Cognizant Shared Investigator Platform (SIP)
Cognizant
Analytics and Optimization
Collaboration & Knowledge Sharing
Extensibility and Integration
The industry’s first open clinical trial operations platform across sponsors, CROs and clinical sites
Cognizant SIP is a cloud-based solution, built and developed by a consortium of leading biopharmaceutical companies that came together to share information and standardize workflows. As the industry’s premier clinical trials operations platform, Cognizant SIP provides a single point of access for clinical trial stakeholders, transforming how sponsors and sites collaborate. Site selection, communications and management are all hosted on a secure platform tailored for the needs of sites and investigators.
Description
Cognizant® Shared Investigator Platform (SIP) is the industry’s first cloud-based single-instance multi-tenant solution that offers broad capabilities across the lifecycle of a clinical trial from site selection and study execution all the way to study closeout.
Developed in close partnership with trial sponsors and research sites, Cognizant SIP unites investigators and sponsors and allows them to work together virtually, anytime, anywhere. Providing a single point of access and a central workspace, the platform accelerates key clinical trial processes and reduces the administrative burden on investigators, which helps enable faster time to market for new therapies and more time for patient care.
Through its single sign-on capability, Cognizant SIP reduces the need to log into multiple portals or applications and brings together best-of-breed technologies from an ecosystem of partners to streamline collaboration for trial sponsors, CROs, site investigators, and clinical researchers.
Cognizant SIP helps sponsors accurately report safety notifications as per local regulations by setting up automated global and country distribution rules. The platform helps sponsors reduce redundant training for sites by recognizing over 1,900 Mutually-Recognized Training (MRT) courses that have been completed by sites.
Developed in close partnership with trial sponsors and research sites, Cognizant SIP unites investigators and sponsors and allows them to work together virtually, anytime, anywhere. Providing a single point of access and a central workspace, the platform accelerates key clinical trial processes and reduces the administrative burden on investigators, which helps enable faster time to market for new therapies and more time for patient care.
Through its single sign-on capability, Cognizant SIP reduces the need to log into multiple portals or applications and brings together best-of-breed technologies from an ecosystem of partners to streamline collaboration for trial sponsors, CROs, site investigators, and clinical researchers.
Cognizant SIP helps sponsors accurately report safety notifications as per local regulations by setting up automated global and country distribution rules. The platform helps sponsors reduce redundant training for sites by recognizing over 1,900 Mutually-Recognized Training (MRT) courses that have been completed by sites.
Content Hub Advantage –
Content Planning,
and Launch in 10 Weeks
EPAM’s Content Hub Advantage allows customers to quickly stand-up, configure, and launch Content Hub.
Features of the Cognizant Shared Investigator Platform:
Tasks and Delegation
Consolidates news, links and tasks across sponsors and studies
User Profile
Includes sponsor searchable electronically-signed “Digital CV.”
Facility/Department Profile
Describes the capabilities of each clinical location at which patients are treated.
Organization Profile
Enables sites to proactively delegate SIP maintenance to the site support organizations with whom they work, streamlining study startup.
Study Workspace
Gives sites access to all of their SIP studies across sponsors in a single location and eliminates data entry by enabling reuse of site details across studies.
Survey
Facilitates response to feasibility and study surveys across all sponsors.
Training
Reduces redundant training by securing credit through MRT, and tracks study training completion in one location.
Document Exchange
Enables collaboration, exchange and electronic signing study documents, and streamlines study startup with document packages.
Safety Exchange
Leverages a single inbox across all SIP locations, reducing the time needed to review and acknowledge safety letters.
SIP Connect
Connects sites’ eReg binders to SIP to seamlessly manage and share study documents from the eReg binder with sponsors via SIP
Sponsor benefits - with Cognizant SIP, sponsor organizations are able to:
- Accelerate site activation - Search for sites, investigators and facilities based on your protocol requirements. Access site and facility profiles that are up to date and comprehensive.
- Create virtual workspaces - Collaborate with your sites by securely exchanging documents and information.
- Enable remote collaboration with investigators - Cognizant SIP enables clinical research associates (CRAs) to collaborate virtually with investigators and site staff, saving travel costs and limiting COVID-19 risk.
- Maintain study oversight - Site leaders gain a clear view of staff workloads so they can allocate resources effectively, as well as proactively identify and address risks and issues.
- Track trial progress - Dashboards and reports track trial progress, including milestones, safety information and interim analyses. CRAs can electronically request access to investigators’ eRegulatory binder systems, reducing paperwork and manual data reviews.
- Improve investigator experience - Cognizant SIP leverages common workflows across sponsors, eliminating the need to learn different processes for different sponsors, alleviating much of the administrative burden of running clinical trials for multiple sponsors.
- Keep communications accurate and current - With its up-to-date roster of study and site contacts, Cognizant SIP ensures communications are routed to the correct sponsor and site personnel. Sponsors can create rules that ensure any site staff changes trigger applicable onboarding tasks, such as training and document completion.
- Automate documentation - Cognizant SIP makes it convenient to create, access and exchange documents. It automatically generates many site documents from site and investigator profiles already in the platform. Sponsors can easily access documents, such as electronically-signed CVs and Form 1572s. Investigators and other clinical stakeholders can review and acknowledge safety notifications across multiple studies.
- Access virtual training course - Cognizant SIP’s training module includes protocol-specific and other study-related offerings. Through the learning management system, sponsors recognize over 1,900 Mutually-Recognized Training (MRT) courses that sites can complete, reducing redundant training for sites. Training records are stored in a single location, enabling sponsors and sites to track them, avoid duplicate trainings and facilitate proper compliance and credit.
Site benefits - with Cognizant SIP, sites are able to:
- Create a single sign-on - Sites can access all of their clinical trials across participating sponsors in one place.
- Build a user profile - Enter data once and maintain credentials centrally for platform sponsors and studies. Includes sponsor-searchable, electronically-signed digital CVs for investigators.
- Manage facility and department profiles - Sites need only to complete their profiles and upload once for them to be accessible to platform sponsors and their future studies. User profiles can also be associated with multiple facilities and departments.
- Work digitally - Sites, facilities and investigators are interconnected, enabling all to complete feasibility surveys and manage startup and day-to-day tasks for clinical studies.
- Participate in dedicated study workspaces - Each study has its own designated work area where sponsors and study teams can post, share and retrieve documents safely and securely.
- Prioritize and manage work - Investigators have a consolidated view of tasks across studies and sponsors.
- Access and acknowledge receipt of safety notification reports - Sites have access to a centralized dashboard view of their clinical trial safety reports.
- Track training - Investigators can complete training courses for one sponsor and receive credit across all participating sponsors via mutually-recognized GCP training.
- Facilitate and maintain site regulatory binders - Cognizant SIP streamlines access to eISF, which enables clinical trial sites to electronically manage their essential regulatory study documents and data. This capability also enables both sites and sponsors to seamlessly exchange documents and information.
Company Profile
Cognizant is one of the world's leading professional services companies that engineers modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast changing world. Together, we're improving everyday life.
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https://www.cognizant.com
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Cognizant Shared Investigator Platform (SIP)