Standard Company Process when Working with Clients
Our process begins by understanding your unique needs and requirements. Using study protocol and discussions with your team of clinical experts, we write a Study Requirements Document (SRD) that describes the functionality, forms, data elements, summary charts, and edit checks that apply to your study. We use personal interaction to ensure that we have fully understood your requirements and are providing the most efficient and complete solutions.
With your approval of the Study Requirements Document, we build the electronic Case Report Forms; along with multiple edit checks and summary charts that give your study a streamlined and sturdy foundation. If you have designed paper CRFs, we will customize and implement forms that closely resemble your paper pages. Specialized tailoring of the system and visual adjustments will then be made to make the system and tools yours. The customized system is then thoroughly tested and validated.
User Acceptance Test
When the study build is completed and validated, we deploy the results for your test team to verify that the end product and functionality meets and exceeds your expectations. Any problems are quickly fixed and small adjustments are made before the system is redeployed and accepted.
The final working system and study build is loaded into a dedicated server. At this time, user accounts are established and your clinicians can begin the training for the trial using a duplicate training database. Training shifts to the real database when you are ready by a simple reassignment of the users. You immediately begin to see the benefits as your study progresses. Your data is stored in a Tier 1 facility that provides the ultimate in protection and security.
For the life of your study, we provide backups and archives of your study data to guarantee the ultimate in data traceability and site control. In addition, help desk personnel and our software architects are ready to assist you and answer any questions as you progress.
We can all safely agree it is virtually impossible to anticipate every data element and edit check in advance. Furthermore, as the study progresses, the trend charts may indicate additional information that would be advantageous to collect. Our elegant architecture facilitates addition to and change of data elements, edit checks, and summary charts with an ease unparalleled in traditional or competing software systems. In addition, Perceptive Connection offers a "revalidation" feature that allows data managers and other study personnel to change the edit checks and have the system automatically reprocess all forms for checking.
At the end of the study, we make a final archive and decommission the study, removing the study data and user accounts. The archived data is sent to the sites and the client.
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