5 Things a Landlord Should Know About Recreational Cannabis in Illinois

KOVITZ SHIFRIN NESBIT | November 21, 2019

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Registered qualifying patients under the Compassionate Use of Medical Cannabis Pilot Program Act, are granted certain exceptions for possession volume and cultivation of cannabis. Further, the CRTA does not permit any person to smoke cannabis in any place where smoking is already prohibited under the Smoke Free Illinois Act, such as restaurants, retail stores, offices, etc.

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QRC Consultants Ltd is a team of experienced QA, regulatory and clinical research professionals, dedicated to providing high quality, practical, responsive and cost effective services to support pharmaceutical companies primarily with early clinical development.

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New Dimensions of Clinical Trial Optimization

Article | April 20, 2021

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization. The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options? For many sponsors, the reason this process does not occur as often as it should, is because the nuanced statistical parameters of a clinical trial design are very difficult to communicate to non-statisticians. Yet a trial optimization tool like Solara, equipped with data visualizations and the ability to see tradeoffs intuitively, can overcome this challenge. The real challenge is often convincing the non-statistician that they have a stake in clinical trial design. Cytel recently had a client that thought it needed a sample size re-estimation design, because it had a very strict limit on the number of patients it could enroll. After a few hours of working with Solara, though, a statistician discovered that a much simpler Group Sequential Design would deliver comparable power using about the same number of patients. The gains from the more complex design were minimal from the optimization perspective, when understood as the eco-system of choices. Similarly, most commercial teams pressure their clinical trial designers to have the most accelerated clinical trial imaginable, but as we all know, the longer the clinical trial the more likely there will be a higher number of events that demonstrate the effectiveness of a new medicine. So commercialization teams have a stake in longer clinical trials, even when their rule of thumb is to shorten them. Therefore, it is absolutely essential to communicate the benefits of various statistical designs to multiple stakeholders in a way that makes tradeoffs clear. Aligning on priorities early during the clinical trial design process is essential to selecting the optimal clinical trial. Yet for this statisticians need to be equipped for both a strategic and communicative role in the R&D process.

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Clinical Development Risks and Issues in a COVID-19 World

Article | March 20, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).

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5 Pharma Trends and Their Impact on Packaging

Article | February 27, 2020

The pharmaceutical industry is changing at an unprecedented pace. New biological treatments for cancer, and a dramatic rise of widespread diseases such as diabetes, call for new processing and packaging solutions to fulfill the different needs all over the world. Keep your eye on these five main packaging trends for 2020 for the global pharmaceutical market.

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How Can Medical Cannabis Help to Manage Pain Conditions? – The Cannabis Exchange

Article | February 11, 2020

Pain management is one of the most common reasons for the use of medical cannabis products. However, despite many jurisdictions – including Canada, Germany, and the Netherlands – now allowing the prescription of medical cannabis for this purpose, there remains little ‘high-quality’ evidence to support, or oppose its efficacy. Madden et al. (2018) set out to review the evidence available in order to determine the efficacy of medical cannabis when employed in the management of various forms of musculoskeletal pain. The researchers analysed various studies that assessed the use of cannabinoids in the treatment of arthritis pain; back pain; postoperative pain; and trauma-related pain. It is estimated that up to 30% of the population may suffer from a non-cancer-related pain condition. As such a high percentage of people suffer from these conditions, the development of simple and safe therapies is an essential area of research. This is particularly important as the therapeutic options for people with chronic pain are increasingly limited.

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QRC Consultants Ltd

QRC Consultants Ltd is a team of experienced QA, regulatory and clinical research professionals, dedicated to providing high quality, practical, responsive and cost effective services to support pharmaceutical companies primarily with early clinical development.

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