PhOSCo - the Pharma Open Source Community
PhOSCo AutoValidation

The biggest step change in EDC functionality since we delivered the first end-user EDC build tool, seven years ago.

Release 1.3 of PhOSCo will feature AutoValidation; the next step in integrated protocol design.

AutoValidation will cut down Trial preparation times by up to 50%. Yes, even on top of PhOSCo already being the quickest way to build Trials ever.

AutoValidation will eliminate testing errors.

AutoValidation will reduce Trial Protocol Customisation effort by up to 80%.

AutoValidation will deliver fully documented Validation and Audit at zero effort.

The Trial build process remains a simple, clinical end-user function; no programming. It now becomes a simple, integrated process from protocol specification through to test.

After any change in a Trial, a complete Regression Test and a complete Validation Test can be performed with a single button press. With full reporting and audit. With no extra effort.

The PhOSCo Metadata Database now stores at the Data Point level. Data Points can now be re-used individually in CRF Pages in as many trials as needed in the future. If you follow the simple Good Practice rules we give you, they should never need modification unless you change the specification, because of new customisation flexibility in Trial Builder.

These Data Points and CRF Pages will need validation one time only, regardless of how many Trials they are used in in the future.

A complete retest, revalidation, and validation report of a new Trial will take seconds. No redesign needed. No modification of test specifications. No manual testing. No manual documentation.

Don't confuse AutoValidation with automated testing. This is a step beyond even automated testing. With automated testing you have to define the test cases. This normally "front-loads" the testing effort; you take the pain once, early in the cycle, and gain the benefits if you have to re-test. In the case of Protocol Customisation Validation, using automated testing tools would actually take longer to get to first patient visit, but you'd gain in efficiency as you make changes to the Trial. It might help to a larger degree if you have a high rate of CRF Page re-use, but nowhere near as much as AutoValidation.

With AutoValidation, what you do is specify the Protocol. You have to do that anyway, right? AutoValidation is a Protocol Designer's tool to write concise, precise, Protocol specifications.

Once Trial Builder has the Protocol Specification, it can build the test cases itself. It can run the test cases itself. It can check the results of the test cases against the Protocol Specification. It can document the whole process for later QC audit. Guess what? That's just what Trial Builder 1.3 does.

It means that the Protocol and Trial Designers have a tool to help them do their creative job - designing and specifying the protocol, and building the rules to make sure that the job is done right. The computer does the repetitive mundane stuff that used to take all that time; does it quickly, effortlessly, efficiently, with no errors, and documents the whole process.

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