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Medical Writing
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Synteract's Medical Writing group consists of PhD's and other advanced degreed individuals
with a wide range of clinical trial experience to ensure that your clinical program is well
designed to meet its goals and objectives while being technically solid. Whether this is the
first clinical protocol, a pivotal trial protocol or the associated documents such as the ICF,
the Investigational Brochure or the full IND/IDE; the appropriate medical and clinical expertise
is brought to bear in the writing process to insure the success of your project from this critical
start-up design phase.
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Similarly, at the end of the day, this experience and expertise is utilized in pulling all the
results together for clinical presentation and regulatory approval. Whether its the Clinical Study
Report or the complete NDA/SNDA , MAA, PMA or 510(k) or sections of these such as an ISS or ISE,
the appropriate design and organization of these documents will facilitate and expedite the Regulatory
approval process.
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Synteract's Medical Writing group also has extensive experience in the other aspects of the clinical
writing process including manuscripts for all tier level journals, where balance of medical and marketing
become key, expert reports, posters and other related clinical trial development documents as necessary.
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Medical Writing Services
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- Case record form design
- Standard Operating Procedures
- Summaries of safety and efficacy
- Clinical study reports
- Expert reports
- Manuscripts and posters
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