Disparities related to diversity, equity, and inclusion (DEI) are common and well-known in clinical trials. It is well-documented that racial minorities, underprivileged, and non-white ethnic groups are much less represented in clinical trials. Historically, the numbers […]
Dealing with challenges in quality evidence generation with a real-time analytical framework that makes clinical sense for innovators
Evidence linking interventions with health outcomes is vital for healthcare decision-making. Making sound choices about healthcare requires the best possible and quality evidence from clinical research. However, some of the decisions currently made during the drug […]
Addressing challenges in patient recruitment and retention in clinical trials for accelerated regulatory approvals and patient outcomes
Even though the COVID-19 pandemic raised global awareness of clinical trials, most adults have never seen an advertisement recruiting volunteers to participate. In the U.S., half of the adult population is unaware of the clinical trial […]
By: Harsha K. Rajasimha, MS, PhD & Sharlene Brown, PhD Clinical trials are the regulatory mechanisms agencies like the Food and Drug Administration (FDA) use to evaluate and review evidence of safety and efficacy of investigational […]
Data ownership as leverage in accelerating rare disease drug development? Finally, there’s a cloud software that empowers patient groups!
Patient groups can optimize patient registries, cross-sectional studies, and/or longitudinal natural history studies to maximize collaborations with sponsors of orphan drugs and gene therapies
Avoid these 5 real-world data pitfalls when planning your patient registry, cohort study, or observational clinical study
By adopting a checklist of key features or metrics that matter for your particular study, you can select a flexible software solution that best fits your clinical research needs. Then, you’re off to the races, track study progress, create data summaries, and prepare for regulatory compliance audits—all in one place. Following the 5 steps noted to overcome common research pitfalls can maximize the probability of success, save about 70% burden (hundreds of hours), and ensure great user experience in your clinical study.
By Harsha Rajasimha, Ph.D., Founder and CEO The precision medicine paradigm is all about targeting medicines to patient cohorts that are most likely to benefit from them. Since the one-size-fits-all model has been shown not to work, […]
This Startup is on a Mission to Decentralize Cell and Gene Therapy Clinical Trials Author: Steven Surdez, Principal at StoryCore; Article originally published on Biobuzz.io Feb 2020 For the cell and gene therapy revolution to be fully realized, […]