eCOA Solution Design Recommendations: Applied Insights From Trial Sites, CRAs

By Bill Byrom, Ph.D., VP Product Intelligence and Positioning

The clinical development industry is increasingly recognizing technology as pivotal in shaping the future of clinical trials. Shifting away from the traditional site-centric model, there's a notable transition towards patient-focused paradigms that leverage technology to minimize in-clinic visits. Decentralized clinical trials are at the forefront of this evolution, integrating telemedicine and mobile healthcare providers to enhance flexibility and accessibility.

Digitalization in clinical trials encompasses various components: remote data capture, electronic informed consent, telemedicine services, patient engagement applications, study supply management solutions, virtual site monitoring, and home health options. These advancements not only enhance data quality and patient engagement but also alleviate the workload on clinical research associates.

Yet, challenges persist in adopting technology, particularly in managing logistics and regulatory requirements for lab samples and outpatient sampling technologies. Effective planning of hybrid trials from inception, alongside stakeholder collaboration, is crucial to overcoming these challenges and embedding flexibility into trial protocols.

Sponsors are encouraged to explore how technology can optimize data quality, participant engagement, compliance, and overall trial success. Collaborating with experienced partners equipped with advanced technologies ensures the implementation of robust virtual platforms, secure connectivity, mobile solutions, wearables, and the integration of artificial intelligence and machine learning for data analytics—all essential for the seamless execution of hybrid trials.