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 […]
Traditional clinical guidelines, and stand-alone patient study and care pathways are proven to be increasingly inadequate, especially in a post-pandemic world with low clinical adherence, disrupted workflows, and stay-at-home orders. Disrupted workflows means more time required to […]
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 […]
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 […]
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 […]
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.