Over the coming five years, the digital transformation of clinical trials will accelerate, as the sector has largely completed its initial shift from paper-based trial processes to electronic data capture. Given the mandates for the incorporation of precision medicine, personalization and real-world evidence into discovery and human trials, as well as the integration of advanced technologies as the therapies, it is incumbent upon contract research organizations (CROs) and other key stakeholders to shift their focus to the tools and platforms of the future. A failure to recognize and respond to rapidly accelerating trends will leave organizations at a disadvantage in terms of their relevance and ability to support the next generation of clinical trials.
At CloudMine, a core element of our mission as an organization is to empower and accelerate the transition to digitally-driven clinical trials. However, many organizations do not know where to begin or where to best apply their finite resources.
The list below outlines several emerging realities tied to the evolution of clinical trials. Organizations capable of addressing these requirements will have a distinct advantage moving forward:
- Increasingly complex trial design: Addressing the potential for iterative trial design and real-time evidence gathering;
- Interoperability mandates: The call from oversight organizations to address the lack of interoperability is growing, based upon an increasing awareness of the impact upon outcomes, cost inefficiencies, and security risks;
- Precision medicine: Enabling the integration of technologies, biometric data and genomics to facilitate the delivery of individualized therapy;
- Virtual and remote clinical trials: Leveraging remote devices, passive gathering of patient-generated health data (PGHD) and social-driven trial recruitment;
- Patient-centric trials: Using bi-directional data to improve protocol design, understand patient needs during trial implementation, and translating insights into a better trial experience with application to commercialization;
- Incorporation of Big Data, AI, and Machine Learning: The potential for data aggregation across diverse populations, cohort analysis, visualization tools and insight-driven trial optimization are changing the expectations of how we leverage data from clinical trials;
- Data and device proliferation: The generation of more data through more devices will challenge clinical trial stakeholders to elevate their data governance, security assurance and translational capabilities;
- Longitudinal data and Blockchain integration: Managing and visualizing the patient journey – during clinical trials and in practice – will require the adoption of new tools, chronological (time-stamped) ledgers with advance security and privacy assurance.
The foundation for addressing these trends within the clinical trials landscape is a platform with the agility and scalability to address the near-term innovation needs of organizations, while also creating the framework to enable a future ecosystem to support evolving needs and innovation initiatives. Identifying partners who can shepherd ideas to market and co-innovate can provide additional benefit. CloudMine is prepared to help fill both of these needs by providing a platform for innovation and a dedicated customer success team to guide your way.
CloudMine’s Connected Health Cloud is uniquely designed to address the technical requirements: agile tools to facilitate the development of applications for today; an interoperability engine to integrate a variety of technologies and data flows; data visualization and governance capabilities easily integrated into existing analytics tools. Beyond these capabilities, the Connected Health Cloud provides an industry-leading, enterprise-ready security suite incorporating HIPAA, HITRUST, ISO 27001, SOC-2 and GDPR assurance, with an active security roadmap to further certifications (including 21 CFR part 11).
With use cases in clinical trials on a global scale, and recognition as a category-leading platform, the Connected Health Cloud from CloudMine is ready to enable organizations to unlock previously siloed trial data and to realize the power of interoperability in a digitally-driven future state of clinical trials.
Innovation requires partnership and a convergence of vision. Our customer success team is ready to work alongside your organization in achieving your goals, supporting you as you address the 8 realities listed above.
Don’t “go it alone,” find a partner in us! Reach out to our client success team to schedule a strategy session today.