Versante has the expertise to develop protocols and create optimal study designs for drug research programs that extend from small dose-finding safety studies to large pivotal trials. Our personnel have the experience and the knowledge in all phases of clinical development.
The following is a summary of protocol development services
Consultation during protocol development
Use of adaptive designs
Determination of appropriate statistical methodologies
Development of Statistical Method’s sections for study protocols
Simulation studies to identify and define the best endpoints
Sample size and power analysis
Generation of randomization plans
Evaluation of key endpoints
Case report form design and completion guidelines
Client representation at regulatory meetings (INDs, NDAs)
Statistical Analysis and Reporting
Clinical Plan Development
Protocol Development and Study Design
Therapeutic Expertise Consultation
Data Management
Electronic Data Capture (EDC)
CDISC Conversion
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