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.
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:
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.
Clinical trials play a critical role in evaluating the effectiveness of medical, surgical, or behavioral interventions. They’re the go-to method when determining if a new vaccine, prescription medication, or medical device is safe and successful in its goals.
Many industries seek to standardize the data they collect, analyze, and make decisions upon. The pharmaceutical, biotechnology, and medical device industries are no different.
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.
Earned Value Management (EVM) techniques are commonly used as a disciplined process to track Key Performance Indicators (KPIs), Cost and Schedule. Typically for long duration projects which may span several major subprojects, these techniques can be extremely useful to gauge the team’s ability to adhere to a cost budget or a critical timeline for the project. A clinical study is a classic use case for applying EVM techniques as there are major subprojects within the project spanning different resource types. Additionally, the monetary value of clinical studies ranging from ~$5M in a phase 1 trial to exceeding $100M for a Phase 3 trial offer the opportunity to realize substantial financial savings through crisp execution using KPIs as benchmarks through the study.