Tranquil Clinical Research: Ensuring Operational and Well-Being Success in Clinical Trials
It seems like there is an age-old question that every organization faces at one point or another: how do you know when to look externally for a solutions provider that will offer you exactly what you need while being able to deliver on a quality-based and full-scale solutions framework? The answer might be: when you start to realize the actual depth and breadth of the challenges you’re facing.
Clinical trials are complex environments that need expertise and reliable solutions to be successful. Tranquil Clinical Research is just the Clinical Research Organization that specializes in Phase One, offering a full-scale set of solutions unique to different trials, including enrollment delivery, data management, safety measures implementation, and operations management.
Karim Mohammed, President and CEO of Tranquil, explains how, “Our flexibility and our ability to navigate clinical trials and eliminate the challenges is what makes us deliver on actual results. We look at every project and we mitigate the problems that might happen in that trial. Our objective is: how can we deploy a trial that keeps our patients safe on study while enabling the sponsor to also achieve the data they need from patient enrollment?”
Patient enrollment often acts as a barrier in clinical trials due to the multifaceted and complex nature of procurement, enablement, testing, and assurance that’s needed. “Sourcing healthy volunteers is more than achievable because Tranquil is in the most diverse city in the United States,” Mohammed explains.
Phase One is a notoriously difficult area within the clinical trial lifecycle. It involves everything from patient enrollment and planning to organization and reporting metric creation. Interestingly, Tranquil is not only a CRO but also a freestanding unit, meaning they’re able to understand the complexity of patient recruitment and enrollment as well as plug in data so it’s reliable, stored safely, and protected. “We’re very much a site management service provider that way,” Mohammed says. “And we’re able to solve the data problem that everyone is facing.”
It works like this: Tranquil uses a host of project management tools, including Microsoft Project, as well as their own clinical trial management platform. “We have a KPI and a KRI navigator that helps us manage key performance indicators and key risk indicators. Then it comes down to the user of the platform that we involve ourselves in understanding,” Mohammed explains. Tranquil’s platform is not a one-and-done deployment solution. Instead, Tranquil works closely with the sponsor to understand the trial, get at some of its complexities, and build solutions that are tailor-made to address their foremost needs. Meanwhile, because timelines are crucial in clinical trials, Tranquil utilizes Gantt charts as well as other timeline-tracing tools to help a project stay on track.
Offered to each sponsor is an executive oversight model that greatly increases the level of confidence and certainty that sponsors can build their clinical trials out of. “I personally meet with every single one of our CRO clients at a set frequency of at least every three months. But I meet with some of our clients every two weeks because they’re small. We’re very patient with our sponsors and we do a lot of teaching, but it’s also about understanding the problems in the study. If you identify them early based on the relationship we build, we fix things so quickly,” Mohammed explains.
Beyond the nuts-and-bolts of a clinical trial, however, is the need to also ensure well-being which, historically, has been overlooked in some clinical trials. “In our early phase oncology trials, sometimes we’re the only site running in the world because we’re the fastest site to get it up safely. We produce wellness outcomes because our focus is wellness rights and safety. We prioritize that,” Mohammed adds. Part of wellness assurance includes patient privacy, and Tranquil is exceptional here too. “Patients feel that they have some privacy. For example, we can put up pony walls and they have this place where they can go where no one’s staring at them. When you elevate well-being, you maximize. You get the best data because you break the barriers of attrition, you break the barriers of why isn’t data getting entered? You break the barriers of individual error,” Mohammed says.
Tranquil is helping all sizes of sponsors overcome these challenges, no matter how small they may be. Tranquil’s commitment to finding the right approach for every sponsor, alongside the ability to aid clinical trials while keeping each party involved, speaks to their overall quality of design and intent.