Pharma R&D and Real World Evidence Studies
Medical Writing
- Clinical Protocol / Investigation Plan development
- Informed Consent Form
- Investigator’s Brochures
- Study related Essential Documents
- Clinical Study Report
Country and Site Feasibility
- Country and site feasibility studies
- Country-mix and Site selection
- Protocol testing
- KOL consultation
- Patient advocacy consultation
Regulatory and Ethics Approvals
- Regulatory strategy and planning
- Document preparation for study submission
- Study submission to Local Ethics Committees
- Study submission to Competent Authorities and Central Ethics Committees
Clinical Monitoring and Project Management
- Local and Global Project Management
- Onsite and remote monitoring of investigational sites
- Partial and full source data verification
- Site and patient recruitment support
- Site Closure Activities
Biostatistics and Data Management
- Study design with sample size calculations
- Writing the Statistical Analysis Plan (SAP)
- Interim and final statistical analysis
- Paper and eCRF design and development
- Data Management
Data management
- Paper CRF and eCRF design and planning
- Development of CRF completion guidelines
- Development of Data Management Plan
- Database development, validation, and maintenance
- Data edit check planning and management
- Data validation and query management
- Medical coding
- Status report preparation
- Data Monitoring Committee services
Quality Assurance
- Performing independent site audits
- Inspection readiness activities
- Independent quality oversite assessment
Study & Site Start-up
- Investigator Meeting organization
- Budget and Clinical Trial Agreement negotiation and execution
- Conduction of Site Initiation Visits (SIV)
Vendor Management
- Experienced in selecting and managing third-party vendors
- Ensuring compliance with quality standards and service deliverables