Clinical trials (CT) are the long and complex processes for bringing novel medical products to patients through the regulatory process of evaluating the safety and efficacy of treating specific medical conditions in humans. In addition to […]
As new non-COVID-related clinical trials proliferate, the need for effective global decentralized CT management is becoming even more apparent. What is needed, says Dr. Harsha Rajasimha of Jeeva Informatics, is to expand the capabilities of validated […]
The COVID-19 pandemic brought a new sense of appreciation for clinical trials as masses watched clinical trials closely while pharmaceutical companies raced against the clock to find viable vaccines and drugs for the Coronavirus outbreak with […]
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 […]
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.
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, […]