A study opportunity is presented to your organization. How quickly and confidently could you take on the study? This is the concept of research readiness. Research readiness, when put into practice, ensures that your organization can accept, activate, and adapt to new studies and opportunities no matter the regulatory circumstances, be it decentralized structure, protocol complexity, or even a global pandemic.
To be research ready, your organization must have:
- Visibility for all stakeholders into a central repository to keep regulatory processes moving
- Can your leadership team, whether on-site or remote, oversee study progress and identify bottlenecks?
- Are you able to support monitoring in-person and remotely?
- If you’re coordinating a multi-site study, do you have visibility and connection to their operations and required documents?
- Can you communicate with external stakeholders like monitors, sponsors, and IRBs quickly and compliantly?
- Systems that communicate effectively and compliantly
- If you’re working within multiple technology systems, do they minimize duplicate data entry and support more efficient routing and storage of documents and signatures?
- Is each system appropriately 21 CFR Part 11 validated or secured for its intended use, regardless of in-person or remote workflows?
- Do you have a mobile-friendly signature process for investigators?
- Easily accessible, documented, and scalable processes for research conduct
- Have you established compliant and optimized standard operating procedures (SOPs)?
- Where are your standard operating procedures stored? Are they accessible to all necessary staff?
- Up-to-date training materials and systems to recognize training completion
- How do you manage and track staff training on study procedures and processes?
- How is training certification or acknowledgment routed to required locations?
- Once trained, how quickly and accurately can tasks be delegated across your portfolio?
No other system supports research readiness like an eRegulatory Management System. An eRegulatory management system can centralize your training, documentation, processes, and communication needed to efficiently and compliantly activate a trial. In collaboration with leading academic research institutions and cancer centers, Advarra eRegulatory Management System (eReg) has evolved to comprehensively support and ensure research readiness.
This past year has displayed firsthand that the definition and expectations of research readiness can change dramatically. When COVID-19 hit, many organizations found themselves without the necessary processes and infrastructure to conduct research or accept new studies, hurting their research goals and delaying activation timelines. That’s why we’re ensuring Advarra eReg is not only research ready today, but also built for the future.
Immediate Document Access from Anywhere
Access, route, store, and centralize staff credentials, standard operating procedures (SOPs), organization documents, and past performance documents to streamline regulatory workflows from any site location.
Leverage integrations with key regulatory systems within Advarra eReg including eIRB and local IRBs, OnCore Clinical Trial Management System (CTMS), and email correspondence to increase compliance and efficiency.
Benefit from innovations by regulatory teams like yours. Utilize standardized workflows developed with community in mind including regulatory templates, digest notifications, and controlled and secured monitor access.
A Future-Proof eRegulatory System
Maintaining a research ready state requires a successful foundation for an ever-evolving industry. Advarra eRegulatory Management System is preparing for the future of clinical trials by expanding our solution to serve across the entire stakeholder spectrum, from sponsors to sites. We’re working closely with our customer community to maintain site-centricity as we expand integrations both inside and outside the Advarra ecosystem including connections with eConsent tools, OnCore CTMS documents, sponsor platforms, and more.
To explore recently released features in Advarra eReg and discuss how we’re building an eRegulatory management system that supports research readiness in the future, attend our Advarra eReg Open Demo.