Investigator-Initiated Trial (IIT) Support
Partner with Us to Advance your Psychedelic Research
We specialize in supporting Sponsor-Investigators who are pioneering therapeutic approaches with psychedelic treatments. Our team offers unparalleled expertise in navigating the complexities of clinical research and psychedelic treatment paradigms while ensuring the highest quality and integrity throughout your study.
Our project team ensures every aspect of your trial is optimized—from regulatory submissions to participant care. We collaborate closely with Sponsor-Investigators to develop tailored solutions that meet research goals while staying within budget.
How We Support IITs
Regulatory Expertise
- FDA, IRB, and DEA submission guidance
- Inspection readiness and quality assurance
Comprehensive Clinical Trial Support
- Clinical monitoring and operations support
- Data and document management (including eTMF)
- Project management tailored to your study's needs
Training & Therapeutic Modality Development
- Customized psychedelic treatment training for facilitators and staff
- Participant-centered approaches emphasizing safety and efficacy
Tailored Budget Solutions
- Flexible services to align with research budget constraints
- Assistance with budget development
- Hourly trust account agreements available
Specialized Offerings
- Facilitator/therapist manuals and role-specific training
- In-person trainings, which could include a breathwork experiential
- Room setup consultations for optimal session environments
- Music playlists and educational materials tailored to your study
Discover More With GuideSite
Let’s gently explore together how GuideSite Consulting can enrich your path. Book a chat to uncover the possibilities within our services.