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 Trial ScienceMedia's Protocol Compliance Management platform, has been proven to reduce and eliminate these entirely avoidable mistakes.
In the same way a coach provides pre-season training on fundamentals and then relies on practices and drills throughout the season to reinforce that training, SMi Trial can be counted on to not only provide foundational study education at start-up but also to continue that education throughout the life of a study. And, rather than having to rely solely on scheduled "practices," SMi Trial delivers on-demand training to match the needs of busy study staff for a flexible training solution that fits their schedule. It's like having a private coach.
Just as an experienced and effective coaching staff helps to field a winning team, the power behind the SMi Trial platform begins with its staff of seasoned medical writers and educational designers. Together, they employ established learning principles to craft concise, effective, and engaging modules that key in on the critical areas of a study. This focused approach targets those study requirements most at risk of being misunderstood or those areas where failure to comply will have serious consequences. The benefit is a study team that is well versed on study principles and practices, and aware of potential pitfalls to be avoided.
Simply put, I wouldn't back a sports team without a coach. So how are clinical trials running without protocol compliance management?
Prior to joining ScienceMedia, Mr. Geckeler logged over 25 years in the pharmaceutical industry working on the clinical development across a wide range of product formats and therapeutic areas. Most recently, Robert served as the Chief Development Officer for Sitka Biopharma and as a board member for Cerion NRx. In addition, Robert previously led client services and product expansion at OneHealth, an online and mobile platform that used social networking, coaching, and disease management programs to support users with chronic medical conditions. Robert has a B.A. in Biology from Washington University in St. Louis and an MBA from San Diego State University.
For moviegoers, Morpheus' line, "Unfortunately, no one can be told what the Matrix is. You have to see it for yourself," followed by an offering of a red or blue pill to Neo, brings us right to the scene in the mega blockbuster hit, The Matrix.
As we reflect on this past year, let's close out 2023 by acknowledging the great strides pharma has made. Who's on board for some levity? If you are, read on.
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.
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.
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.
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.
