Metadata-driven clinical ETL tool that provides flexible SDTM data mapping, transformation and validation
A metadata management tool to encompass and consolidate myriad clinical metadata standards. Designed to improve the quality and flow of data throughout the Clinical Data Lifecycle, reduce redundancies, and increase work efficiency.
The CONFORM™ MDW allows clients to store, efficiently manage and leverage objects of various external clinical applications (e.g., EDC, ETL, TLF, etc.). The MDW includes an API that allows for bi-directional exchange of metadata between the repositories, the applications, and contributors where the sponsor determines it is appropriate. The system supports numerous EDETEK eClinical applications as well as Medidata Rave EDC.
The MDW solution provides the following capabilities:
Next-generation event-driven technology platform that provides a cloud-designed medical and business event collection for clinical systems, allowing for complete end-to end study auditing, compliance tracking, configuration of event-based applications, real-time operational and scientific aggregation and analytics.
EMS is included in all of the CONFORM™ solutions where it enables user-defined event collection, real-time integration and event-driven human and systems actions.
EMS is tightly coupled with CONFORM™ WF, in fact, workflows are all event driven.
EMS Subscription services allows for intelligently filtered actions of systems and humans that subscribe to particular events.
EMS is also an ideal platform for clinical application development and several applications are being built that EMS services and repository in their core.
Workflow is one of the foundational components of CONFORM™. It is include in all CONFORM™ solutions.
Workflow supports human, system or a combination of “human-system” processes. A combination of WF and CONFORM™ EMS creates a powerful clinical process management system.
What differentiates our system from generic BPM tools is that we have designed the system to be GxP, HIPAA and 21 CFR Part 11 compliant in its core. Additionally, WF can react to massive amount of clinical and operational events and execute complex systems and human tasks in near-real time regardless of the workload. By design, WF is integrated with CONFORM™ Platform Management so it is aware of actor’s data and functional rights. WF supports sophisticated logic of complex business processes and information flows. Numerous WF templates are installed and immediately available upon CONFORM’s implementations. Additional WF types can be configured by customers or EDETEK consultants.
Industry-first compliant clinical file-based information repository.
CDL is a multi-purpose globally distributed and accessible highly controlled repository of structured and unstructured files.
CDL carries a dual role. It provides catalogued storage for real-time automatic production of study-based analytical data sets and reports, and it also enables free-form massive informational “playground” for data scientists via CONFORM open API and several supported programming languages.
Study Metadata-driven clinical reporting tool
Study Metadata-driven analysis dataset creation
CDW is repository of patient data collected by clinical R&D.
CDW is designed to serve analytical and reporting functions of clinical and data scientists, it is also used for regulatory reporting.
The Data Warehouse is loaded with new data during the course of the clinical trial, and it maintains all versions of the data. It is a read-only database for users and external programs.
CDW is integrated into the CONFORM Informatics Premium solution that includes CONFORM™ CDL and CONFORM™ MDW. MDW stores the corporate definition of the data structures used in CDW. CDL manages study data and periodically sends data to CDW. Statistical and reporting jobs stored in CDL can consume data in CDW. Full traceability and lineage is maintained.
Functional roles and data rights of CDW users are maintained in the CONFORM™ Platform Management. PM is also responsible for assigning of the data blinding rules.
CDW is high performance, reliable and cost-effective solution that can be used by a clinical organization of any size and it can be deployed to serve data in different regions of the world.
Platform Management is responsible for making CONFORM™ applications and its users work in secure, authorized and functionally relevant environments.
In addition to typical user group and role models, PM allows for a granular control of application features to be managed by the administrators thus allowing for creation of customized roles in a particular business environment.
PM enables all CONFORM™ solutions to share a single sign on. It can manage internal or external authentication of users depending on client’s preference.
Clinical Hierarchies can be custom defined for individual divisions of the client. For example, a CRO may organize larger clients differently from smaller clients.
Information blinding, HIPAA-restricted data are also configurable within the system.
The latest features of PM support advanced and automatic deployments of our solutions in different regions of the world (even within a single client organized in multiple divisions) while configuring client’s hosting in either single-tenant or multi-tenant modes.
While CONFORM™ PM is a very sophisticated, technologically state of the art, cloud-based system internally, our engineers have designed user interfaces that are easy to understand for corporate administrators and supporting staff.
C3 is the key technological component of the CONFORM™ platform. It is a cloud-based global clinical computing environment where all CONFORM™ “for-cloud-architected” software applications and customers’ informational stores reside and function.
The design and implementation of our cloud are engineered in consultations with AWS solution architects – our multi-year development partner and cloud provider
C3 is compliant with industry regulations: HIPAA, GxP, 21 CFR Part 11. Our architects have chosen only approved components and services offered by AWS. We have added our own controls, configuration management tools and validation package to ensure and demonstrate regulatory compliance, privacy and security methods that meet or exceed typical pharmaceutical requirements
Customers can choose two different elastically scalable CONFORM™ implementations: