By Neil de Crescenzo
Clinical development is now entering an era of virtualized research that has the potential to accelerate and bring new levels of cost-efficiency to the drug development and trial process. Health sciences organizations increasingly partner with and rely on a myriad of ad hoc partners from around the globe — spanning academic research centers, private research and development organizations, CROs, public sector agencies, and healthcare organizations — for R&D, as well as clinical trial operations.
Today, the challenge for many health sciences organizations is finding a way to efficiently manage these virtual environments, which are complex since they are increasingly characterized by:
a sequential approach to processes and trials as well as compartmentalized stakeholders
multiple systems/vendors with high integration overhead as integrations are being managed for each initiative/trial
manual data integration from third-party sources
a lack of traceability and control
A new generation of best practices and tools can help organizations seamlessly connect with partners and identify and capitalize on pre-existing synergies to realize the full potential of virtualization. These include:
Stick with the standards. An IT infrastructure that supports a virtualized environment must be able to handle the many diverse forms of data that will flow into it from internal as well as external sources. Health sciences organizations and their systems must be able to accept, normalize, and act on this data. As such, standards-based systems are essential. By leveraging external industry data standards, such as CDISC (Clinical Data Interchange Standards Consortium), ICH (International Conference on Harmonization), and HL7 (health level 7), health sciences organizations can greatly simplify the exchange of data between large numbers of diverse partners.
Respect privacy and security concerns. Organizations should ensure that the technology and services they utilize are both CFR Part 11 compliant and HIPAA-certified in order to respect privacy and data protection restrictions.
Identify appropriate data storage resources up front. In a virtualized environment, data volume increases exponentially. Organizations require a robust clinical data warehouse that can centrally aggregate all trial and third-party data for analysis.
Build it once, use it often. Virtualized clinical development environments offer the ability to leverage important data gleaned from an external source throughout the enterprise. An environment with multiple, “stove-piped” systems maintained for separate trials or individual integrations for separate initiatives limits this potential. It also adds unnecessary costs due to multiple and often duplicate integrations. By shifting to a unified, enterprise-wide approach to infrastructure and applications, organizations can facilitate transparency and increase insight, reduce IT management costs, and ease the integration burden as it is “once and done.”
Focus on enabling seamless workflows across all key systems — eClinical, safety, clinical data warehousing, and operational planning, tracking, and management. Automated workflow between these core functions will bring new levels of operational efficiency and improve traceability and control. For example, automated workflow can enable seamless data capture, randomization, supplies management, and in-stream coding; streamline adverse events reporting and ongoing pharmacovigilance initiatives; and enable improved data flow. One-off integrations between technology providers can add additional complexity.
Help users direct their focus where it’s needed and most productive. Understand there is a growing universe of system users, and ensure your systems are process- and people-centered, versus application focused. It’s vital to minimize the complexity of today’s clinical development technology to achieve meaningful efficiencies and streamline workflows across technologies, partners, and trials.
A virtualized clinical development environment offers exciting opportunities to advance discovery and contain costs. Organizations embarking on this exciting transformation first need to carefully consider their supporting IT infrastructure. Avoiding complexity by focusing on a standards-based, integrated, and enterprise-wide approach that aligns with organizational data structure and requirements is instrumental in unlocking the full potential of this new approach to clinical development.
Neil de Crescenzo is the senior VP and general manager for Oracle Health Sciences, where he supports Oracle’s business unit dedicated to producing integrated end-to-end solutions that help health sciences organizations deliver quality products.