Supporting Investigator Initiated Trials
Investigator-initiated Trials (IITs) are conducted under the full responsibility of a third-party such as an academic institution, research universities, hospitals, or by individual qualified investigators with or without the assistance of a pharmaceutical sponsor.
Carefully planned and executed IIT strategies provide quick proof-of-concept data and accelerate drug and device development. IITs provide expanded product knowledge regarding safety and efficacy. New ways of using approved therapeutic products are often identified by physicians, resulting in improved treatment outcomes for patients.
With over 15+ years experience, our CRO team can provide end-to-end support for Principal Investigators and other independent research organizations to successfully conduct clinical trials and generate scientific evidence.
How We Can Help
- Assist investigators with developing a study protocol that meets regulatory requirements and adheres to best practices in clinical research.
- Obtain regulatory approvals and submitting the necessary documents to regulatory agencies.
- Provide training to investigators and site staff on GCP, study procedures, and regulatory requirements.
- Serve as a liasion between the sponsor and the independent research team to manage trial supplies and investigational product.
- Provide cost-effective EDC, RTSM, CTMS and other clinical technology to faciltiate study data collection, clinical trial management, etc.
- Perform statistical analysis and generate reports on study results, which can help investigators to draw meaningful conclusions and prepare publications.
