For an investigational trial, clinical site documentation encompasses many types of records. These cover every aspect of patient care, policy guidance, and study execution. Not only does the patient medical history and care need to be maintained, but documentation supporting the plan and evidence of execution of a clinical trial must also be managed. This extensive collection of information is always subject to regulatory inspection.
Excitement around the potential for blockchain platforms continues to build. This parallels the surge in popularity of blockchain-based cryptocurrencies such as Bitcoin. Meanwhile, “critics argue it’s all hype — a technological hammer looking for a nail — and that the complexities of health information prevent practical use of blockchain technology.”
Patients, family members, and friends make up the largest user group of clinical trial registries such as ClinicalTrials.gov, according to the U.S. National Library of Medicine. Clinical trial registries serve many important purposes for patients, which is why having an online resource that is not only user-friendly, but also patient-centered, is imperative. Access to a wealth of information on clinical research has become increasingly important for many stakeholders, with patients at the forefront.
How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself?
Are you a clinical site that finds budget negotiations with a clinical research organization (CRO) or sponsor an uphill battle?
When a pharma or biotech sponsor company engages with a contract research organization (CRO) and other service providers, it develops a list that details which organization is responsible for each task to be conducted. The degree to which a small to midsize sponsor has the expertise and the resources internally to manage a task, as well as budgetary constraints, will dictate which tasks it delegates and which it keeps in-house.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Since my first Amazon article, readers contacted me about Amazon-like transformations in clinical research. I never expected clinical research trends to emulate Amazon’s playbook.
Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory providing clinical diagnostic testing services. As if that multimillion-dollar fine was not ominous enough, the DOJ announced another settlement in the same press release: It had imposed a $270,000 fine against the CEO of a related pharmacogenetics testing facility. The alleged wrongdoing centered on “sham” clinical trials, purportedly designed to mask improper payments to physicians who ordered pharmacogenetics tests.
In his recent column, Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP), challenged the industry to address the need to raise the standards of professionalism of the clinical research workforce.
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