- North America, South America
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- Human Medicines, Biopharmaceuticals, …
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- Clinical development and testing, clinical CRO, Consulting - strategy and development, …
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Our team of research professionals and consultants, as well as members of the Veritas IRB, can assist you with the development of innovative study designs and procedures by providing you with an initial ethics feasibility assessment. Feasibility assessments are very useful as they allow you to benefit from the insight of the IRB at the development stage of your study protocol. As a result of the feasibility assessment process you also obtain valuable information on how to develop a protocol in accordance with applicable research ethics requirements such as minimizing risks of harm and maximizing benefits, respecting research participants’ autonomy, and protecting their privacy and confidentiality.
Veritas IRB has conducted feasibility assessments involving, for example:
- Conduct of clinical trials in emerging countries
- Retrospective use of stored tissue samples
- Recruitment of employees for research purposes
- Innovative placebo-controlled trials
- Clinical trials involving alternative medicine procedures
Since drug research and development necessarily involves risk, this risk must be managed through careful planning, which necessitates the development of a Human Research Protection Program (HRPP). Development of an HRPP implies that the persons responsible for the conduct of a clinical trial:
- adopt principles and standards toward the protection of research participants;
- develop a structure by which employees, partners, and suppliers understand the set principles and standards, know their responsibilities, and are accountable for maintaining the pre-established standards;
- develop a process by which compliance with the requirements of the HRPP is enforced and enhanced.
Veritas IRB’s regulatory and quality assurance experts can assist you, and your organization, develop an effective HRPP.
Our HRPP development services include:
- Review and analysis of existing HRPP
- Needs assessment of internal organizational structure and activities for HRPP development
- Standard Operating Procedure (SOP) and policy drafting
- HRPP compliance mechanisms development
- On-site advice and training on HRPP development and quality assurance
- Assistance with submissions for accreditation to the Association for the Accreditation of Human Research Protection Programs (AAHRPP)
Auditing and Monitoring of IRBs
As risk management in research with humans relies significantly on the review and oversight of Institutional Review Boards (IRBs) or Research Ethics Boards (REBs), proper IRB/REB selection and monitoring should be an inherent component of any comprehensive quality assurance or quality improvement plan.
Auditing and monitoring of IRB/REBs is an extremely useful tool for the management of your trial. Indeed, it can allow you to:
- ensure appropriate research participant protection at your selected sites;
- select effective IRB/REBs in accordance to your needs and requirements;
- better understand IRB/REB’s processes and expectations;
- identify the IRB/REB’s processes for managing unanticipated events ;
- improve management of multi-center trials by identifying potential site-specific delays;
- prevent problematic inspections and costly shutdowns of your trials.
Veritas IRB’s quality assurance professionals will modulate their audit/monitoring strategy based on your needs whether it is to qualify potential IRB/REBs for an upcoming study, monitor compliance with applicable regulatory requirements or act upon suspected instances of non-compliance. Such a strategy may involve a documentary review, phone interviews, an on-site visit or a combination of the above.
With the increasing shortage of seasoned investigators, there have been tremendous efforts by the industry to recruit physicians into conducting clinical trials. Although they receive training on the conduct of clinical research in general, and more specifically on the conduct of the clinical studies in which they are participating, these new investigators may have had little or no exposure to research ethics or the ethics review and oversight process.
Veritas IRB has invested considerable effort to assist the industry in developing a new generation of seasoned investigators and promote ethical research through various initiatives such as Veritas IRB’s Investigator’s Manual. This manual is distributed to all clients of Veritas IRB and to all investigators whose sites ae reviewed by Veritas IRB’s board as a ready resource on how to conduct ethical clinical research.
Veritas IRB can further assist you in building knowledge and experience through educational site visits. The aim of these visits is to sensitize investigators and their research teams to research ethics principles, research participant protection, and the role of the IRB. Such initiation visits can also take place via teleconference, videoconference, or webinar depending on the technology accessible at the site.
Also, Veritas IRB may conduct, at the request of the Sponsor of the trial, a “for cause” visit to help a site improve its knowledge on research participant protection.
Introductory Training for Investigators
The investigator plays the most direct role in conducting and managing clinical trials. In order to ensure that clinical trials adhere to the relevant ethical guidelines, it is essential that the investigator understands his/her roles and responsibilities in conducting ethical research. The Introductory Training for Investigators is a one-day program focused on providing a robust survey of the theoretical and practical considerations an investigator must take in order to adhere to ethical guidelines governing each step of the clinical trial process.
The training consists of four modules:
- Evolution of Research Ethics
- Philosophical Theories and Principles in Research Ethics
- Roles and Responsibilities of the Research Team
- Essential Documents for Clinical Trials
A comprehensive understanding of the principles behind research ethics allows researchers and their staff to understand the importance of a research team’s conduct in protecting the rights and well-being of research participants. Introductory Training for Investigators aims to impart this theoretical knowledge in combination with a thorough familiarity with ethical guideline documents and a practical understanding of the necessary managerial tasks. This comprehensive training program will ensure that investigators have a rigorous understanding of their roles and responsibilities in the conduct of ethical research at every step of the clinical trial process.
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