Life-science solutions providers Cognizant and Oracle Health Sciences are collaborating with the intention of helping trial teams streamline the study startup process and foster improved collaboration. The goal of the partnership is to reduce the time required to start up studies, and get new therapies out on the market more quickly.
The companies have integrated Cognizant’s Shared Investigator Platform (SIP) a software-as-a-service (SaaS) solution, with the Oracle Health Sciences study startup applications. Outsourcing-Pharma (OSP) recently spoke with Sujay Jadhav (SJ), global vice president of product with Oracle Health Sciences, on the goals of the collaboration, the technology at the center of the partnership, and why speeding up study launches is vital.
OSP: Could you please share why Oracle Health Sciences felt it was a good idea to integrate Cognizant’s SIP, rather than use your resources to come up with an equivalent or similar solution in house?
SJ: Our combined experience of working with more than 200,000 investigative sites globally provides an opportunity to reduce study startup cycle time beyond the 30% already achieved with Oracle alone – resulting in faster time to market for new therapies. The collaboration delivers end-to-end advanced planning, predictive workflows, and document exchange capabilities, as well as access to a larger pool of investigative sites and associated data, for sponsors and CROs.
OSP: Could you elaborate on what features/functions of the SIP appealed to the Oracle team?
SJ: The opportunity to integrate the Oracle and Cognizant platforms is significant because it provides the ability for sponsors, CRO’s, and investigative sites to streamline administrative processes and increase operational efficiencies including:
- Eliminating multiple login maintenance and associated costs via secure single sign-on (SSO), which links site personnel quickly and easily to study startup technologies and tools.
- Providing a consistent and centralized experience by using site profile information that is repeatedly requested by sponsors and CROs, maintained by the site, and leveraged across multiple studies.
- Automating task generation for site users.
OSP: Why are your platform, the SIP technology and the combination of the two especially useful/important in the face of the COVID-19 pandemic, and its effects on clinical trials?
SJ: As clinical trials continue to grow in complexity, take longer to initiate, and suffer from patient under-enrollment, stakeholders have become acutely aware of the need to increase trial efficiencies and improve outcomes. The COVID-19 pandemic has exacerbated these issues. As a result, sites are stressed – they are simultaneously implementing new technologies and grappling with more stringent regulatory requirements, all while the cost and number of procedures per subject is increasing.
For even the most seasoned principal investigators, these factors can be overwhelming to manage and adds strain on site staff. Enhancing communication and collaboration with sites is vital in helping sponsors and CROs drive productivity and to keep pace with bringing new treatments to market.
Oracle with Cognizant SIP will drive operational efficiencies by harmonizing administrative processes amongst stakeholders to get studies started in the shortest amount of time possible.
OSP: Could you please list what you feel are the key benefits of the SIP-integrated system?
SJ: As a single point of access for clinical trial stakeholders, the Oracle and Cognizant solution transforms collaboration between sponsors, CROs, and sites, leading to increased site adoption and use, while reducing costs. The burden of participating in clinical trials is significantly diminished, allowing investigators to focus on patients and outcomes.
Oracle’s integration with Cognizant SIP helps sponsors/CROs to:
- Reduce study startup cycle times with analytics and dashboards that harmonize processes and common documents (e.g., form 1572, CV, financial disclosure, etc.) leveraged across studies.
- Automate workflows contacting sites and collecting site documentation for IRB/EC submissions.
- Improve communications and collaborations with investigators.
- Enhance site satisfaction with robust study startup capabilities delivered with a consistent site experience.
- Increase data reliability, transparency, and regulatory compliance with pre-configured site workflows helping ensure significantly improved study quality.
- Eliminate IT burden and ensure peace of mind that real-time integration is maintained by Oracle and Cognizant.
OSP: Is there anything you’d like to add that we didn’t touch upon above?
SJ: Oracle and Cognizant are acutely aware of the issues being faced by investigative sites, and the inefficiencies associated with study startup, both being Global Impact Partners (GIP) with the Society of Clinical Research Sites (SCRS). As recognized industry leaders, this combined offering addresses site challenges and delivers unique value in the studies’ initialization, collaboration, and management.