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 […]
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
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, […]