Top 4 Considerations You Can’t Afford to Overlook
by Raphael Yaakov
Conducting a clinical study is a challenging and costly endeavor with many complex moving parts. Finding the right partners early is a critical success factor. With competing priorities, however, identification and qualification of technology vendor may be put off. Engaging a technology vendor early in the planning process has several benefits. The right technology partner can help streamline complex processes or workflow and fast track study kick-off, patient enrollment, data review and adjudication. A number of considerations come into play on vendor qualification; here are the top 4 you can’t afford to overlook:
1. Breadth of expertise & experience:
Track record in managing complex wound care imaging studies is crucial for a success of a trial. An experienced team can offer a wealth of resources and insights to guide your team from early pre-studies activities to study close-out. It is not unusual for study teams to have limited knowledge or expertise around imaging technologies, central review and adjudication. An experienced imaging partner will be able to guide and inform the development of imaging charters and manuals and help close gaps to de-risk the study.
2. Regulatory compliance and quality assurance:
Regulatory compliance is a must. Be sure to check that the imaging system has been clinically validated and meets applicable regulations. Accuracy and precision are paramount in imaging studies, and thus it essential to consider intra-and-inter-rater reliability of the device. Devices with poor test-re-retest statistic can introduce system bias and variability in the data. Furthermore, it is important to confirm that system features meet HIPAA/GDPR and 21 CFR Part 11 regulations and offer a comprehensive audit trail.
3. Service time, availability & flexibility:
Study delays are costly. Time to start-up, delivery or completion, response time, percentage of tickets closed are important metrics to consider, and should be balanced with team’s capability to adapt as study needs change. Amendments may impact budget and resources significantly. Is your imaging partner able to react quickly and flexibly? Is the development team able to append changes with minimum downtime or disruption to workflow? Is team available when you are? Your technology partner should be receptive and flexible. Effective collaboration between multidisciplinary teams across organization is a must.
4. Approach and long-term partnership:
Does your imaging partner fit your short and long-term need? This is a multifaceted consideration that goes beyond pre-qualification for a study. Experience, technology and approach, and company culture are all part of the equation. A good imaging partner will help increase efficiency and quality. They are able to move with speed and quickly address challenges. A right partner will be strategically poised for growth, innovating, and implementing new technologies and process improvement.
About the Author
Raphael Yaakov serves as the VP of Clinical Development at eKare, Inc.. His experience spans across public health, clinical research, and technology. He has helped support key initiatives in patient education programs, global epidemiological surveillance to managing phase I-IV multinational drug and device studies. He completed his undergraduate course work in life sciences at the Pennsylvania State University and holds a MS with a concentration in pharmacoeconomics and outcomes research from University of the Sciences in Philadelphia.
About eKare
eKare is a physician-led digital health and AI company committed to providing unparalleled solutions for advanced wound imaging and data analytics. With combined 50+ years of experience in clinical research, the eKare team has supported over 150+ clinical studies across the globe. As a trusted industry partner, eKare continues to advance wound care technology to improve care delivery and patient outcomes.
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