Below is our recent interview with George J. Atiee, M.D., vice president, Medical and Clinical Lab Director at Worldwide Clinical Trials:
Q: Talk to us about the top challenges of completing a phase 1 trial. How does the technology that is available impede/facilitate progress?
A: Phase I trials focused on first-in-human studies and early clinical development are increasingly complex, highly scientific in nature and under tight timelines. At the same time, study sites struggle with labor-intensive data collection and transcription processes.
The many stages of study design are complex, and with countless vendors ready to support, it starts to get confusing where to begin.
It’s also easy to be dazzled by new technology or being stuck in a rut of forcing your trial into using a trial system you already know.
The results are inflated costs & compromised quality.
We prioritize data quality & patient safety, since they are so critical to trial success. It’s vital to have streamlined, accurate data transparency throughout the trial process.
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Q: So where do you start when it comes to vetting technology solutions for a phase I clinical trial?
A: During the vetting stage, it’s important to leverage technology where it makes sense to solve the problems I have just outlined above.
When people don’t have access to the right technology, they experience those issues.
It’s important to find a provider that can offer a transparent data view throughout the entire trial process.
Q: Tell me more about this new early phase technology you recently implemented at Worldwide, ClinSpark.
A: We have this innovation agenda to change this dynamic by delivering real-time access to high-quality data throughout the process. This is critical to delivering the same level of customer focus people have come to expect in other areas of their lives. The study team should be able to design and implement clinical trials that give the right answers, in the most simple and unobtrusive way possible for patients, sponsors and regulators.
We’re really excited about ClinSpark, because it is helping us accomplish this.
Q: What is ClinSpark?
A: It is an eSource platform for Phase I clinical trial automation by Foundry Health.
This web-based electronic data capture system allows all Clinical Pharmacology Unit (CPU) systems and devices to connect into ClinSpark, for access to all study data in one place.
Q: How many studies have you completed using this technology?
A: 40 initiated and completed studies using ClinSpark.
Q: What does ClinSpark enable you to do?
A: Specifically designed for Phase I trials, ClinSpark is CDISC ODM certified, Part 11 compliant and HIPAA compliant. It supports the total process from recruitment through data collection and all the way to data export. It provides barcode support and countdown timers, as well as integration with virtually any medical device, such as vital signs monitors and electrocardiogram (ECG) machines. It has a bidirectional interface with Worldwide’s clinical laboratory.
ClinSpark enables Worldwide to accelerate the time from study set up to database lock. ClinSpark also enables real-time electronic data and remote data monitoring, as well as statistical analysis with real-time visualization of data to reduce documentation errors. And, ClinSpark marries procedure to equipment use, enabling efficient equipment management.
Q: What are the key learnings from this new technology?
A: Worldwide is making a visible difference by transforming clinical trials to be more rewarding for patients and sponsors by replacing manual processes with innovative technologies that result in richer, more accurate data.
ClinSpark gives me instant access to the critical information required to monitor the progress of our trials – anywhere I can access the internet. We are improving logistics, patient communications and data reporting, all of which are critical factors in keeping trials running smoothly and efficiently.
Q: Can you tell us something more about the company and what you do?
A: Worldwide is a full-service CRO providing services in a variety of therapeutic areas including CNS, cardiovascular/metabolic, oncology, general medicine, rare & orphan disease.
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Q: Who are your clients and what are some of the key challenges you’re helping them solve?
A: We’re helping small to midsize pharma and biotech companies navigate the ever-changing demands of the FDA and shortening timelines as much as possible.
Q: What makes Worldwide uncommon?
A: We’re not part of the herd. We have a global reach, an extensive network, unmatched patient recruitment, “in the trenches” expertise, and a commitment to excellence.
At the very beginning of our relationship, we tailor our methods to be in line with your company goals and culture so working with us is easy — like working among your own colleagues and with familiar processes. We want to work together to meet your clinical trial needs as a true partner.