eClinical Research for Cardiac Safety, eCOA, Healthcare and Respiratory Endpoints

The ERT Innovation Lab is the evolution of a company known for its innovations and first in-the-industry features. ERT Scientists were the first to develop and deploy electronic diaries in a research setting, first to study and document patient non-compliance with paper diaries, first to deploy wireless electronic diary (eDiary) solutions to collect electronic clinical outcome assessments (eCOA), and first to deliver:

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  • Electronic Holter ECG Trial (1975)
  • PEF and Glucometer Integrations with an eDiary (2005)
  • Barcode Reader Integrations with an eDiary (2013)
  • eDiary Medication Module (2014)
  • Electronic Spirometry with Biometric Security and Risk-Based Monitoring (2014)

To accommodate the surging demand for sensor technologies and ancillary devices from pharmaceutical research, medical device manufacturers and healthcare technology entrants such as Microsoft, HP, Intel and Apple, ERT has built an innovation practice area leveraging global resources with partner assets.

The ERT Innovation Lab is home to diverse technologies repurposed for clinical research and broad clinical care. The Lab’s objective is to reduce risk while expanding the art of the possible for pharmaceutical research by facilitating the development of concepts to enhance the variety of research data collected from patients within clinical trials and healthcare.

The Innovation Lab model is based on lean development philosophies and maintains weeks (not months) to return results. Teams are assembled with ERT, industry and partner assets to employ rapid prototyping, patient preference / usability testing and ongoing regulatory compliance analyses.

The ERT Innovation Lab focuses on projects that are time boxed, allowing for targeted commitments from all parties invested in the problem statement and keeping budget requirements to a manageable target. Collaboration partners may provide funds and resources to achieve the target and derive lessons learned. Innovation projects include initiatives in the Internet of Things (IoT), consumer medical device assessment, data analytics, new hardware components (video, audio, etc.) and process improvement (logistics, trial management, data management, etc.) for clinical research and wearables for clinical care.

The ERT Innovation Lab is an irrefutable model that is already generating industry research innovations, enabling industry to take bigger steps in applying the Internet of Things to new medical product development and advancing technologies to satisfy payer needs for more efficient and available healthcare.

By establishing the Innovation Lab, ERT has removed the barriers for industry, enabling research to embrace new medical technologies and fostering an environment for them to think more broadly about how to evaluate the complete patient and investigator experience during clinical development and clinical care. ERT has insulated industry research from any risk of patient adoption and regulatory acceptance: Lab innovations are independent of any trial and trial timelines. The model has proven successful for decades; the Lab is now made available for industry collaboration to discover new market advantages.

Incorporating Activity Tracking into Clinical Trials: Fitbit® Charge HR™ Band and Aria™ Wi-Fi Smart Scale

ERT’s Innovation Lab was asked to determine whether daily activity tracking captured by the Fitbit Charge HR Band and weight captured by the Aria Wi-Fi Smart Scale could be used to monitor activity levels of juvenile diabetic patients during a clinical trial. During concept testing, data was extracted from the Band via Fitbit’s backend server, and presented along with patient glucose readings captured via ERT’s integrated electronic patient reported outcome solution, LogPad®. Since the Aria Scale required home Wi-Fi and was difficult to connect, the Innovation Lab concluded it would not be ideal for this cohort. However, the Charge HR Band demonstrated potential for use in clinical trials and is currently being used by the sponsor in a clinical trial.

Tele-medicine Today: Discovering Best Practices for Technology-Driven Communication in Clinical Trials

ERT utilizes locked-down smartphones in clinical trials to keep the device focused on submitting data entered by the patient. A clinical sponsor engaged ERT’s Innovation Lab to open the phone’s voice calling feature to enable direct conversations between the patient and site. The project’s goal was to provide voice calling in a point to point manner. ERT included a SIM chip in the phone and created features built over standard voice SIM usage to restrict calling for clinical purposes exclusively. With the success of this project we expect to see voice calling used in upcoming trials. This project jump started research in the Lab on use of video conferencing in clinical trials.

Experimenting with Wearable Health Monitoring Technologies: Vital Connect HealthPatch M.D.

ERT’s Innovation Lab launched a project to test the integration of ERT’s LogPad with Vital Connect’s HealthPatch M.D, an adhesive patch with a small, battery-powered sensor that continually monitors patient data points such as heart rate, skin temperature, and fall detection. ERT is capturing patient fall detection data from the patch and using it to trigger an episodic electronic diary assessment to capture information about the circumstance of the fall. In an upcoming study ERT will use heart rate, steps, and posture data with LogPad. The patch’s wide array of capabilities makes this an appropriate solution for clinical trials across many therapy areas.

Bringing the Apple Research Kit into Clinical Development

ERT’s Innovation Lab is exploring the Apple Research Kit for use in regulated clinical trials. This open-source software standardizes the collection of healthcare data from the public, making it easier to participate in trials. User-friendly questionnaires and consent forms are created through the Kit’s templates. Many clinical trial sponsors are interested in the Kit, due to its early high adoption rate and the promise of quick access to many potential trial participants. The Lab is exploring a uniform front end for the Kit that will integrate data with ERT’s database and validated solutions. This may set the stage for future development, including the potential to build questionnaires or new features that might be transferrable to others.

Private Innovation Lab Tour in Boston

Private Innovation Lab tour in Boston, MA.

Visit the Lab with your colleagues, meet the dedicated cross-functional team, and discuss prototype and funding opportunities.

Have the Private Innovation Lab Come to you!

Innovation Day:

Full day program including discussion on agreed-upon topics and demonstrations of current innovations in development, delivered by senior scientists and engineers. Includes expanded clinical science services, eCOA Research pipeline including BYOD and the ERT Product Roadmap.

Traveling Innovation Lab:

The Traveling Innovation Lab will visit your location and provide hands-on demonstration of novel patient data collection concepts we are exploring. Certain restrictions and fees apply. Based on availability.

Innovation is not the result of chance, it’s the result of action. It’s NOT a thing to wait for. It’s a thing to do.  – Phil McKinney