CRO SERVICES
Clinical Trials
SRA offers a flexible and rapid approach to getting your product from development to market. Depending on your requirements, we can manage selected parts of the project or the entire effort from beginning to end. From protocol design to the submission of a study report, we can assist throughout the project’s lifecycle.
From individual Phase I studies to complete Phase IV programs, our global clinical teams coordinate single-center to multi-center trials around the world and across therapeutic areas. We also have experience with diverse niche studies, including:
- Volunteer studies in academic units
- Trials in African countries based at GCP-naïve sites
- Studies of pediatric populations
- Phase I studies of genetically modified products
Benefits
- Supplements staff knowledge with subject matter expertise where it’s most needed
- Aligns long-term program objectives
- Offers consistency throughout the project lifecycle
- Speeds regulatory approval
- Reduces time to market
Services
- Project management
- Clinical study monitoring
- Medical and safety monitoring
- Feasibility studies
- Phase I-IV program management
- Lifecycle support from protocol design to clinical study report
- Investigator recruitment and qualification
- Investigator meetings logistics and management
- Case Report Form development
- Clinical study tracking
- Investigator contracts and payments
Success Conducting a Phase III HIV Clinical Trial Began with Enrollment
SRA is conducting a Phase III multiple-center study on a delivery system for administering an HIV drug. Our services include comprehensive project management, clinical monitoring, and data management. The study involves 300 HIV-positive subjects at 60 sites located in the United States and Puerto Rico. When we initially began the project in 2005, the client, a U.S.-based pharmaceutical company, expected enrollment to occur over a seven-month period. SRA was able to successfully enroll all subjects within three months.