Phase I study design and conduct is critical to the continuation of drug development. 

Our company has extensive experience with protocol design, conduct, analysis and interpretation of data from multiple types of Phase I studies.  Attention to every detail is crucial to avoid missteps in your clinical studies.

Once complete, our analysis and interpretation of the results within the context of your overall drug development program is key to designing and implementing the next phases of study.

 

Clinical Phase I - Study Design and Conduct Services include

• Clinical pharmacology strategy development/review

• Study design, protocol and CRF development

• Study startup activities

• Data management (eCRF, randomization, database build, edit check, etc.)

• Robust PK analysis and standalone PK Report

• Biostatistics

• Clinical study report (CSR)

• Study management

• Clinical monitoring

• Medical monitoring

• CDISC datasets

• Documents that are eCTD-publishing ready

• Post-study update, if necessary, to clinical pharmacology strategy

• Medical monitoring

• CDISC datasets

• Documents that are eCTD-publishing ready

• Post-study update, if necessary, to clinical pharmacology strategy