Every study or trial is unique. At Prelude Dynamics, our process begins by working closely with you to understand your unique needs and requirements. Using study documentation, such as the protocol and/or paper CRFs, and discussions with your team of clinical experts, we flush out an initial design of the electronic system. We use personal interaction to ensure that we have fully understood your requirements and are providing the most efficient and complete solutions.
Once we have received the initial details, we build the electronic Case Report Forms (eCRFs) along with multiple edit checks and summary charts that give your study a streamlined and sturdy foundation. If you have previously designed paper CRFs, we will customize and implement forms that closely resemble your paper pages to shorten the training and learning process. The Study Build is an iterative process so we are in constant contact with you and your team. Using our internal “Feedback” tool, you can communicate changes and needs to your Prelude Project Manager. Specialized tailoring of the system and visual adjustments will then be made to make the system and tools yours.
User Acceptance Test
When the Study Build is completed and validated on our end, we deploy the final build for your team to verify that the end product and functionality meets and exceeds your expectations. We also provide a Study Requirements Document (SRD) that describes the forms, data elements, summary charts, and edit checks that apply to your study. This part of the process involves much collaboration and discussion. Any problems are quickly fixed and small adjustments are made before the system is redeployed and accepted.
We offer training (Train the Trainer method) web-based or in person, based on convenience or preference.
The final Study Build is loaded onto a dedicated server. At this time, user accounts are established and your clinicians can begin the training for the trial using a duplicate site 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 ultimate data traceability and site control. In addition, your dedicated Prelude Project Manager and our software architects are ready to assist you and answer any questions as you progress. Ad-hoc searches and reports can be run at any time directly within VISION™. Any or all data can also be exported from VISION™ mid-study for early statistical analysis. Monitors can enter real-time queries directly on the data entry field, making manual data cleansing a thing of the past.
We can all safely agree it is virtually impossible to anticipate every data element and edit check in advance. 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. Our “revalidation” feature 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.