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Scientific
and Medical Writing
- Clinical trial
protocols and protocol amendments
- Extensive
library of clinical pharmacology study designs,
including special patient population studies
(e.g., renal impaired, hepatic dysfunction,
healthy elderly, thorough QT [TQT], radiolabeled
mass balance, ADME studies, etc.)
- “Off-the-shelf”
templates that have been vetted through multiple
phase 1 units
- Clinical study
reports (CSRs)
- Robust PK and PD
reports that can be attached to Clinical Study
Reports as an appendix.
- Our standalone
report structure has been used for multiple
studies and in numerous regulatory submissions.
The structure of the report allows for the
client to have an all encompassing PK, PD
document that highlights the most important
information but also contains all data needed
for reproducing the analyses.
- FDA and EMA
marketing applications including New Drug
Applications (NDA) and Biologics License Application
(BLA) including Common Technical Document (CTD)
components (e.g., CTD Module 2)
- IND application
preparation & maintenance,
- Full FDA IND
application preparation capabilities as well as
targeted efforts on clinical pharmacology, human
pharmacokinetics and pharmacodynamics, and
nonclinical ADME and toxicokinetic sections
- Investigator
brochure development and maintenance
- IMPD and
international regulatory documents
- Conference abstracts
and scientific posters
- SAE narratives
- Medical manuscripts
and medical journal articles
- General scientific
and medical writing
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