 |
 |
 |
 |
 |
 |
||||||||||||||||||||||||||||||||
|
Category |
Design |
Purpose |
Timing |
|
Global Clinical Trials |
II-IV |
Registration or Label Enhancement |
Pre-registration or |
|
Outcomes Research |
Disease Registry |
Unmet needs assessment, |
Throughout clinical development & |
|
Drug Registry |
Clinical effectiveness assessment |
Post-registration & | |
|
Safety Surveillance Study |
Risk assessment |
Pre- and Post- registration & | |
|
Epidemiological Study |
Incidence and prevalence assessment |
Throughout clinical development & | |
| Cost effectiveness study | Assess cost effectiveness, cost saving, burden of illness, and utility | ||
|
Syndicated Study |
Syndicated Study |
Trends and opportunity assessment |
Lifecycle management |
|
Data Mining |
Hospital or office |
Retrospective analysis of |
Pre-registration and |
Clinical Operation Support:
· Design
o Develop study protocol
o Develop Case Report Forms
o Develop patient consent form
o Develop investigator study binder
o Develop electronic data capture system
· Study Execution and Project Management
o Perform site feasibility assessment
o Coordinate institution research board approval
o Develop and conduct site training
o Organize and conduct investigator meetings
o Monitoring patient enrollment and data reporting
o Adverse event monitoring and pharmacovigilance management
o Verify source documentation and collect study materials at study closing
o Budget management
o Communication and overall project management
· Medical Writing
o Prepare for safety & efficacy summaries (ISS/ISE)
o Prepare for clinical study reports
o Assist for regulatory submissions and annual reports
o Prepare for abstracts, presentations, posters, and manuscripts
o Prepare for patient and physician education materials
Data Management and Bio-statistics Support
Data management and bio-statistics support is provided by our "Clinical Data Center". We develop state-of-the-art software to efficiently EDC (electronic data capture) system.
· Data Management
-
Data management plan and validation conventions
-
CRF annotation and data transfer schema
-
Database design, construction, and qualification
-
CRF logging, tracking, and pre-entry review
-
Double data entry and verification
-
Data field and cross-form edit checking
-
Secondary data review and quality assurance
-
Automated and manual query management
-
Preferred term encoding (MedDRA, WHOdrug)
-
SAE reconciliation
-
Database freeze, lock and audit
· Bio-statistics
-
Sample size and power for parallel, crossover and replicated designs
-
Statistical Analysis Plan preparation
-
Subject randomization using central and stratified adaptive methods
-
Statistic programming, analysis & validation
-
Comprehensive ICH summary tables, figures, and listings generation
-
Meta analysis and mixed-effects modeling
-
Interim analysis and reporting
-
Exploratory analysis, ad hoc and custom data summaries
