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Medical Writing

A key element of the clinical development process is effectively "telling the story", whether within the context of a clinical study report, a clinical development plan, an international registration dossier, or an original research article or state-of-the-art review. Our medical writing team is comprised of experienced clinical scientists/medical writers who are skilled at data interpretation and the clear and effective communication of scientific data to the target audience. Our clients benefit from the scientific background of our medical writers who possess extensive knowledge of the pathophysiology and treatment of diseases as well as an ability to rapidly assimilate new scientific information for novel technologies.

For clinical study reports and regulatory submissions, we advocate an integrated, multidisciplinary, project team approach including key members from the sponsor and CRO (and investigators or outside experts where applicable) who meet on a frequent basis from project initiation to completion. This project team approach harnesses the knowledge, experience, and insight of sponsor and CRO representatives and achieves superior results. Likewise, a coordinated approach between the sponsor, CRO, and investigators results in thoughtful and cogent scientific communications. In addition to their clinical research expertise, a number of our clinical scientists also have discovery and preclinical research experience. Our scientists have also established productive working relationships with analytical chemists, toxicologists, pharmacologists, and physician researchers which allows us to offer an integrated, turn key approach to the preparation of regulatory submission documents.