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 establish 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 issues are quickly fixed and small adjustments are made before the system is redeployed and accepted.