Our Partners
Service Provider
We provide full-service clinical trial support across the development lifecycle — from protocol development to regulatory submission.
Study Setup & Planning
We provide IT and non-IT programming services in the following areas.
- Protocol Review: Understand the study objectives, endpoints, visit schedules, and data requirements.
- CRF Design (Case Report Form):
- Design CRFs based on protocol requirements.
- Use eCRF tools compatible with Oracle Clinical (e.g., RDC or InForm).
- Ensure CRFs are user-friendly and capture all necessary data points.
- CRF Annotation:Map each data field in the CRF to the corresponding database field (metadata annotation).
Database Design in Oracle Clinical
- Study Definition: Define study-level parameters like visit schedule, treatment arms, and sites
- DCM Creation (Data Collection Modules):
- Create modules for each CRF page in Oracle Clinical.
- Define data fields, formats, validation rules, and derivations.
- DVG (Data Validation Group) Setup: Implement edit checks and validation logic to flag data discrepancies.
- Global Library Integration (if applicable): Use standard CRF modules and edit checks from centralized libraries to ensure consistency.
eCRF Build & Integration
- eCRF Development: Use tools like Oracle RDC or InForm to build the electronic CRFs.
- Integration with Oracle Clinical:
- Link eCRF data entry to Oracle Clinical backend
- oEnsure real-time or batch data flow from front-end to Oracle Clinical.
Testing & UAT (User Acceptance Testing)
- Edit Check Testing: Validate that all edit checks, queries, and logic work as expected.
- CRF Navigation & Workflow Testing: Test user experience, data flow, and system response.
- User Acceptance Testing (UAT): Conduct final testing with stakeholders (data managers, CRAs, etc.) before go-live.
Data Entry & Validation
- Site Data Entry: Sites enter data into eCRFs through the front-end system.
- Data Validation:
- Auto-queries raised by system edit checks.
- Manual review by Data Managers.
- Discrepancy management and query resolution.
Data Cleaning & Reconciliation
- Ongoing Review: Regular data reviews for completeness, consistency, and accuracy.
- External Data Reconciliation: Match lab, ECG, or other external data with eCRF entries.
- SAE Reconciliation: Ensure consistency between SAE (Serious Adverse Event) reports and safety databases.
Database Lock & Archival
- Final Review: Ensure all queries are resolved, and all data is clean.
- Database Lock: Freeze the database to prevent further changes.
- Archiving: Archive the database and associated metadata (CRFs, audit trails) per regulatory guidelines.