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.
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).
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, TMF, trial master file
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.
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%.
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
If your company is preparing to launch a new drug or medical device, it’s important you have a team of experts supporting you every step of the way. Considering the high costs and amount of risk involved, outsourcing key, strategic components of the work to a Functional Service Provider (FSP) can free up time and help you better allocate resources.
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, clinical research jobs, clinical outsourcing, FDA inspections, biopharma, biomedical research, medical research, medical device manufacturer, food and drug administration
Many industries seek to standardize the data they collect, analyze, and make decisions upon. The pharmaceutical, biotechnology, and medical device industries are no different.
Topics: Data Management, biometrics, clinical trials, data governance, data operations, Smoot, global library
Is your current data management provider struggling? Perhaps they are under resourced, have antiquated SOPs, use cumbersome systems, or are simply not a good fit for your team and culture. All these items contribute to poor quality either overtly or more subtly by revealing themselves at, unfortunately, the wrong time.
Topics: Data Management, Quality Assurance, biometrics, clinical trials, rescue studies
Edit check programming and testing is time consuming and labor intensive. As such, it is efficient to minimize the time spent on programming by getting it right the first time. Historically, data management have measured edit check success as the percentage of edit checks that pass User Acceptance Testing (UAT). However, that may not be the best measure. What if an alternative metric leveraging Lean Six Sigma Methodology was used? The Rolled Throughput Yield (RTY) is a metric often employed in manufacturing operations to detect the probability that a process with more than one step will produce a defect free unit. If we track this metric for the edit check process, we can better gauge the probability of success of the edit check program.
Topics: clinical trial consulting, Data Management, Database Development, Clinical Research, Biotech
