Clinical Trial Expertise
Our Clinical Trial Expertise Includes the Following Services:
- Full Phase IIIb & IV Study Capabilities
- Regulatory Submissions
- Study Design and development and print management
- In-house ethics preparation and submissions
- Site/subject recruitment and support
- Site coordination/management and monitoring
- Data management and analyses and reporting: Real time data quality control, data verification, extraction and analysis
- Production/Fulfilments
- QA
- Honoraria management
- On line reporting/automated reports to monitor study progress
- QA/Safety Surveillance: Full AE/SAE management, including data collection, reporting, coding, follow up
- Poster Development and Presentations
- Medical Inventory Management
o Design and development of Safety and Risk Management Programs
o Publications
o Patient Registries
o Quality of Life Studies
o Chart Audits
o Experience trials
o Expanded Access Programs/Special Access Programs
o Transitioning of Clinical Trial Patients