Clinical Solutions
We provide the following services for clinical Phase I, II, III, post market, and real-world research
1
Regulatory Affairs
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IND & NDA Submission
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CDE Communication Meeting Application
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Submission Dossier Preparing
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Gap Analysis
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DMF/CEP Registration
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Consulting Services
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QC Testing Arrangement
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Renew & Variation Application
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Regulatory Strategy Development
2
Medical Writing
Regulatory Writing
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Protocols and protocol amendments
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Informed Consent Forms/Patient Information Leaflets
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Clinical study reports
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Investigator Brochures
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Integrated summaries of safety/efficacy
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Literature summaries
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Clinical trial registry synopses
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Narratives
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Statistical Analysis
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Protocol design
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Sample size calculation
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Randomization (IVRS/IWRS)
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Statistical analysis plan (SAP)
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Statistical Programming (Double)
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Table Listings and Graphs
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Blinded Topline Tables
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Interim Analysis with Independent Data Monitoring Committee (IDMC) or DSMB
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Futility Analysis
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Bayesian Analysis
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Statistical analysis report (SAR)
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Clinical study report (CSR)
3
4
Clinical Monitoring
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Inspection and management
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Ensure projects comply with ICH-GCP and regulations
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Ensure the complete execution of the protocol
5
Site Management(SMO)
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Start-up
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Site management
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Quality & progress
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Site close-out
6
Data Management
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CRF-Design (e-CRF and paper-CRF)
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Electronic Data Capture (EDC)
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Data Management Planning
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Database Design
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Data Entry
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Medical Coding
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Data Validation and Query Management
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Database Lock and Audit
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Database Documentation and Release
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Database programming
7
Medical Writing
Scientific Manuscripts
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Manuscripts
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Critical Reviews
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Abstracts
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Posters
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Symposia publications
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Slide presentations