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Specialist in clinical
trial reporting.
We have experience
in:
- Study Reports, Phase I through Phase IV
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Population
-
Safety
-
Efficacy
-
Pharmacokinetics
-
Pharmacodynamics
-
Genotyping
-
Patient Profiles
-
and
more...
- New Drug Applications (NDA) to the FDA
- Supplemental New Drug Applications (sNDA)
- European Marketing Authorisation Applications (MAA)
- 4 Month Safety Updates (4MSU)
- Investigational New Drug (IND) Annual Reports
- CDISC data structures
- Electronic Submissions
- Clinical Investigator Brochures (CIB)
- Package Inserts (PI)
- Standardization of Reporting Efforts
- and
more...
Specialist in risk
assessment and survival analysis.
We have experience
in:
-
Trend tests for carcinogenicity
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Modeling for tumor onset
-
Simulations for tumor incidence and survival
- and
more...
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