To be competitive in the next decade, pharmaceutical companies must meet rising customer expectations. Consumers demand alternatives that are clinically and economically superior to existing products, proven with solid, real-world outcomes. The impact of big data in pharmaceutical R&D is enormous. The era of personalized medicine is here. With technology from Zeblok, pharma companies now have the means to collect real-world evidence from study subjects early in the clinical lifecycle during the journey from molecule to medicine.
This is a step beyond mere creation of awareness; companies can now employ real-world data to decide which agents to advance through the development pipeline—and which to withhold, based on early, monitored observations of side effects not previously distinguishable. At Zeblok, we have created a unique platform for collecting real-world evidence from gait, sleep, and any other biosignal of interest. Securely. Wirelessly. Naturally—with devices that study subjects already use, such as shoes and beds. #RealWorldOutcomeMeasures from Zeblok are what clinicians, study sponsors, and CROs demand.
Sponsors need to make better decisions faster during clinical trials. On-study data acquired directly from subjects in typically unmonitored home and community settings is extremely valuable but very difficult to obtain. Zeblok allows passive collection of gait, sleep, and other data and thereby provides opportunities to expedite and reduce the costs of drug development.
The future of clinical trials entails truly unbiased data collection. Zeblok allows study subjects to continue their daily routines without interruption or interrogation to collect biosignal data; this provides a better value proposition for study subjects as well as family members and enhances subject engagement.
Until now, transitioning electronic data capture (EDC) to mobile platforms was considered state-of-the-art. Zeblok advances far beyond this by providing a comprehensive blanket of intelligent, linked, and integrated devices to fully automate collection of physical, real-world datasets not easily captured by merely querying study subjects themselves.
Remain at the forefront of data capture, feature extraction, visualization, and analytics in clinical trials through simple, bespoke integration of the Zeblok platform. Comprehensive data-collection and analytics are easily customizable to meet the specific needs for each clinical study.
The 2016 Technological Innovations Survey Report from SCORR Marketing and Applied Clinical Trials demonstrated that pharmaceutical companies and CROs are extremely accepting of new processes or technologies in clinical trials and adoption of use of big data. Zeblok addresses stated concerns about technology implementation by providing secure data collection and storage, verified clinical data quality, and the only cost-effective means to obtain such novel data.
The clinical trials service market is expected to grow from $38.4B in 2017 to $64B by 2020. Real-world data capture from Zeblok can provide an enormous return on investment by reducing the overall costs of clinical studies through accelerating decisions about product viability much earlier in the clinical study process.
The Zeblok platform allows automated, continuous analysis of real-world parameters heretofore unmeasurable within the subject’s natural environment, including stride symmetry and length, heel-to-toe strike ratio, stride cadence, foot tremor, swing time, and quantifiable balance and instability.
Non-obtrusive real-world, real-time data collection is necessary both within clinical settings as well as the comfort of a subject’s home environment to eliminate bias or artifacts of white-coat syndrome. The Zeblok platform provides instantaneous evaluation of respiratory rate dynamics, periods of motionless, restful, and restless sleep, mattress pressure variations, and other customizable outcome measurements.
Respiration tracking is important for subjects with intellectual and developmental disabilities or respiratory debilitation. Zeblok provides technology to augment remote monitoring for otherwise important physiological signals such as blood pressure, temperature, and blood oxygen saturation while correlating changes with real-time detection of variations in respiratory rates.
The Zeblok platform employs a combination of contact sensors (wearables, pressure pads) and non-contact sensors (motion-sensing cameras, door contacts, microphones) to infer activities of daily living (ADL) and identify patterns in ADLs to ascertain required interventions or the quantum of assistance by loved ones and care providers necessary for safety.
Zeblok’s powerful and patent pending platform allows CROs to create additional value for their customers by augmenting clinical trials with hard-to-find real-world data. Analysis and integration of novel datasets by CROs enables sponsors to comprehend and rapidly evaluate additional outcome measures based on real-world evidence.
Zeblok’s cellular-linked sensors allow real-world gait and mobility data collection within registry studies, in which physicians treat the index condition as they wish and sponsors remain passive observers. Such real-world data help sponsors with post-approval efficacy determinations as well as publications.
Zeblok’s mobile app—working in concert with a wireless middleware platform, sensors, and edge devices—is an effective medium to deliver insightful condition-related messages and branding to subjects participating in clinical trials. Additional value is created in presenting general wellness data (including sleep and activities) as well as pertinent alerts to caregivers through the app, enhancing safety and triggering acute responses. The Zeblok mobile app effectively deepens the relationships with patients, resulting in enhanced patient engagement.
Ask us how we can easily implement a custom, real-world Zeblok data collection platform tailored to your needs which will significantly reduce your time to market and technology risk.