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.
