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Norwich Clinical Research Associates

Clinical Monitoring, Auditing, and Data Management Services

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Norwich Clinical Research Associates

NCRA specializes in pre- and post-market studies for bringing investigational products to market and providing the necessary support once cleared / approved. NCRA is especially skilled in product development consulting, clinical monitoring, auditing, and data management services uniquely suited for the pharmaceutical, nutraceutical, medical device and biotech industries.

Additional services NCRA provide are statistical analysis, processing and writing final reports and regulatory documents, assistance with developing standard operating procedures, plus training on conduct and monitoring of regulated clinical trials. NCRA conducts in entirety small-to large clinical trials from protocol design to completion of the final reports for regulatory submission. The company’s associates are experienced in preparation and completion of FDA regulatory applications.

Clindex® Clinical Trial and Data Management System

NCRA is highly experienced in providing GCP Audit and Data Review services customized to meet your project-specific needs. NCRA Data Management team’s main mission is to provide clients with accurate, validated data rapidly and at competitive cost. NCRA is extremely capable, providing swift and efficient ways to collect and handle data using cost-effective technology to serve the systems and data-management needs of our clients. One of the primary tools that NCRA uses, the Clindex® Clinical Trial and Data Management System, can accommodate hard copy or electronic data capture, specific to the client’s needs. This system not only provides excellent data management capabilities but also a comprehensive trial management system that allows the client to efficiently keep up on study status.

Product development consulting

NCRA combines the best of our academic and industry clinical research experience to provide our clients with professional product development consulting. NCRA can conduct your pre- through post-market trials to assist you in making the most of your trial results. We are very experienced with working closely with the FDA to ensure your product development meets all applicable FDA regulations and that you, NCRA, and the FDA are working together as a team to get your products approved in the most efficient and timely manner possible.

NCRA’s individual disciplinary teams conduct and complete any or all segments of clinical trials:

  • Product development consultants
  • Medical monitors
  • Clinical research associates
  • Data management and database development/programming professionals
  • GCP and other auditing professionals
  • Statisticians
  • Medical/technical writers

Norwich Clinical Research Associates Ltd.
74 East Main Street
Norwich
NY 13815

Tel: 1-800-607-6272
Fax: 1-607-336-6318
ncra@ncra.com
www.ncra.com

Quick Contact Norwich Clinical Research Associates


Auditing-Data Review

NCRA is highly experienced in providing GCP Audit and Data Review services customized to meet your project-specific needs. Whether it involves establishing a data safety monitoring board, assessing existing programs for managerial acquisition decisions, performing internally motivated quality service or pre-application submission audits, or responding to an FDA data audit request, NCRA is able to provide you with the specialized assistance you require.

We understand the time constraints placed on such projects and have the expertise necessary to get your project up and running quickly and completed within the tight timelines that such projects require. NCRA's Auditing teams are dedicated to providing exceptional and timely service. In order to do so they provide: Experienced auditors/reviewers and auditing/reviewing teams,…

Clinical Operations

NCRA's experienced Clinical Operations teams are ready to conduct and/or manage whole or specific parts of your clinical trials. Our integrated teams include members from Clinical Operations, Data Management and Medical Affairs.

Pharmaceutical, biotech, medical device manufacturers, and contract research organisations that implement integrated, electronic systems to manage their clinical trial processes gain the advantage of real-time tracking, effective control, and proven, repeatable processes. As a result, leading companies are implementing enterprise clinical trials management systems to improve the tracking and oversight of clinical trials processes.TrackWise Clinical…

Data Management Services

NCRA Data Management team's main mission is to provide clients with accurate, validated data rapidly and at competitive cost. NCRA is extremely capable, providing swift and efficient ways to collect and handle data using cost-effective technology to serve the systems and data-management needs of our clients.

One of the primary tools that NCRA uses, the Clindex® Clinical Trial and Data Management System, can accommodate hard copy or electronic data capture, specific to the client's needs. This system not only provides excellent data management capabilities but also a comprehensive trial management system that allows the client to efficiently keep up on study…

Medical Writing Services

NCRA's Medical Writing Team produces medical and technical writing for all phases of your product's clinical research and development. For clinical trials, our capabilities range from producing the Clinical Investigator's Manual/Investigator's Brochure/Report of Prior Investigations through development of the protocol, to completing the final report.

NCRA's writing group produces cohesive, integrated statistical/medical reports. We can fulfill your outsourcing needs by completing: Outstanding or delayed study final reports Investigational new drug application (IND) and new drug application (NDA) submissions Investigational device exemption (IDE), 510(K) and pre marketing approval (PMA) submissions International product licensing applications (PLA)

Product Development

The central range of SOLVOTEC is the design and development of new products or their components.

We have experience in development and product support articles and in particular from the sectors medical engineering, precision mechanics and optics, and consumer goods. We see ourselves as an "extended workbench" of our clients. We prepare feasibility studies, installation concepts and FMEA and design as well as tolerate the parts for the respective manufacturing processes…

Statistical Services

NCRA offers a complete line of statistical analytical services ranging from early trial planning to final analysis, and review and reporting of the results of your clinical trials through the integration and submission of trial data for your regulatory applications.

Our statisticians are industry experienced and have supported product research, development and marketing. NCRA's statisticians bring this experience to our teams and to your projects, providing you with services of the highest quality. We pride ourselves on our history of delivering clear, accurate, understandable statistical work. By working in parallel on blinded but real data…

Therapeutic Expertise

A list of NCRA's therapeutic areas.

NCRA therapeutic areas of experience include: Cardiovascular Anti-arrhythmics Aortic aneurysm Ischemia Heart failure Anti-hypertensives Hyperlipidemia Coronary occlusion Radiofrequency ablation device NIBP AAA stent Implantable cardiac defibrillators Cardiac artery occlusion/angioplasty Artificial heart valves Vital signs monitor ASD closure PFO closure Dermatology Allergy Psoriasis Rosacea Endocrinology Calcium metabolism disorders – hormone, parathyroid, and hypercalcemia ENT Otoscopes Gastrology…
Quick Contact Norwich Clinical Research Associates
Quick Contact Norwich Clinical Research Associates


Quick Contact Norwich Clinical Research Associates
Quick Contact Norwich Clinical Research Associates
Quick Contact Norwich Clinical Research Associates


Contact Norwich Clinical Research Associates

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