|
- CRF Design for Phase I - III studies of gastrointestinal, urinary,
and anesthetic drugs.
- Database Integration of existing studies (speadsheets, ascii files,
and paper CRFs) and planned studies into integrated safety (ISS) and efficacy (ISE) SAS datasets for NDA filing.
- Data Entry Software design and implementation of SAS-based system with
an EP90 front-end for client use.
- Statistical Analysis Plan review for global NDA filing of 82 international
studies in post-operative settings.
- Statistical Analysis of efficacy and safety for combination therapy
for hypertension.
- Presentation Preparation for professional associations, including American
Urological Assocation, Royal Academy of Science, American Public Health Association, and European Congress of Allergology
& Clinical Immunology.
- Custom SAS programming for client presentations or data integration.
- Coding of medical terms, including migration of legacy data to MedDRA.
- Validation / Hazard Plan assessment, remediation, testing and implementation.
How can we help you?
Contact us by email
or phone (847) 458-2900
|
