The Challenge
To make clinical trials easier for patients, our client was looking for a solution to support end-to-end remote trial management on a global scale, from patient recruitment, engagement and management through post-market clinical surveillance.
The Objective
Accelerating patient recruitment
- Improving the low volume of patient recruitments related to early withdrawal during initial stages of trials
Site activation and management
- Shorten study start-up/activation with reduced contract negotiations and fewer site training needs across multiple locations
Regulatory compliance
- Improving and ensuring compliance with regulatory guidance, including HIPAA, GDPR, 21 CFR Part 11 and EU Annex 11, needed for a successful trial
Digital patient engagement and assessment
- Implementing a tele-visit platform for caregiver-patient communication to streamline risk management
Improve patient monitoring
- Leverage medical devices and wellness questionnaires to collect real-time patient information to improve patient monitoring and reduce the risk of adverse events
The Solution
To enable faster clinical trials, improve the experience for both patients and doctors and accelerate the pivot to bringing the trials to patients rather than patients coming to a trial site, HCLTech designed, developed and deployed the Decentralized Clinical Trials (DCT) solution.
As part of the engagement:
- HCLTech provisioned, configured and deployed medical devices as part of the patient enrolment and onboarding process.
- DCT solution’s patient mobile app provided the ability to capture and securely transmit electronic patient-reported outcomes (ePRO) and wearable device data to an AWS IoT platform. This data was then visualized by the doctor to ensure patient well-being and trial compliance.
- DCT used ‘direct to patient’ interaction technology, leveraging wearables and home-based physiological devices that helped pharmaceutical companies reduce study timelines, lower site burden and speed enrollment by screening and consenting patients remotely.
- The solution provides multilingual global study support through provisioned and/or BYO devices, patient and site support services and on-demand custom reports at the study, site and patient levels.
The Impact
- Enhanced data collection through remote health monitoring
- Reduction in patient burden by introducing telehealth capabilities
- Eliminated geographic boundaries from the patient recruitment process
- Seamless integration with CTMS and medical devices in a regulatory-compliant manner
- Enhanced patient experience by delivering robust training and support structure
