Specialty | Quorum Review IRB
Quorum recognizes the unique needs associated with large clinical trials: high-volume site reviews, milestone achievements, priority sites, fast turnaround, steady communication with the IRB, and more. Quorum provides the advantage in large studies with twenty-five years of experience in reviewing and overseeing research. Our AAHRPP-accredited ethics boards and expedited reviewers have the capacity to manage studies of any size, while our customer-centric approach with a single point of contact and user-oriented electronic tools, ensures everything runs smoothly.
For large studies, Quorum provides a package of useful services and resources. Our early engagement services, which combine personalized service, submission assistance, and comprehensive reporting, can help your large, high-priority study reach every milestone.
Research In Canada
Studies that cross international borders can produce broad scientific insights, but different regulations for different authorities complicate study management. Quorum understands these difficulties, and we offer reviews that can bridge countries. Our North American Board’s reviews cover Canadian and U.S. research. Quorum operates fully within Canada’s Tri-Council Policy Statement for Research Involving Humans (TCPS), we appreciate the differences between provinces, and our British Columbia-based IRB/REB operates with the same user-oriented processes and technologies as our Seattle and Cambridge boards.
International research can provide crucial scientific insights, but myriad ethical review standards complicate any human experiments overseas. Quorum has experience reviewing international studies and can support it in one of three ways:
- Review for compliance under the Good Clinical Practices of the ICH (i.e., International Council of Harmonisation of Technical Requirements for Pharmaceuticals for Human Research), local standards, and U.S. standards (if applicable);
- Collaborate with local ethical review committees ; or
- Serve as the sole IRB of record where no local review committees exist.
Quorum can translate consent forms and other study documents into the appropriate languages. Quorum is also available to provide consulting services to help you prepare for your research abroad and assess local regulatory requirements.
Adaptive Trial Design
Adaptive Trials present unique challenges for investigators and regulators alike. Adaptive trial design accommodates rapid adjustments to events in the study, but understanding the overall design and applying incremental changes can complicate an IRB’s oversight.
With researchers pursuing the flexibility of stopping dosing arms, changing randomization proportions, or combining multiple phases into a single trial, finding an IRB with the proper knowledge and understanding is crucial. Quorum has the right experience to oversee a study with an adaptive trial design. We have:
- A history of reviewing adaptive designs in pharmaceutical, biological, and device trials.
- A wide diversity of Board therapeutic experience
- Familiarity with all phases of pharmaceutical research
- An enhanced review approach: Quorum maintains a consulting relationship with an external biostatistics group to help verify the statistical integrity of your study.
Public funds account for an important segment of research in Canada and in the United States, and lead to crucial discoveries. Quorum pivots smoothly between private and public funding; we apply the same processes and resources to each. Our AAHRPP-compliant boards comply with the United States’ Common Rule and Canada’s Tri-Council Policy Statement. We can oversee federally funded studies as a local IRB/REB for one investigator or as a central IRB/REB for multiple-site studies. We include grant reviews in each submission to the IRB.
Human Gene Transfer
Advancements in biotechnology and genetic engineering exponentially increase interest in using gene therapy technologies in research studies. Gene therapy studies are a relatively new frontier and present unique challenges for maintaining safety standards in research. At Quorum, the IBC maintains safe procedures and conduct for study staff, provides guidelines for containment of genetically modified agents to designated research space, and prevents community and public exposure to biohazardous waste. When you partner with Quorum for IBC services, you can expect a quality and detailed review to ensure your study is NIH and CDC compliant and a safe environment to conduct research. Quorum offers the only coordinated IRB and IBC review that provides seamless integration of human subject protection and biosafety to ensure efficient study startup and a superior client experience.
As important as it is to find better treatments for children, or to confirm that a product for adults also works for children, researchers must take special considerations when evaluating the risks and benefits of a pediatric study. Protocols for this vulnerable population require extensive safeguards, and researchers must approach the consent of the parents as well as the assent of the minor with care.
Quorum has over two decades of experience with pediatric trials. We have pediatricians as board members and as consultants. We can engage pediatric researchers early, and ensure they are equipped to conduct a pediatric protocol, administer consent and assent forms, and protect young study participants. Our AAHRPP-accredited boards, electronic tools, and knowledgeable staff provide the advantages that these studies deserve.
The study of biologics – medical treatments manufactured from living cells — represents one of the most exciting areas of clinical research today. When a study has to start or change quickly, our process-engineered tools can help. Our experienced board members, service-oriented staff, and knowledgeable regulatory teams appreciate the unique needs of biologic research. With biologics on the cutting edge of medical research, Quorum’s tools and experience provide the advantages you need.
Biologics - Vaccines
Vaccine trials can be large, and they often need to be fast. Quorum has a long history of reviewing vaccine trials; in 2010 the National Institutes of Health recognized our contribution to the H1N1 flu virus trials.
From our experience with vaccine trials, we know how to support them: rapid delivery of approval documents, daily review of every type of submission, and an international reach.
Minimal Risk Studies and Expedited Review
Not every study protocol needs to be reviewed by a fully-convened IRB board. Quorum has fully compliant, AAHRPP-accredited criteria for appropriately referring research to expedited reviewers instead of a board meeting. Qualifying minimal risk studies — such as retrospective chart reviews or some Phase IV observational studies — have review and approval timelines that are substantially faster than other reviews. We can respond to qualifying submissions as soon as the next business day.
Retrospective Chart Review
By examining and assessing existing medical data, retrospective chart reviews (RCR) can reveal unexpected insights. But this type of research requires an understanding of the regulations around accessing medical information and – if applicable – the careful review by a proven IRB. With a wealth of research industry experience, Quorum offers a customized approach to handling the ethical and regulatory implications of these studies. For retrospective chart reviews we offer:
- Separate pricing
- Consideration of a HIPAA waiver
- Streamlined submission forms
- An industry-recognized regulatory team to provide expert consultation on the intersection of chart reviews, human subject research, and HIPAA privacy requirements.
Central Nervous System
Some of today’s most exciting medical research focuses on the central nervous system. CNS studies present unique challenges, with issues such as difficult recruitment, subject competency, and the complex role of legally authorized representatives (LARs). Quorum’s boards have experience with studies involving a wide range of psychological and neurological disorders, such as depression, pain, Alzheimer’s disease, Parkinson’s disease, anxiety, and schizophrenia. With Quorum’s single point of contact approach, our staff can help plan and manage these important studies.
Oncology is a complex, fast-moving and innovative area of clinical research. Cancer-related trials have risk-benefit ratios best assessed by a board with extensive experience and training. Plus, effective risk assessment and integrated safety management strategies require a cross-functional collaboration. Quorum’s unique oncology-focused ethics board in Cambridge offers expertise in oncology research and treatment. Whether your innovation involves a drug or biologic, a device, or a combination, we know how to structure our review.
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Contact us to learn about our therapeutic expertise or to obtain a board roster, a meeting schedule, or ethics review pricing.Contact Us