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 challenges](/sites/default/files/images/case-study/american-biotechnology-corporation-pivots/the-challenge.webp)
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
![American biotechnology corporation pivots to decentralized clinical trials American biotechnology corporation pivots to decentralized clinical trials](https://www.hcltech.com/sites/default/files/case-study/images/2024-03/the-objective.webp)
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 Solution](/sites/default/files/images/case-study/american-biotechnology-corporation-pivots/the-solution.webp)
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
![The Impact](/sites/default/files/images/case-study/american-biotechnology-corporation-pivots/the-impact.webp)