Structured Protocol & Clinical Document Authoring
One million dollars a day is lost when companies’ delay their submissions for product approvals. The single largest delay in starting a clinical trial is the development and approval of the Protocol and amendment; processes which support the development and management these critical documents are key to their successfully mitigating the risk. Our experience shows that the business processes governing protocol development are an area of significant opportunity to reduce the cycle times for this document. The application of standards and meta-data to scientific and operational information; combined with rigorous business processes management is the first part of the solution. The second part of the solution is the development and implementation of IT systems, which optimize and facilitate the business process with user-friendly interfaces.
Paragon understands the criticality of the Protocol document and leverages it development though our unique accelerators:
- Intelligent content s to streamline operational efficiency and improve quality of paper-intensive protocols.
- Business process maturity models which will help you understand where your business opportunities lie and how far they need to change.
- Systems evaluation tools (to take you from FRI to FRS)
- Capability roadmap to define knowledge and skill gaps and needs
- Change management programs, to ensure progression is evolutionary, not revolutionary.
Structured Protocol Authoring