Medable’s flexible and easy-to-use solutions, including eCOA and ePRO enabled this company to transition from an in-office setting to remote, all while ensuring site and patient connectivity with real-time data flow.
Study teams today face challenges identifying and implementing eCOA technology solutions that meet their unique protocol’s requirements. These problems became even more apparent during the current COVID-19 pandemic when studies of all kinds came to a screeching halt. One such example was a life science company focused on auto-immune and inflammatory conditions.
This company collects and provides access to longitudinal clinical data for pharmaceutical development and commercialization. Their mission is to advance patient care and improve treatment with real-world data analysis. Until the pandemic, the company’s sites collected all data on-site, via paper format questionnaires. The workflow began in the confines of the patient’s regular physician appointment where they were asked to participate in the registry. If the patient agreed and consented, the patient retreated to the waiting area and completed a paper questionnaire. The questionnaire was then processed by multiple staff members who each added data before finally entering into their system, an inefficient use of time that also included some risk of privacy, security and transcription error.
Between data quality risks and at-risk patients that needed to minimize face-to-face interaction, they had to find a way to continue data collection by rapidly transitioning to a digital model. Like most life science organizations, the company sought a technology-focused solution that would allow them to continue enrolling patients and collecting data in their registries. Virtual participation would not only be more patient centric but more efficient as well.
Medable eCOA was developed using protocol fit design. The solution parsed paper forms into a logical digital experience with associated workflows targeted specifically to each role and persona (PI, Coordinator, Patient). This enabled the company’s core registry business to continue. Key registry functions were digitized into a single platform:
- Physician enrollment of patients
- Patient completion of questionnaires
- Patient outcomes data collection
The new process minimized risks to data quality by removing the need for duplicate manual data entry. Medable eCOA also mitigated risks of data security by discontinuing the paper questionnaire that could be lost, misplaced or viewed by another patient or family member. Additionally, patients now had the option to complete the questions in comfort and privacy on their own, without spending more time in the physician’s office. Through this process over 200 patients were engaged and enrolled into the digital solution. As a result, site staff can now spend more time providing clinical guidance and support directly to patients, expand access to more potential participants, and increase the capacity for additional studies.
How we did it
Medable’s eCOA solution has the unique ability to handle complex workflows and power the entire decentralized clinical trial process. Understanding that each client has unique needs, Medable’s eCOA platform is flexible and adaptable. For example, the company needed a way to compensate patients for participation in this new digital environment. Medable was able to do a back-end integration with a payment processor that triggered an electronic payment to the patient once a digital assessment was completed.
Flexibility, seamless integrations, and third-party workflows are commonplace for Medable. The technology platform is also designed to transform with business needs through the ability to rapidly configure new assessments using streamlined, out-of-the-box capabilities without the need for timely customizations.
Medable eCOA’s flexibility enabled this research organization to manage their ongoing and new engagements between patients and sites in a short time period, alleviating the impact of COVID-19 travel restrictions while improving patient choice and satisfaction.