Auxiliis project team is supported by our clinical writing team. We are committed to working with you according the EU/US/ICH guidelines and regulations, to deliver a wide range of high-quality clinical materials on time and in your style or format. We understand the importance of communicating the details clearly, concisely and accurately.
Proven clinical writing structure and philosophy
Our team has expertise to support a variety of clinical writing projects.
- PIP, Protocol Development
- Clinical Trial Applications, IND, IMPD, PIP in conjunction with our regulatory dep.
- Clinical Study Reports (CSRs)
- NDA, including Common Technical Docs (CTDs)
- Clinical Expert Reports
- Executive Summaries
- Journal manuscripts and Abstracts
Report writing is accomplished in collaboration with our statisticians, project managers and medical advisers in-house.