Where positive engagement and innovation meet integrity and quality
When it comes to clinical trial success, data integrity is key. With a world class technological infrastructure and a team of top managers and directors, SDC is committed to providing the highest data quality, integrity and security.
Through frequent coordination with clinical operations, SDC provides a seamless flow of data and a constant level of communication to ensure that projects meet deadlines and milestones, and keep clinical trials on track for timely conclusion. Our data management experts also fully understand and comply with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC) standards.
Whether the trial is a large international study or a single center proof of concept trial, SDC understands how crucial it is to get the project running efficiently. Clinical data management plays a key role from study startup through closeout and our team works seamlessly with clinical operations to meet all of the critical milestones of a sponsor's project. SDC consistently meets or exceeds sponsor expectations in regards to both timelines and quality.
SDC's data management support services include:
- Data Management Trial Master File Set-Up and Maintenance
- eCRF or CRF Design and Development
- Subject Diary Design and Development
- Data Management Plan Development
- Data Validation Manual Development
- Edit Check Programming, Validation, and Testing
- Clinical Database Creation, Validation and Auditing
- EDC System Training for Sites and Monitors
- CRF Tracking and Audit Trail Documentation
- Adverse Event, Concomitant Medication, and Medical History Coding
- Import, Integration, and Cleaning of Electronic Data (Lab, ECG, PK, Diary, etc.)
- Self Evident Correction Listing
- Continuous Data Cleaning Throughout Study
- Independent QC Review
- SAE Reconciliation between Safety and Clinical Databases
- 24/7 EDC Helpdesk
- Development of Custom Status Reports
- Query Reconciliation
- Database Lock