In 2017, Congress passed bipartisan legislation requiring the Food and Drug Administration (FDA) to develop a grouping of over-the-counter hearing aids. Though passed more than five years ago, the law is only being implemented now.
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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, biostatistics, biometrics, FSP, clinical trials, online meetings, project management, Good Clinical Practice, healthy living, patient enrollment, FDA inspections, medical research, food and drug administration, medical patients
Up to 5 million Americans have left their jobs during the ‘Great Resignation’ and that number’s still growing. While numerous industries are experiencing record turnover, it’s especially acute in healthcare. According to one report, 20% of medical professionals have left the field, including clinical trial assistants, clinical research associates, and study monitors.
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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, inspection readiness, Data Management, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, Quality Assurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, data operations, Good Clinical Practice, patient enrollment, patient recruitment, clinical research jobs, clinical outsourcing, FDA inspections, biopharma, biomedical research, medical research, medical device manufacturer, food and drug administration, patients, medical patients, budget, clinical research data management, great resignation, staff shortage, quality data
The Trial Master File (TMF) is one of the most important systems in clinical research. It plays a pivotal role in demonstrating your assertion that your clinical study was conducted in adherence to the protocol using the principles of Good Clinical Practice (GCP).
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Designing and implementing clinical trials isn’t cheap. One report submitted to the U.S. Department of Health and Human Services (HHS) found that the average cost of a Phase 1 trial was $4 million, while the average cost of a Phase 3 trial was $20 million. Considering that up to 85% of all trials experience delays, your budget can quickly balloon out of control.
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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, inspection readiness, Data Management, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, Quality Assurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, patient enrollment, patient recruitment, clinical research jobs, clinical outsourcing, FDA inspections, biopharma, biomedical research, medical research, medical device manufacturer, food and drug administration, patients, medical patients, budget
Low patient retention is one of the greatest challenges that clinical researchers face. One study, conducted by the Tufts Center for the Study of Drug Development, found that between 2012 and 2019, patient dropout rates increased from 15.3% to 19.1%.
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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, inspection readiness, Data Management, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, Quality Assurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, patient enrollment, patient recruitment, clinical research jobs, clinical outsourcing, FDA inspections, biopharma, biomedical research, medical research, medical device manufacturer, food and drug administration, patients, medical patients
It’s hard to believe, but 2021 is coming to a close. After almost two full years of pandemic-related changes, many industries have had to adapt and evolve just to stay afloat.
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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, data mangement, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, new years, patient enrollment, FDA inspections
Bringing a new drug, therapy, or medical device to market is a time-consuming and cost-intensive process. In fact, the average clinical trial takes six or seven years to complete with a typical price tag of $2.6 billion.
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The last year and a half have been a whirlwind, particularly for clinical researchers. While the trial landscape is ever-evolving, efforts to “slow the spread” of COVID-19 have accelerated the process.
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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, Clinical Research, Biotech, Pharmaceuticals, biotechnology, biostatistics, biometrics, FSP, clinical trials, online meetings, project management, Good Clinical Practice, patient enrollment, FDA inspections
Designing and implementing a clinical trial is a time-consuming and costly process. In fact, a 2014 report by Aylin Sertkaya et al. submitted to the U.S. The Department of Health and Human Services found that on average:
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Topics: clinical trial strategic planning, clinical trial consulting, clinical trial remote services, Clinical Research, Pharmaceuticals, clinical trials, patient enrollment, patient recruitment
Clinical trials play a critical role in identifying and developing new treatments. They advance medical research, allow for improved patient outcomes, and enhance our knowledge of human biology. Unfortunately, they aren’t always easy to recruit for. In fact, approximately 85% of clinical trials fail to enlist enough participants to move forward.
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Topics: clinical trials, patient enrollment, patient recruitment, study start up
