Whether for CE-mark, 510K, PMA or as a solid basis for product classification and study design; a critical literature review is an essential step that requires specific expertise and regulatory know-how.

More and more notified bodies and competent authorities are enforcing increased requirements and request in-depth reviews of literature in addition to or in lieu of prospective clinical investigations.

The D-TARGET Medical Writing/Safety department responds to the newly revised MEDDEV 2.12.4. guidelines with regards to vigilance reporting during clinical investigations and constitutes the key to successful and faster market access for all your products.

From final clinical reports, review and risk analyses, safety reports and summaries of pre-clinical results to publications and other essential documents, D-TARGET's clinical and technical experts add bottom line value to all your reports.

• Medical Writing Services
    • Critical Literature Review
    • Clinical report writing
    • Expert report writing
    • Abstract writing
    • Statistical calculations, analyses and reports
    • Articles

• Medical Safety Services
    • Vigilance systems & reporting
    • Complaint handling and classifications of clinical complaints
    • Adverse event coding
    • Safety reports
    • Setup of DSMB, ongoing management and reporting

For more information on Medical Writing and Safety Services, contact us today.