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Norwich Clinical Research Associates Ltd. (NCRA) Medical Writing Team produces Medical and Technical writing for all phases of your product's clinical research and development. Our writing teams support your Clinical Pharmacology, Clinical Operations, Data Management, and Biostatistics work. For clinical trials, our capabilities range from producing the Clinical Investigator's Manual, to development of the protocol, to completing the final report. We will provide you with a multidisciplinary team dedicated to your project, under the direction of skilled scientific writers/editors, to complete reports that meet your regulatory needs. Our writing team includes a Medical Monitor, ata management specialist, Clinical Research Assistant (CRA), Biometrician and scientific writer/editor. Our teams are experienced in working together with Sponsor teams to provide you with completed writing projects of the highest quality and integrity, efficiently and at moderate cost to you. NCRA's writing group produces cohesive, integrated biostatistical/medical reports. We can fulfill your outsourcing needs by completing your 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). NCRA's writing services go beyond report writing. Our other specialties include:working with investigators to write manuscripts for submission to scientific journals, helping you produce medical and scientific abstracts, creating posters and exhibits for meetings and conferences, producing product monographs geared to specific customers such as clinicians, patients, and formulary committees, and producing drug or device reference manuals. By letting NCRA complete your medical and technical writing projects, you will free up your own staff to focus on current strategic research and business needs.