Services
Clinical Trial Design and Implementation
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Medical review, evaluation and guidance for the development
of clinical development plans, protocols, clinical study
reports and other study-related documents and scientific
communications
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Design and develop study documents including but not
limited to
- Case report forms (CRF)
- CRF Completion Guidelines/Instructions
- Study Monitoring Guidelines
- Study Manual
Safety Surveillance
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Verifying the medical accuracy of patient safety data and
maintaining an ongoing assessment of the safety profile of
the study
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Monitoring of early safety data and key efficacy data
Medical Data Coding
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Medical coding of data from ongoing studies using MedDRA and WHO-DRUG
dictionaries
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Re-coding of medical data using MedDRA, to bring data coded in COSTART,
WHO-ART, ICD – CM or other dictionaries to current international standards
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Provide expert advice on complex coding cases
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