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GLOBAL CLINICAL TRIAL SERVICES

STRATEGIC CLINICAL RESEARCH DESIGNS
AND INTERPRETATION OF CLINICAL EVIDENCE

Product Development Plan
PMS Data
Protocol Design
PRODUCT KNOWLEDGE
Marketing Authorization
Conduct of Clinical Trials
Submissions
Reporting
Therapeutics
Diagnostics
Medical Devices
Pharmacovigilance
Portfolio Management 		 

SUCCESSFULLY TRANSFORMING DATA INTO KNOWLEDGE
ON A GLOBAL SCALE

PROJECT MANAGEMENT

Site identification/recruitment
 IEC/IRB coordination
 Regulatory authority submission
 Study protocol supply
 Monitoring
 Investigator meetings

DUE DILIGENCE

Assessment of development strategy
Assessment of compliance for products
Assessment of quality systems

MEDICAL WRITING

Protocol/ CRF design
Investigator's brochure
Integrated study reports
Manuals
Science review
Safety narratives

DATA MANAGEMENT / STATISTICS

Data management plan
 Database setup, maintenance and programming
AmedoneCRF/hybrid EDC solutions
Data validation
 Statistical analysis
Web portals
 Disease/product registries

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