Request for Proposal
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Submit NowPhase I – IV Clinical Trials
Accelerating your Clinical development programs
With an experienced team working under an accomplished Clinical Project Manager, everything is planned, implemented, and executed in line with regulatory requirements and sponsor’s expectations from onset through the entire clinical trial process.
- Protocol Synopsis
- Protocol
- Investigator’s Brochure
- IMPD
- Informed Consent Form
- Patient Narratives
- Clinical Study Report
- Clinical and Nonclinical Summaries
- Pre-Submission Preparations (e.g., pre-IND, etc.)
- Regulatory Strategy
- Pre-Submission Preparations (e.g., pre-IND, etc.)
- Global Regulatory Submissions
- IRB, Local and Central Ethical Committee Submissions
- Regulatory Reporting
- Global Program Coordination and Oversight
- Project Transition and Rescue Management
- Vendor Mobilization and Management
- Project Plans
- Investigator Meetings and Training
- DMC Support
- Site Feasibility and Qualification
- Site Contracting and Payment Administration
- Site Initiation, Monitoring and Closeout
- Central, Remote, and Virtual Clinical Trial Monitoring
- Risk-Based Monitoring
- Site Audit Support
- Medical Support and Guidance
- Protocol and Plans Review
- SAE/SUSAR Review and Assessment
- Medical and Clinical Data Review
- Database Build, Validation, and Testing
- System and User Management
- Data Cleaning and Query Management
- Database Reconciliation and Lock
- CDISC Standardization
- Statistical Programming and Analysis (Tables, Listings, and Figures)
- Adaptive Designs and Power Analyses
- CSR, ISS/ISE, DSUR, etc. Support
- Safety Database Management
- Case Processing
- Safety Reporting (SUSARs)
- Medical Coding
