Pinnacle 21 Enterprise revolutionizes CRF design by providing real-time visualizations of how eCRFs will look and work for your EDC system – before study build begins! This innovative approach enables stakeholders to review, suggest changes, and approve designs efficiently, cutting review cycles in half.
Once approved, you can instantly build your EDC study with just one click, including all essential functionalities such as edit checks and visit structures.
Pinnacle 21 Enterprise offers a comprehensive solution for CRF designs and EDC builds, ensuring accuracy, efficiency, and compliance with CDISC standards. Its advanced visualization tools allow you to preview forms for your EDC system, and validate against EDC-specific rules.
When you design CRFs in P21E, our visualization tools give a preview of how forms will look and work for your EDC – even before you’ve built your study!
When you design and build studies in P21E, the platform validates against the rules of your chosen EDC, as well as against relevant CDISC rules.
Once CRF designs are approved, you can build a full EDC study directly from the P21E platform! This even includes full EDC specific functionality, such as edit checks and visit structures.
Our integrations mean you can build your study with the industry’s leading EDC systems – and even use multiple EDCs across relevant study phases. Plus, you only need to be familiar with the P21E platform to make use of different EDC systems!
Easily import existing content from your EDC into the P21E platform. Our integrations with Medidata Rave and Oracle Clinical One mean it’s just one click to import or export data between the EDC and P21E.
Once you’ve got CRFs designed and approved, you can standardize and store them in our clinical MDR for reuse across future standards and studies.
Being able to review and edit eCRFs in P21E – before EDC build – significantly shortens the typically long approvals process, and removes costly delays.
Our EDC integrations have helped pharmaceutical organizations cut review cycles from 8 days to 4. Others have reduced study build from 15 days to just 2! As a result, patient enrolment can start much earlier, and trials can get underway sooner.
Thanks to streamlined eCRF design/approval, together with automated EDC build, study setup is expedited, and lifesaving medicines can be brought to patients earlier.
Certara accelerates clinical trials by empowering you to design and build your EDC in under 6 weeks. With streamlined eCRF design and automated EDC build, trials can begin sooner, allowing lifesaving medicines to reach patients faster.
Our technical support team combines deep rooted knowledge of clinical data standards with decades of experience in clinical trial conformance. This expertise makes us the ideal partner to entrust with enhancing the speed and quality of your submission readiness.
Your data is safe with Pinnacle 21 Enterprise. Our platform complies with the highest industry standards to ensure data security and integrity.
Experience the transformative power of Pinnacle 21 Enterprise for CRF designs and EDC builds. See how our platform can streamline your clinical trial processes and accelerate timelines.
A CRF, or case report form, collects patient data during clinical trials, including personal information, vital signs, and responses to treatments.
An electronic case report form (eCRF) is a digital version of a CRF, used to collect and manage clinical trial data efficiently.
CRF design involves creating forms that align with study protocols to ensure accurate and relevant data collection for clinical trials.
Design CRFs to capture all protocol-specified information, ensuring clarity and relevance. Use Pinnacle 21’s checklist to avoid common mistakes.
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