Standardized Trial Protocols: Service and Toolkit for generation of trial protocols based on Transcelerate template

The pharma industry is generally considered as an expensive enterprise that requires considerable investments into the R&D activities with virtually no guaranties of return. Yet, many companies engage in these activities and try to maximize their outputs for the given R&D investments. Success of the conversion of the R&D investment into pharmaceutical products could be measured in the number of clinical trials that result from such an investment. The more clinical trials one company can initiate for the given R&D budget, the bigger the likelihood of those trials resulting in successful products.

The Transcelerate Common Protocol template (CPT) initiative focuses to further advance efficiency in clinical trials and accelerate drug development through the creation of a model clinical trial protocol template. The major potential benefits across stakeholder groups are: the ease of interpretation by sites and regulators, automation of downstream processes, shorter start up times at the sites and faster review by Health Authorities (HA), Ethical Committees (EC) and Institutional Review Boards (IRB).

Whether you are in the process of adopting the CPT or evaluating its usefulness for your trial or compound development, we have a practical solution for you.

intilaris Common Compound Toolkit offers trial sponsors an industry proven process and a toolkit to adopt the CPT and fully capitalize on having a common and structured protocol template. The toolkit applies the CPT, or any other template, to generate a draft clinical trial protocol aligned with your company’s standards. The intilaris Common Compound Toolkit provides you with:

  • Templates to capture the Compound Standards in a structured format
  • Capability to transfer trial-specific compound standards into CPT
  • Highlighting the standard content within the CPT compliant protocol
  • Structured and streamlined trial definitions that makes the critical information visible to the Clinical Trial team
  • Support for integrated processes from protocol to report (protocol, eCRF, analysis, reporting)
  • Configurable user based views of the important protocol elements in any word document template
  • Support for automation of downstream processes
  • Deliverables in compliance with CDISC, and customer specific, standards

We have extensive experience in building structured and standardized protocols for pharma organizations following the same principles that inspired the CPT initiative: to promote reusability, traceability, automation and end-to-end standardization. intilaris offers a solution based on CPT, or your template, that gives you:

  • An expert team specialized in compound standards and clinical standards
  • A industry proven process delivering continuity along the study planning in general and the protocol life cycle in particular
  • A Common Compound Toolkit, that increases end-to-end traceability and automates reuse of trial definitions

Would you like to know more?
To find out more on how our Common Compound Toolkit can improve your CPT adoption process, please contact us to arrange a demo of the toolkit at your convenience.