Common Protocol Template Implementation
The Common Protocol Template (CPT), published by TransCelerate harmonizes and streamlines the content of clinical trial protocols. The main goal achieved by the template is to facilitate the work of the investigators, sites and regulatory authorities in interpreting the protocols. At the same time, the CPT enables better downstream process automation and clinical data standards alignment. Supporting your Common Protocol Template implementation, intilaris ensures you experience a seamless transition.
With our focus on process optimization and structuring of the clinical trial protocol development process, intilaris is excited to have been supporting organizations in their transition from a company specific protocol template to the CPT. This transition process is not a simple one as it requires careful alignment with the new template of all cross-organization stakeholders as well as ensuring the alignment of the future capabilities of the organization to implement the Digital Data Flow initiative.
For an in-depth conversation on this topic, please reach out to us.
Need for change
Clinical trial protocols accelerated increase in complexity results in difficulties for the protocol stakeholders to implement, report and review on clinical trials across sites. The issue is enlarged by the apparent lack of consistency across protocols. If investigators, regulators and patients have consistent structure, look and feel of a clinical trial protocol presented to them, it greatly enhances the understandability of the protocol as well as the compliance to it.
Once the common protocol template implementation for trial planning, design and protocol authoring is in place, the organization can start integrating and simulating the information flow and parallelize the downstream process execution for better operational efficiency.
Furthermore, the CPT is a step in the right direction regarding the longer-term vision of an electronic, machine-readable protocol, consumed by all downstream processes of the sponsor. Ability to consume the standardized content, ensures that clinical trial protocol document stay aligned with other core clinical trial documentation such as the statistical analysis plan.
Supporting your common protocol template implementation
Intilaris has been supporting the adoption of the TransCelerate common protocol template in the pharma industry through our process optimization of the clinical trial protocol development process.
We ensure that the impact of the change is properly evaluated and that the organization transitions to the CPT in a guided and structured approach with proper cross-functional alignments including:
- Clinical Leaders
- Clinical Project Management
- Medical Writing
- Clinical Standards
Furthermore, we support your organization in establishing a clinical trial protocol and design center of excellence for streamlining trial planning and execution.