CLINICAL OPERATION CENTER

business_workingWe partner with global medical corporations to design and plan phase II-IV clinical studies and outcomes research, investigating unmet medical needs of specific diseases, clinical effectiveness of specific therapeutics, and opportunities to enhance scientific, economic, and market values of medical innovations;

We collaborate with health care organizations to conduct population based studies, investigating disease incidence and prevalence, trend and opportunities to improve disease management, and gaps between real life medical practice and evidence based medical guidelines.

 

Table below lists types of clinical trials we support:

 Category

 Design

 Purpose

 Timing

 Global Clinical Trials

 II-IV

Registration or Label Enhancement

Pre-registration or
Post-registration

Outcomes Research

 

Disease Registry

Unmet needs assessment,
Disease management assessment
Trends and opportunity assessment

Throughout clinical development &
lifecycle management

Drug Registry

Clinical effectiveness assessment
Pharmacoeconomic assessment
Unmet needs assessment

Post-registration &
lifecycle management

Safety Surveillance Study

Risk assessment

Pre- and Post- registration &
lifecycle management

Epidemiological Study

Incidence and prevalence assessment
Trends and opportunity assessment
Gap analysis
 

Throughout clinical development &
lifecycle management

 Syndicated Study

 Syndicated Study

Trends and opportunity assessment

Lifecycle management

 Data Mining

 Hospital or office
 based database

Retrospective analysis of
Incidence and prevalence
Trends and opportunities
Safety and risk
Cost effectiveness

Pre-registration and
lifecycle management

 
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 Biostatistics Support

Data management and biostatistics 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 mangement 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

·         Biostatistics

  • 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

 

 
 
 
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