CTRenaissance® brings holistic approach to integrated information management from design to decision and allows real-time harmonization of composite clinical trials.
The life sciences industry environment surrounded by the competitive pressures, unpredictability of outcome, and regulatory reforms, demands an increased focus on detecting leading indicators of change, and further identifying as well as quantifying impacts of newly emerging scenarios, rather than relying over black-boxed indicators of performance.
Leveraging abundance of information available from internal and external sources, industry needs a transformational strategy by making a move from retrospective modus operandi to more predictable and proactive action oriented clinical research and development model; wherein key stakeholders can proactively plan and act in time rather than analyzing the outdated information on what happened in past.
CTRenaissance® , an integrated clinical development platform, is built ground-up based on two value added information technology models - one that uses the Internet to integrate known & unknown constituents of information by externalizing the enterprise, and second that empowers you to go beyond externalization to proactively, and collaboratively explore and act on new scenarios that may impact clinical trial design strategy or operations or outcome.
CTRenaissance® Platform offers host of common services that meet with enterprise-scale, global business requirements in agile and lean manner.
CTRenaissance® offers a portal framework enabling access to one and all products through common interface and controlled web-based environment with single sign on and secured password authenticated environment.
CTRenaissance® offers a common repository services feature enabling a common persistence services to any data, document, file in the CTRenaissance® environment leveraging all other common services such metadata management, compliance management and business rules management etc., for the management of all persisted objects. Repository services also provides other standard object management features such as import, export, update, archive, backup, restore, etc.
Metadata Management Services
Metadata management service within CTRenaissance® platform provides industry standard metadata and terminology framework, further enabling the evolution of syntactic and semantic properties of every object. Metadata Management also allows setting the standard business rules that will help navigate the workflows-based execution. Metadata management under each application within CTRenaissance® platform will inherit the common functionalities like version control, review approval workflow, import/export and other common services.
Compliance Management Services
CTRenaissance suite leverages the centralized compliance management service to enable the single robust, scalable and secured tunnel for all data or document needs. It provides standard features like version control, change control, lifecycle management, complete audit tracking, provision for dependency tracking, impact analysis, and also allows retrospective analysis on any specific data or document throughout application
Data Governance Services
Data Management service enable master data management by configuring the data governance rules and data access privileges through several business rules and compliance policies including blind and unbind rules. Master data management can be configured on top any external or internal data store using our integration manager that applies the data governance rules via integration interfaces.
Business Rules Management Services
Using business rules management services, user can define as well as constrain different aspects of business processes that are intended to assert business structure or influence the behaviour of your processing. Weaving such business rule through application workflow helps gain fine grained control on application processing within CTRenaissance.
Workflow Management Services
Workflow management services enable end users to define required process flow configuration with required application services through workflow designer. Through workflow designer one can get the status and required notification on workflow status change updates. CTRenaissance® offers pre-configured workflow enabled solutions for certain industry standard processes.
Collaboration Management Services
Collaboration management service provides a platform for application users to collaborate with other team members or departmental users without the geographical boundaries. Collaboration management leverages the role management for task routing and sending notifications to appropriate roles based on pre-defined role-based workflows. This service internally uses dependency with alert and notification service to broadcast notifications to required roles.
Alert and Notification Services
CTRenaissance application utilizes alert and notification service to notify required users in real-time to notify them about any critical activities or keep them posted on downstream process updates. This common services has been utilized throughout application in other services to keep user updated in real-time.