, North America
Products
NEMA Scholars mentorship program
Program to mentor and assist early-career physicians and scientists in preparing and publishing their first papers in peer-reviewed journals.
Curated journal publication repository
Indexed list and access pathways for 300+ publications authored or supported by the organization, spanning multiple years and clinical topics.
NEMA Scholars mentorship program
Program to mentor and assist early-career physicians and scientists in preparing and publishing their first papers in peer-reviewed journals.
Curated journal publication repository
Indexed list and access pathways for 300+ publications authored or supported by the organization, spanning multiple years and clinical topics.
Services
Clinical protocol design and modification services for studies across therapeutic areas and phases.
Preparation and support for regulatory filings and communications including IND/PMA/505(b)(2) submissions, IRB processes, TMF management, and FDA meeting support.
CRA-led site selection, training, monitoring, initiation/closeout, regulatory document oversight, and drug accountability.
Physician- and nurse-led monitoring and consulting including SAE review, causality assessment, guidance on subject workup, and representation at regulatory meetings.
Dedicated project management covering planning, milestone tracking, cross-functional coordination, and senior management support for trial delivery.
Regulatory and scientific document preparation including investigator brochures, protocols, informed consent forms, clinical study reports, FDA briefing packages, and manuscript/publication planning.
Clinical protocol design and modification services for studies across therapeutic areas and phases.
Preparation and support for regulatory filings and communications including IND/PMA/505(b)(2) submissions, IRB processes, TMF management, and FDA meeting support.
CRA-led site selection, training, monitoring, initiation/closeout, regulatory document oversight, and drug accountability.
Physician- and nurse-led monitoring and consulting including SAE review, causality assessment, guidance on subject workup, and representation at regulatory meetings.
Dedicated project management covering planning, milestone tracking, cross-functional coordination, and senior management support for trial delivery.
Regulatory and scientific document preparation including investigator brochures, protocols, informed consent forms, clinical study reports, FDA briefing packages, and manuscript/publication planning.
Expertise Areas
- Clinical trial management (Phase I–IV)
- Regulatory compliance and submissions (IND/PMA/505(b)(2))
- Clinical monitoring and site management
- Medical monitoring and safety oversight
Key Technologies
- Electronic data capture / eCRF
- Clinical database development and deployment
- Electronic informed consent (eConsent)
- Electronic diaries and remote patient-reported assessments
News & Updates
Announcement of new scholars supporting young physicians and scientists in publishing their first papers.
Submission and acceptance of NEMA Scholars' research on stress levels in high school vs. university athletes.
Event at NEMA's headquarters in Naples, Florida.
Enalare and NEMA Research selected as finalists for the 2023 award.
NEMA Research named to shortlist for excellence in innovation and COVID-19 response.
Neumentum and NEMA Research named to shortlist for 2021.
Announcement of new scholars supporting young physicians and scientists in publishing their first papers.
Submission and acceptance of NEMA Scholars' research on stress levels in high school vs. university athletes.
Event at NEMA's headquarters in Naples, Florida.
Enalare and NEMA Research selected as finalists for the 2023 award.
NEMA Research named to shortlist for excellence in innovation and COVID-19 response.
Neumentum and NEMA Research named to shortlist for 2021.