Medical Writing

All Amarex medical writing projects are conducted in close synergy with our clients as well as the Amarex biometrics, regulatory affairs, and quality assurance departments.

Amarex medical writers are experienced scientists with advanced degrees in the biological sciences and related fields, affording them the experience to compile study-related data into comprehensive and understandable reports and submissions that are ICH/FDA compliant. A hallmark of all Amarex study reports and manuscripts is the use of reader-friendly graphics, supported by statistical tables and listings of trial data. A major timesaving advantage to Amarex clinical study reports is the preparation and client approval of a front-loaded shell early in the conduct of the trial.

Our medical writing professionals are experienced in word processing, graphics implementation, and document production. Medical writing experience includes all major therapeutic areas as well as pharmacology, immunology, infectious diseases, document assembly, filing and or
publication of research oriented documents.

Amarex Medical Writing Services:

• Integrated Clinical and Statistical Study Reports, Including Pharmacokinetics
• Statistical Reports
• Investigator Brochures
• Protocols
• Manuscripts and Abstracts
• U.S. and International Regulatory Submissions
• Safety and Efficacy Summaries
• NDA, ISS, ISE
• INAD, NADA
• BLE
• IDE, PMA