Phase I studies are largely nontherapeutic explorations of possible new drugs. As described by the FDA, Phase I studies aim to determine the metabolism and pharmacologic actions of a drug in humans; any side effects associated with increasing doses; and, if possible, early evidence of effectiveness. The studies often are “first-in-human”, that is, the first time anyone has received the drug. While some Phase I studies (notably oncology trials) recruit affected patients, most require healthy volunteers.
Quorum has developed a unique set of services to support Phase I trials. With the timelines in Phase I/Healthy, a study can start within days of an initial IRB application. We offer Phase I-specific processes (and timelines) for reviewing consent forms, recruitment materials, protocol amendments, and more.
Phase II trials follow a successful Phase I. In Phase II, researchers administer the drug to volunteers who have the disease or condition which the drug aims to treat, but these studies typically are not large enough to show whether the drug will be beneficial. Instead, Phase II studies provide additional safety data, and researchers can use the results to refine research questions, develop research methods, and design Phase III protocols.
Quorum’s Board members and staff are familiar with the range of Phase II studies. Our regulatory team can provide assistance in preparing these medium-sized, fast-paced studies for submission, and our operations teams provide guidance in the management and oversight of the ethics review process.
Under the U.S. FDA’s regulations for investigational new drugs (IND), Phase III tests the effectiveness of a new, experimental treatment. After Phases I and II gauge safety and dosages, Phase III assesses whether a product works. Phase III studies can involve 300 to 3,000 participants across numerous research sites and often have design complexities beyond their Phase I and Phase II predecessors.
Quorum excels in the management and oversight of Phase III studies. Our early engagement services reduce the time needed to design, organize, and launch a study. Our online tools such as the OnQ Portal make working with us easy. Our fast timelines for review and document delivery keep you on schedule, and our knowledgeable staff is there to help when you need it.
Also known as post-marketing or surveillance studies, Phase IV research gathers additional information about a drug’s long-term effects. The FDA can require Phase IV studies as part of its approval to monitor for any rare or long-term adverse effects in a much larger patient population.
Quorum supports a wide variety of Phase IV trials, including registries, observational studies and online research. Phase IV studies frequently are minimal-risk without interventions and can qualify for expedited review. Consider Quorum’s Expeditable Research Review services for your late-stage, low-risk study.
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