Become A Site
Envision Research offers comprehensive services for identifying, securing and managing industry-sponsored and publicly funded clinical trials.
Envision Research can help your institution or practice become a clinical trials site.
Resources you will need:
The Principal investigator (PI) on a clinical trial. Clinical trial investigators should hold a doctoral-level degree (PhD, PharmD, DNP, DO, MD, DDS or equivalent degree) and work in private practice, medical schools, or teaching hospitals.
Sponsors look for sites with knowledgeable PIs, trained staff, and appropriate resources for successful execution of clinical trials. The minimum required staff in addition to the PI is a research nurse or a clinical research coordinator (CRC). Envision Research can provide this for you.
Training and Education
All study staff, including PIs, should be trained in Good Clinical Practice on an ongoing basis. Understanding regulatory requirements is essential for compliance and for protection of human subjects. Human subject protection and HIPAA training for clinical trials is very important. Envision Research can provide this for you.
Local or an AHRPP accredited Central Institutional Review Board (IRB) can be contracted to review the study protocols.
Regulatory files and documentation for the study should be maintained separately and for periods specified in the study protocol or contract. Envision Research can connect you with an accredited IRB.
If clinical trial involves investigational drugs, pharmacy for preparing and storing study’s investigational drugs is a good resource to have. Trained staff to handle drugs in adherence to the study protocol is a minimum requirement.
Legal counsel or contract specialists may be required for review of contracts with clinical trial sponsors. Envision Research can guide or provide this for you.
Space and Equipment
All study related information must be maintained in a secure area to protect patient privacy.
Available space for staff to conduct the clinical trial, short and long-term storage of research charts and regulatory documents and for study sponsor monitors to visit and review research data. Dedicated phone line, fax line, copy machine, and computer with high-speed internet service.
The site should be able to demonstrate to the sponsor that it has the appropriate patient population for the clinical study. Keeping a record of billing codes, patient registry, log of diagnoses and stage of patients seen, including new patients and patients who return for a period of time, are essential elements for patient recruitment and enrollment to a study.
Each study should be reviewed against scientific merit, available patient population and resources, study revenue and costs, and time and effort required for patient recruitment and conduct of the study. Envision Research can guide you in this process.
Develop internal procedures to identify responsibilities and steps for study implementation, management, and quality assurance. Envision Research can assist you with this.
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