To ensure optimal protocol creation and utilization, it is essential that the protocol data is easily accessible and flows smoothly through processes and systems supporting clinical trials. At HERAX, we can help you and your organization in assessing the electronic protocol system landscape both for processes and technology, and selecting the right solution for your study.
Digitalizing the protocol and enabling automatization can be challenging. We provide guidance in this phase, through process optimization, metadata standardization, vendor selection and implementation of the best eProtocol tool for your organization.
Outlining the processes for protocol development and further use is an important step towards pinpointing the optimization areas e.g. metadata standardization, and for implementing full digitalization of protocol creation, standardization, and data utilization.
Pharma- and biotech companies will benefit from:
- Streamlined protocol development process
- Fully digitalized protocol
- Utilization of protocol data to populate critical clinical downstream systems
- Easier collaboration between authors and reviewers
- Reduction in redundant protocol content
- Enabling of therapeutic area standards
- Protocol feasibility analysis
- Improved conduct of the study and quality of data collected
- Content libraries, best practices and reuse of content
- Overview of protocol creation via task management and workflows
- Protocol metrics to keep track of development, and to be used for further optimization
Our eProtocol Services
At HERAX, our consultants have extensive knowledge in the clinical space. The understanding of the trial initiation and execution process provides a solid foundation for performing assessments of the optimal protocol development process using data standards, creating electronic workflows, machine readable protocol data, etc. This is ideal for creating new protocol authoring processes, for supporting a potential vendor selection and to ensure optimal utilization of protocol data in downstream clinical systems.
Your partners in implementation
For your organization that means fully systemized eProtocol creation, optimal and automatic use of protocol data in downstream systems e.g. EDC, MDR, SC etc., controlled electronic review workflow and a shorter time from clinical development plan to final protocol and FPFV.