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services
Click the links below to view details of the services we offer
- Case Report Forms - Electronic Data Capture System
- Customized Database and Data Entry Screens
- Real Time Data Collection and Analysis
- Data Validity Checking, Absolute Values, Out-of-Range Flags
- Quality Assurance of Clinical Data
- Adverse Events Coding (MedDRA)
- Medication Coding (WHO)
- Statistical Analysis Plans
- Data Statistical Analysis (SAS, S-Plus)
- Clinical Study Final Reports (according to ICH)
- Clinical Informatics Systems
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- Strategic Planning - Comprehensive Clinical Investigational Plans
- Clinical Protocol Writing (phase 1, 2, 3, and 4)
- Informed Consent Forms
- Investigator Selection, Qualification, Training
- Recruitment Strategies
- Study Operations Manual
- Assisting in obtaining IRB Approval
- Initiation of Studies
- Enrollment and Randomization (24 hours-a-day, 7 days-a-week)
- Monitoring Studies
- Coordination of Drug Shipment
- GCP Compliance Audits
- GLP Audits of Clinical Laboratories
- Quality Assurance of Data/Sites/Laboratory Results
- Serious Adverse Events Reporting
- Investigators Contract Management
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- Developing Product Regulatory Strategies
- Convening Expert Panels
- Development of Non-clinical Studies Plans
- IND Preparation including Clinical Protocol, Investigator's Brochure, Chemistry Manufacturing and Controls, Pre-clinical Pharmacology and Toxicology, Previous Human Experience
- IND Annual Reports
- Biological License Application (BLA) Preparation and New Drug Application (NDA) Preparation
- Drug Master Files
- Pre-IND Meeting Packages
- FDA Presentation Preparation
- Meeting with the FDA to Discuss Non-clinical and Clinical Investigational Plans
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