Phase I study is the first step for new drug's studies in human body, the safety and dosage for clinical therapeutic needs to be clarified, including metabolism, distribution velocity and extent. The special population, food effects and drug-drug interactions will be clear understanding during the study process.

 
Quality and Science driven that earns client's trust.

We take a scientific approach from protocol development to clinical report, and give attention to every project.


Regulatory Affairs
> Clinical Trial Application (CTA)
> IEC Submission/Approval
> Communication with regulators
> Drug Import Application
> Regulatory Consulting

Bioanalytical Services
> Method Development
> Method Validation
> Bioanalysis
> Bioanalytical Report
> GLP Compliance

Project Management
> Clinical site Identification
> Staff Training
> Randomization
> Meeting Management
> Sponsor, IEC Correspondence
> Document Management
> Material Management
> Quality Assurance
> GCP Compliance

Pharmacokinetic and
Biostatistical Analysis
> Phamacokinetic analysis
> Data interpretation
> Sample Size Estimation
> Randomization Scheme
> Statistical Programming
> Statistical analysis
> Statistical Report

Site Management
> Site Contract
> Investigator Contract
> Site Initiation
> Study Monitoring
> SAE/AE Reporting
> Study Close-out

Medical Writing
> Clinical Study Protocol
> ICF/Information Leaflet
> Investigator Brochure
> Medical Translation
> Regulatory Submission
> Clinical Study Report (CSR)

Data Management
> CRF Development
> CRF/DCF Tracking
> Database Set-up
> Data Entry
> Data QC
> Medical Coding
> Database Lock/Release

Financial Management
> Site Budget and Contract
> Investigator Payments
> Pass-Through Accounts
> Subject Insurance
> Subject Compensation