A strong study setup is essential for the success of any clinical trial. Our team ensures that all foundational elements are carefully planned, programmed, and validated before the trial begins. From protocol review to system configuration, we align every detail with regulatory and sponsor expectations to ensure a smooth trial launch.
We manage eCRF programming, edit checks, role access controls, and key documentation like DMPs and annotated CRFs. Every step of the setup is handled with precision to ensure consistency, compliance, and efficiency throughout the study lifecycle.
- Protocol Review
- Project Plan & Timelines
- eCRF, edit check, role access control programming & validation
- Annotated CRF, Master CRF Casebook & ALS Generation
- Dictionary Setup (MedDRA, WHODD)
- Local Lab Setup
- User Acceptance Test (UAT)
- Study Documentation (DMP & DRP)
- eCRF Completion Guidelines
- Vendor Management (Agreement & Setup)
- IxRS Integration Setup, Validation & go-live