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CLIENT INFORMATION
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SERVICES OF INTEREST
Preparation
IND/IDE
Investigator's Brochure
Protocol/Amendments
Informed Consent Form
Case Report Forms (CRFs)
Study Documentation (Logs, Manuals, Worksheets)
Clinical Site Management and Monitoring
Selection of Sites/Investigators
Investigator Meeting (Planning, Materials Preparation, Coordination)
Site Qualification
Site Initiation
Site Management
Clinical Site Monitoring
Supply Management (Test Article, Clinical Supplies)
Laboratory Selection/Qualification
Randomization
Regulatory Affairs
Regulatory Activities
GCP Quality Assurance Audits
GCP Training
DSMB Management
Informed Consent Form Translations
AE/SAE Reporting/Management
Protocol Registration
IND Reports (Quarterly, Annual, Safety)
Project Management
SOP Development
Site Support
Protocol Help Line
Maintenance of Trial Master File
Data Management
Database Development
Data Entry and Management
Patient Validation (Verification of Eligibility)
Data Transfers
Medical Coding (MedDRA, WHO-DD)
Data Quality Assurance Audits
Biostatistics
SAS Programming and Data Sets
Statistical Analysis Plans
Medical Writing
Clinical Protocols
Clinical Study Reports
Interactive Voice Response System (IVRS)
Patient Enrollment
Drug Supply
Patient Diaries
Clinical Supplies