Envision Research manages clinical trials and connects physicians with leading pharmaceutical and medical device sponsors and Contract Research Organizations (CRO
What Envision Research can provide to your site:
- Connect your practice with leading pharmaceutical, and medical device sponsors and Contract Research Organizations (CRO)
- Feasibility assessment
- Contracting and budgeting
- Regulatory and Institutional Review Board (IRB) management
- Study-specific site training
- Infrastructure and resources needed to conduct clinical trials, including support by experienced clinical research coordinators
- Standard Operating Procedures (SOP) for quality assurance
- Patient recruitment strategy
- Data management
- Clinical Trials Management System (CTMS)
- Adherence to Good Clinical Practice (GCP) and quality control
- Timely and successful completion of clinical trials
Contact us if you are interested in starting a new clinical trial.
Why Clinical Trials are important
A clinical trial is a research study that involves human volunteers to test the safety and eﬃcacy of new medical products (e.g. drugs or devices) or new ways to use existing medical products for
- Patients have access to cutting-edge prospective treatments, individualized medical care, and receive study-related medical care at no charge
- Participating physicians are kept up to date on novel therapies
- Clinical trials increase clinic revenue
Principal Investigator Responsibilities
- Identify qualiﬁed candidates for study participation
- Supervise the research team
- Secure informed consent from study participants
- Ensure investigational drug/device management
- Assure patient safety and patient rights
- Receive IRB approval
- Conduct the trials according to protocol and Good Clinical Practice (GCP)
What does it take to conduct a clinical trial?
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.
QUALITY ASSURANCE AND CONTROL
Develop Standard Operating Procedures (SOP) for quality assurance and monitoring of studies for quality control.
A Local or Central Institutional Review Board (IRB) can be contracted to review the study protocols. Regulatory ﬁles and documentation for the study should be maintained for the period of time speciﬁed in the study protocol or contract.
The Principal Investigator (PI) is ultimately responsible for the conduct of the clinical trial. Sponsors look for sites with knowledgeable PIs, trained staﬀ, and appropriate resources for successful conduct of clinical trials. The minimum required staﬀ includes the PI and a research nurse or a Clinical Research Coordinator (CRC).
OTHER RESOURCES THAT MAY BE NEEDED
- Legal counsel
- Contract specialists
- All study-related information must be maintained in a secured area to protect patient privacy.
The site should be able to demonstrate to the sponsor that it has the appropriate patient population for the clinical study.
Frequently Asked Questions
Who can become a clinical trial investigator?
- 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.
Why should I consider becoming a clinical trial investigator?
- Clinical Trials investigators play an important role in the development of drugs, therapies and medical devices to combat disease, treat chronic and degenerative diseases, and improve the health of people throughout the world. By conducting clinical trials, you:
- Remain at the cutting edge of your specific area of therapeutic interest
- Offer your patients new treatments that may only be available through participation in clinical trials
- Open opportunities for additional revenue to your practice
- Support innovation in medicine
What are the general responsibilities of a clinical trial investigator?
An investigator is responsible for:
- Protecting the rights, safety
andwelfare of study participants
- Obtaining the informed consent of each study participant
- Controlling the investigational products under study
An investigator ensures that a study is conducted per the:
- Signed investigator statement
- Investigational plan
- Applicable regulations
Who are my partners in clinical trials?
- Envision Research provides the infrastructure to identify and secure clinical trials and initiate and support all aspects of clinical trial execution in collaboration with community physicians and investigators at their practice.
- Sponsor – Pharmaceutical, biotechnology, and medical device companies, government agencies, and individual researchers.
- CRO – Contract Research Organizations provide support services for sponsors in the conduct of their clinical trials. CROs are contracted to manage clinical trials from study initiation to final regulatory approval of the test article.
- OHRP – The Office for Human Research Protections provides ethical oversight, support, and clarification of federal regulations to institutions and investigators conducting research with human participants.
- Vendors – Ancillary services designated by the sponsor or CRO for the clinical trials, such as data management, laboratory, and patient recruitment and retention services.
- IRB – Institutional Review Boards review clinical research studies to ensure the welfare and protect the rights of study participants under federal regulations.