CRF design & EDC build in Pinnacle 21
Do CRF designs & build your EDC in under 6 weeks
With our CRF design, visualization & study build engine
Design CRFs and preview how they’ll look for your EDC – without having to build your study! With a true visualization of your CRFs in Pinnacle 21 (P21), stakeholders can provide changes and approvals, before the EDC is built!
That way, once CRFs are approved, you’re just one click away from building your EDC study from Pinnacle 21.
Cut CRF review cycles and gain approvals in half the time!
Why do CRF designs in Pinnacle 21?
Preview CRFs before EDC build
When you design CRFs in P21, our visualization tools give a preview of how forms will look and work for your EDC – before you’ve built your study!
Validate against your EDC
When you design and build studies in P21, the platform validates against the rules of your chosen EDC – as well as against CDISC rules. That applies if you’re using multiple EDCs for different study phases.
Instantly build your EDC
Once CRF designs are approved, you can build a full EDC study directly from the P21 platform! This even includes all your EDC specific functionality, such as edit checks and visit structures.
Use multiple EDCs
Our integrations mean you can build your study with multiple EDCs – for example, using the relevant EDC for each study phase. And the best thing is, you only need to be familiar with the P21 platform to use different EDCs!
Import & export EDC content
Easily import existing content from your EDC into the P21 platform. Our full integrations with Rave and Clinical One mean it’s just one click to import or export data between the EDC and P21.
Standardize & reuse CRFs
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.
See how to build studies in under 6 weeks with our EDC integrations
Why you’re better off with P21
Faster approvals
Being able to edit/review eCRFs in real-time in the P21 platform – before EDC build – massively shortens the long approvals process. No more delays going back and forth between stakeholders. Just live updates and efficient approvals!
Patient enrollment starts earlier
Our EDC integrations have helped organizations cut review cycles from 8 days to 4, and reduce study build from 15 days to just 2! As a result, patients can be enrolled in trials much earlier so trials can start sooner than ever before!
Speed drugs to market
With a headstart on study set up, trials can get underway earlier than was ever possible before. As a result, lifesaving medicines can be brought to patients earlier – thanks to streamlined eCRF design and approvals, with automated EDC build.
Build your EDC in 1 click!
What people say about us
Pinnacle 21 and Formedix have joined forces!
Our unified platform will improve collaboration and data flow across key stakeholders, whilst enabling faster, higher quality trials, from design to submission.
Find out more about ryze > visit formedix.com
Find out more about P21 > visit pinnacle21.com
Resources
CRFs FAQs
A CRF is a case report form in clinical trials. A CRF is used to collect data from patients participating in clinical studies. It records personal information, such as age, weight, and height, as well as the patient’s response to medicines being trialed. For example, the case report form collects data about any adverse events (AE), such as symptoms related to the use of a drug, and vital signs data (VS), such as blood pressure and temperature.
The terms, case report form and electronic case report form are used interchangeably in clinical trials, as are their abbreviations, CRF and eCRF. Traditionally, case report forms, or CRFs, were paper based and electronic case report forms, or eCRFs, were digital forms. However, both terms are currently used to refer to the same thing. Here’s an example electronic case report form.
CRF design or eCRF design refers to the process of designing your electronic case report form, in line with the requirements of the study protocol. Effective CRF design is essential in ensuring that the correct, relevant information is collected in a clinical trial, in order to give a study the best chance of success.
When designing a CRF, the form must capture all of the required information specified in the study protocol. In other words, the case report form design should match all the points listed in the final protocol, so that the objectives of the protocol are met. The CRF design should be clear, easy to understand, and should collect only the required information, nothing more.