Clinical trials are a crucial part of the medical research process for all patient communities. These trials help researchers determine the safety and effectiveness of new treatments and drugs, as well as identify potential side effects and other factors that may affect patients' health and wellbeing. However, conducting clinical trials for rare diseases comes with a unique set of challenges that can make the process more difficult and complex than trials for more common diseases.
Who knew my medical background would place me in the center of supporting decentralized trials?
Steve Nair, M.D.
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The clinical research community is continually called to modernize its approach to clinical trials. More recently, this push is attributed to the passing of the Food and Drug Omnibus Reform Act (FDORA), intended to reshape clinical trial design and operations.
ScienceMedia and Halloran Consulting Group (Halloran) recently collaborated during a Halloran-hosted CORE Retreat - a Clinical Operations Retreat for Executives - in the Boston area. The connection between these companies is simple. They understand the proven need to provide results-driven and multi-media format training to sponsors operating clinical trials across all phases of the study.
How Protocol Compliance Management Enables On-The-Job Competency and Operational Efficiency During the Great Resignation
Halloran Consulting Group launched CORE East over two decades ago - a Clinical Operations Retreat for Executives - which is an invitation-only meeting that brings together an exclusive group of senior leaders in clinical development to discuss and debate the most pressing issues around the business of product development and building enduring life science companies.
To use a sports analogy, protocol deviations and violations in a clinical study represent unforced errors. The application of proper study training, like that delivered through SMi TrialTM, ScienceMedia's Protocol Compliance Management platform, has been proven to reduce and eliminate these entirely avoidable mistakes.
Decentralized Clinical Trials (DCTs), and their near cousins that apply a hybrid approach of in-person and remote visits, are increasingly seen as a viable solution for the conduct of clinical trials.
What working with clinical trial participants taught me: we all want the same thing, being heard and feeling safe.
Facilitating the human connection in decentralized clinical trials
Evaluating potential technological barriers among participants can help to improve study outcomes
My journey from participating in a trial, to supporting them.
Over the last four years at ScienceMedia, I have worked with dozens of study teams to understand the unique operational complexities of their clinical trials.