The healthcare industry is experiencing a significant shift towards digital solutions, particularly in the area of informed consent.
The global eConsent market is projected to exceed USD 996.61 million by 2031, with a compound annual growth rate (CAGR) of 10.78% during the forecast period. This growth is driven by advancements in mobile technology, cloud computing, and electronic signature capabilities, which have made electronic consent (eConsent) more accessible, secure, and user-friendly.
The integration of eConsent into clinical trials is becoming more prevalent as healthcare institutions strive to streamline processes and enhance patient understanding.
Recent developments in the eConsent landscape highlight the importance of regulatory frameworks and technological advancements.
The European Contract Research Organisation Federation (EUCROF) released a guide in March 2021 aimed at implementing electronic informed consent, emphasizing the need for specific instructions on utilizing electronic signatures in clinical studies.
This aligns with the existing eIDAS regulation, which governs electronic signatures, ensuring that the legal framework supports the adoption of eConsent in clinical settings.
Veeva Systems introduced two new applications, Veeva Site Connect and Veeva eConsent, in October 2020, designed to facilitate seamless digital communication and data exchange between clinical research sites and sponsors, eliminating the reliance on paper-based processes.
The eConsent market is driven by several key drivers, including the increasing demand for digital solutions in healthcare.
Technology improvements have made eConsent more efficient and cost-effective by reducing the need for printing, storing, and managing paper consent forms.
National guidelines are expected to simplify the design and regulatory approval processes for eConsent implementation, further encouraging its adoption across the industry.
However, there are challenges in transitioning to eConsent, such as the need for a robust technical foundation and issues like data silos and a lack of interoperability.
North America is expected to dominate the eConsent market, driven by a rising demand for digital solutions and a strong emphasis on research and clinical trials.
Europe also plays a significant role in the eConsent market, with a substantial share attributed to the region's stringent data protection laws.
The COVID-19 pandemic has accelerated the adoption of eConsent solutions worldwide, as healthcare institutions rapidly implemented digital consent processes to enhance patient safety and streamline clinical trials.
In summary, the eConsent market is undergoing transformation due to technological advancements, regulatory support, and the increasing demand for digital solutions in healthcare.
The integration of eConsent with other clinical solutions is seen as a key driver for market expansion, as healthcare providers aim to minimize administrative burdens and improve patient understanding.
The future landscape of eConsent will be shaped by ongoing advancements in mobile technology and cloud computing, making it an essential component of modern healthcare practices.