In the drug development phase the key factors impacting a pharmaceutical organization is the delay in timelines, the attrition rate of drugs in clinical trials and protocol noncompliance at various investigative sites. There is a need for the industry to identify and prioritize study design decisions and create robust and adaptive protocol designs which can help reduce the failures of clinical trials. Cognizant’s Collaboration Framework for Protocol Design (CFPD) solution is built on the Appian platform and provides robust processes, structure and collaboration to efficiently create the protocol design.
The key components of the protocol design is to capture the objective, material planning, process to be followed and reporting aspect of the trial. CFPD is aligned with these objectives as it follows the Target Product Profile (TPP) format defined by the Food and Drug Administration (FDA) which structures the protocol design covering key components of the trial design
- Explicitly translates the Target Product Profile or Target Product Claim to the study design which helps in building the Protocol Document in line with the FDA guideline.
- Provides traceability for each design decision for future references. All the comments and decision that each member provides is stored in the system.
- Initiates involvement of key decision makes early on in the creation of protocol design ensuring effectiveness in decision making.
- Generates a protocol design document as the output of the solution.
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