Newark, Delaware, April 22, 2019 – QPS, a global contract research organization (CRO) providing discovery, preclinical and clinical drug development services, today announced its successful implementation of ClinSpark, an eSource technology platform for Phase I automation, to support double digit growth in Phase I clinical trials.
According to Grandview Research, the global clinical trials market size is currently estimated at $44.2 billion and is anticipated to expand at a CAGR of 5.7 percent by 2026. “At QPS, our Phase I clinical trial revenue is growing 15 percent year-over-year, nearly three times as fast as the total global clinical trials market,” said Wim Tamminga, Ph.D., VP, Global Head of Early Phase Clinical, QPS LLC.
To support this growth QPS has chosen ClinSpark as an eSource technology platform, creating efficiencies in the operational process and delivering real-time study data to its clients.
Most mid-sized CROs have adopted Electronic Data Capture (EDC) systems. However, they still very much rely on paper-based source data. “Every Phase I study generates approximately 300 data points per subject,” said Tamminga. “When you multiply that by thousands of subjects, that’s a lot of data. And, right now, most mid-sized CROs are capturing that data on paper and manually entering it into their EDC systems.”
Digitization of clinical research should begin at point of data collection. With ClinSpark, QPS is transitioning from paper-based data collection to digital data collection. “All of our Phase I clinics will be paperless within the next few years,” said Tamminga. “We just completed the implementation of ClinSpark in the Netherlands and are now rolling it out to our remaining Phase I sites around the globe.”
ClinSpark, developed by Foundry Health, eliminates transcriptions and facilitates the digitization of clinical research by enabling:
- Medical devices that electronically capture subject data, such as ECG and vitals, to import the data directly into an electronic system.
- Medical staff to use mobile devices – rather than a paper-based documents – to capture and review subject data.
- Barcode scanning technology that supports identification and navigation purposes.
- Lab integration that automatically creates lab orders and collects data from internal and external safety labs, providing real-time crucial safety information.
QPS excels at complex and special population Phase I trials, and its enrollment and completion rates are among the best in the industry. ClinSpark will enhance Phase I study recruitment by delivering real-time insight into the recruitment status of every study.
“If you collect data on subjects as they make their way through the recruitment funnel, you can see where issues are happening with recruitment,” said Tamminga. “For example, if a high number of volunteers are failing a particular screening assessment, we can look at the data and make recommendations to adjust the parameters to widen the recruitment net, while maintaining the safety and validity of the study.”
ClinSpark is a Phase I automation solution developed by a team with experience working in Phase I units. “QPS chose ClinSpark because the technology platform is modern, cloud-based and completely up to today’s IT-standards. It is built by people who have run Phase I clinical studies and understand the specific challenges inherent to Phase I,” said Tamminga.
Implementing ClinSpark was done on time and within budget. Close collaboration between QPS and Foundry Health resulted in a successful, four-month implementation timeline. “There was a strong spirit of cooperation between both teams. At Foundry Health we have a very pragmatic hands-on and solution-oriented attitude and we were very pleased to experience exactly the same on the QPS side,” said Steffan Stringer, Operations Director of Foundry Health.
eSource implementations can become massive with high upfront license costs incurred before any benefits are realized. “One of the benefits of ClinSpark is that it is offered as a SaaS solution, which keeps upfront investments low and aligns costs with reaping the benefits of using the system. This made it the project with the highest ROI ever implemented at QPS,” said Tamminga.
“At QPS we dose about 3,000 study subjects every year – that’s nearly a million datapoints a year and growing,” said Tamminga. “ClinSpark will dramatically improve our efficiencies and give our clients immediate access to study data. The faster our clients can access study data, the faster they can make decisions. Timely decisions shorten study timelines and improve outcomes.”
About QPS Holdings, LLC
QPS is a global contract research organization (CRO) providing discovery, preclinical and clinical drug development services since 1995. The company accelerates pharmaceutical breakthroughs across the globe by delivering custom-built research services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. For more information, visit www.qps.com or email [email protected].
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