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
