Clinical Data Management
Managing Clinical Data in the existing complex regulatory scenario is the most challenging task. With R&D costs spiraling upwards, patents expiring on many molecules and stringent FDA requirements for new drug approval, it is imperative that there is need to reduce time-to-market and minimize costs.
At Synmeta LLC, we understand clinical data management challenges. We offer end-to-end clinical data management solutions integrating technology and clinical data expertise, supported by a robust quality management framework to deliver high quality data.
Our Services
Synmeta LLC offers end-to-end clinical data management services which include:
- pCRF/eCRF Design
- Database Design and Programming
- Database Testing and UAT
- Data Migration
- Data Loading
- Scanning and Indexing
- Data Entry
- Data Review
- Laboratory Data Management
- SAE Reconciliation
- Medical Dictionary Coding
- Quality Control Activities
- Database Lock
- Archival
Clinical Data Management services offered for paper based studies include:
- CDM Project Management
- Case Report Forms (CRFs) Design
- CRF Annotation
- CRF Completion Guidelines
- Data Management Plan
- Clinical Database Design and Deployment
- Edit Check Programming and Testing
- CRF Scanning and indexing
- Double Data Entry and Verification
- Query Management and Resolution
- Clinical Data Validation & Quality Assurance
- Medical Coding (MedDRA and WHO-DD)
- Handling of External Data
- Generation of System Reports and Data Listings
- Serious Adverse Events (SAE) Reconciliation
- Interim and Final Data Transfers
- Filing and Archiving, we understand clinical data management challenges. We offer end-to-end clinical data management solutions integrating technology and clinical data expertise, supported by a robust quality management framework to deliver high quality data.