We provide assistance in moving clinical trials through the start-up process, including OCT, IRB, OSR and CRMS.
Regulatory consultations are available to guide and support you as you design protocols, navigate through the approval process and conduct your research.
We provide expertise and guidance on completion of a variety research forms and regulatory documents required when implementing a clinical study. Services include:
- IRB Application preparation, review or guidance
- Guidance responding to IRB contingencies
- Consent form preparation or review
- Consent process guidance
- Regulatory document guidance
- Guidance with study start-up and implementation
Links and guidance documents to help in developing a research protocol:
- CTTI Recommendations: Quality by Design
- CTTI Principles of a Quality Protocol Document
- Clinical Trials Protocol Template – draft guidance from NIH & FDA
- Clinical Trials Protocol Template - shell
- CTTI Recommendations: Efficient and Effective Clinical Trial Recruitment Planning
- Learn about the CTTI Quality by Design project at www.ctti-clinicaltrials.org