Avania
Medical Writing Services
FromAvania
Our experienced team of therapeutically aligned medical writers support your product development by optimizing your presentation of clinical information with a wide variety of medical and scientific documentation. Our flexible services are available as part of your comprehensive program or as stand-alone assignments.
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Avania’s expert medical writing team compiles, organizes, writes, edits, and produces documentation for:
Study design
- Extensive expertise to help you plan an optimal study design
- Direct market feedback through meetings with panels of clinical experts
- Access to the key opinion leaders and surgical experts throughout the U.S. and Europe
Postmarket surveillance and clinical follow-up
- Postmarket surveillance (PMS) plan and/or a postmarket clinical follow-up (PMCF) plan in line with FDA, TGA, and Medical Device Regulation (MDR) requirements
- Annual reports
Clinical evaluation
- Accurate, timely clinical evaluation plans and reports (CERs)
Study results reporting
- Medical writers with in-depth knowledge about standards in the U.S. (21 CFR), Europe (ICH E6), and Australia (ISO 14155)
- Expert guidance regardless of if studies were performed in both the U.S. and EU or if data is submitted to the FDA, TGA, and a notified body
- Pre-regulatory meeting briefing documents
- Preclinical study reports, expert reports, and summaries
- Benefit-risk assessment reports
- Patient narratives
Scientific literature
- Highly skilled, systematic medical and scientific literature reviews for any topic
- Abstract, manuscript, and journal article creation
Investigator’s brochure
- Extensive experience in premarket clinical trials to guide your investigator’s brochure and ensure alignment with regulatory standards