The overall timeframe of the configuration process takes between 8 and 12 weeks from content finalization, and it is managed by highly skilled and experienced clinical data managers who possess, on average, 5-7 years of life sciences experience. Clinical data managers lead a team representing the following functions:
- Database management
- Information technology
We take a phased approach to planning, configuring, and deploying the ePRO/EDC solutions. Our seven (7) phases ensure accurate “discovery” and requirements gathering, as well as information sharing and complete transparency with the project teams.
Consistent with our existing processes, we propose the following seven phases, many of which occur concurrently, during our partnerships: 1) Planning; 2) Configuration; 3) Data Migration; 4) Training; 5) Documentation; 6) Deployment (Live); and 7) Production Support.
Specifically, implementations typically follow a well-defined process, as outlined below:
Customer and Clinipace Worldwide teams collaborate on creating four specification documents. The data and edit specs are spreadsheet documents and represent the variables [fields], variable type, values, order, and validation rules. The workflow and reporting specs are text documents and represent the inter-relationship between forms, field/form behavior, form flow, branching, and reporting data and layout.
Completing the specs is a collaborative process and the completion time frame is completely dependent on how motivated the customer is in completing the process and their ability to communicate how they want to operationalize the project protocol. Within this collaborative process, the customer owns the “content” of the specs and we work with them to complete the actual specifications in required format, if needed.
Once the “content” is completed the configuration of TEMPO™ can begin. Configuration can occur concurrently with spec creation [and we can iterate with the customer], BUT, at a minimum, a draft of the data spec must be complete. The configuration tool transforms the spreadsheet-based data [variables & values] and edits [validation] specs into a CDISC ODM compliant XML file which defines the database schema. The output of this process is an XML file that is CDISC ODM compliant. This step typically takes place during the first 2 weeks after “content” from the specification process is complete [step 1].
The Admin tool accesses the CDISC ODM compliant XML file to automatically build out the database and forms. The Admin tool connects to the TEMPO™ infrastructure - reading/writing data to both the database and application server. In addition, workflow processes and rules are configured [we call them “acts”], site & user accounts are created/managed, and reports are defined and built within this tool. Technically, the Admin Tool simply acts as a middleware layer that enables our professional services team to configure and administrate the TEMPO™ platform. Steps 3 through 5 typically occur during weeks 3-12 of the set-up and deployment process.
The TEMPO™ environment is built and ready for customer feedback. In the preceding step the database is built, workflows are defined/configured, sites & users are created, and reports are activated.
Based on customer feedback, changes can be made very easy and TEMPO™ can be quickly re-configured. During the iterative process, changes to the forms [variables, layout, values, data validation, etc] are made within our system tools, a new XML file is generated which is then acted upon by the Admin tool. This process continues quickly and is transparent to the customer. The output of this step is a platform that is ready for user acceptance testing [UAT].
If any issues arise during UAT, changes are made and the testing continues until the UAT document is signed. The output of this step is TEMPO™ is released to production [RTP]
TEMPO™ is ready for use!