Services:
Domain Consulting
Our consulting service to the Clinical Trial Industry, Contract Research Organizations, pharmaceutical and biotech companies and Laboratories include:
- Strategic clinical research program and study design
- Design of Risk Management Programs
- Product commercialization strategy
- Protocol development
- Case report form design
- Development of statistical analysis plans
- Statistical programming and biostatistics support
- Development of abstracts and manuscripts
- Medical writing
- Medical coding for Clinical Trials using MedDRA and WHO Drug dictionaries
- Site management and recruitment of Investigators
- Training in the domain of Clinical Trial Coordination, Monitoring, Auditing, Clinical Data Management, Medical coding, Adverse Event Reporting
- Regulatory compliance and Ethics Committee (Institutional Review Board) submissions and management
- eCTD submission support
- CDISC standards for Clinical Data Submission and migration of legacy data
- Off shoring of Clinical Data Management and related activities to Asia Pacific
- Out sourcing solution for Global Clinical Trials
- Adverse Event Reporting and Risk Management plans
- Post-Marketing Trials and retrospective analysis
Consulting services to the Hospital and Healthcare Space (Medical) include:
- HL7 implementation and messaging system
- ICD coding support
- Hospital Information System
- Digitalization of Healthcare records
- Work flow optimizations in Hospital administration
- Data and image archiving using DICOM and PACS data standards
- Patient Information System for hospitals
- Electronic Patient Records
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