Research Reimagined: 4 Pillars to Support the Future of Phase I Clinical Pharmacology

Research Reimagined: 4 Pillars to Support the Future of Phase I Clinical Pharmacology

The 21st century has opened up a new frontier for clinical research. Advances in data collection have produced massive data streams, and innovations in digital monitoring have made patient participation more flexible than ever. At the same time, Phase I research remains rooted to rigid regulatory guidance and design, forcing it to lag behind its more pioneering late phase counterparts.

At Dr. Vince Clinical Research (DVCR), it is our belief that all studies deserve the absolute best in planning and operational conduct. This conviction is built on the foundation of our four pillars, which helps us rethink the standards and expectations of Phase I clinical pharmacology. The result is completely reimagined research, informed by the essential tenets of who we are as leaders in early phase execution.

1. We are intentionally designed for research.

Most research facilities are repurposed, constructed or expanded piecemeal as budgets allow or as more bed space becomes necessary. Even if their planning is more strategic, these facilities are designed with limited fiscal freedom, which inevitably leads to compromises during development and a less efficient environment for study execution. DVCR was designed differently, recruiting world-class experts with proven track records and sparing no expense on the finest equipment for every application. Our cutting-edge center was built from the ground up with one precise purpose: providing the optimal atmosphere for successful Phase I research.

Clinical research is already a slow-moving industry. The added caution required in early-phase studies, combined with the fragmentary development of most facilities or site networks, makes it difficult to simultaneously capitalize on all the improvements inherent in modern study execution. However, when you start with a clean slate, much like the Dr. Vince Clinical Research Center in Kansas City, you can hit the reset button. You can rethink and reimagine each piece of your facility and each efficiency in your procedures AS they are being built, then start things anew with truly intentional design.

2. We are envisioned around technology.

DVCR began its earliest planning with a mind toward innovation, then envisioned every step of development around achieving comprehensive and thoughtful tech integration. Many studies, especially those focused on Phase I clinical pharmacology, incorporate the latest technology with only partial success, whether because necessary equipment is missing, staff are not properly trained or the site itself isn’t structurally compatible. To that end, they are conducting their research in the past, unable to power their results with the smarter, faster data® of today and tomorrow.

DVCR is designed for comprehensive and adaptable integration that not only harnesses the most cutting-edge technology of today but also adjusts to the groundbreaking innovations that will drive tomorrow’s research. Our 90-bed clinical pharmacology unit incorporates cutting-edge modern amenities, luxurious suites and an on-site GMP compliant pharmacy capable of positive and negative pressure compounding. This forward-thinking design features an eSource with equipment integration for automated data upload, integrated building and inventory management systems and wifi telemetry monitoring. These integrations open the door to faster, fully encrypted data achieved through more purposeful tech enhancements and operational excellence.

3. We are powered by people.

Employee retention is vital to industry expertise, yet nearly 1 in 5 research sites have turnover rates higher than 30% (1). Highly competitive benefits are key to attracting quality research personnel, and a positive, collaborative culture is the only path to turning new team members into tested, well-rounded experts and respected industry leaders. Unfortunately, large sections of clinical research, many of them found in Phase I specializations, suffer from even lower retention due to highly demanding, narrowly focused fields of study. These sites and site networks find it especially difficult to attract qualified and innovative leaders and team members with proven Phase I success. As a result, their protocols and procedures are not informed and enhanced by specialized expertise. Instead, they are handicapped by the inconsistencies of high turnover.

At DVCR, we invest in people, which makes our expert insight peerless and comprehensive, supporting everything from protocol design and feasibility analysis to the most advanced clinical conduct. We offer some of the most competitive benefits in the area, which uniquely positions us to cultivate excellence over the long term. Additionally, each member of our diverse leadership team was hand-selected to provide expert yet practical insights into every facet of study execution. The result is guidance that fills you with confidence and pushes your research toward the finish line.

4. We are committed to the environment.

It is long past time for clinical research to reckon with its environmental impact. Despite a “golden age” of digital innovation, there is often very little environmental stewardship behind the biggest advancements in the industry. To truly prepare for the future, clinical research must transition to greener facilities and more eco-friendly environmental solutions, maintaining maximum efficiencies while pushing Phase I research toward a more sustainable future.

DVCR prioritizes its relationship with the environment, opting for industry-leading green design in its construction and cutting-edge conservation strategies tied directly to its resource usage. Our center is powered by over 500 solar panels, provides access to car charging stations and utilizes demand-controlled ventilation. This intentional design has resulted in the submission for multiple Green Globes Building Certifications, a comprehensive, science-based rating system with rigorous environmental standards. By confronting the responsibilities of our research from the beginning, DVCR is better prepared to respond to the changing future of regulatory guidance.

Conclusion

At present, the standards for Phase I research are not steering the industry toward technology-based conduct. Study and facility designs lack intention, technology is underutilized, expertise is fleeting and inconsistent, and there is little to no regard for the environment throughout the process. DVCR is shaping the future of Phase I clinical pharmacology by challenging the inadequacies and inefficiencies in modern study execution and reimagining Phase I clinical research. Our center is designed differently, guided by smarter faster data®, more advanced technology, more valued personnel and more thoughtful design. At DVCR, we are intentionally designed for research, envisioned around technology, powered by people and committed to the environment. For more information on conducting your trials at our cutting-edge Phase I center or requesting our first-class support services, contact us now. 

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1 Miessler, J. Critical Challenges Persist for Sites in Staffing, Enrollment and Protocol Complexity. CenterWatch. Published 2021 Nov. 15.

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