ConformCONFORM™ Data Standardization Package (DSP)

Metadata-driven clinical ETL tool that provides flexible SDTM data mapping, transformation and validation

  • Metadata Creates and uses study-level transformation logic in CONFORM™ MDW
  • Map Development Visual source to target designer and mapping tool
  • Data Submission Creates Define XML/PDF 2.0
  • Validation FDA SDTM validation rules, EDETEK standard rules, custom logic
  • SDTM Conversion Complete SDTM coverage including submission package generation
  • Transformation Automated transformation using CONFORM™ MDW study level metadata
  • SDTM Annotations Automated production of SDTM annotated CRFs
  • Collaboration Integrated with the CONFORM™ WF engine
  • Events Management Integrated with CONFORM™ EMS
  • Data Exchange Integrated with CONFORM™ Information Hub
  • Access Integrated with CONFORM™ Platform Management for data access and functional roles
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ConformCONFORM™ Metadata Warehouse (MDW)

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:

  • Conceptual, Logical and Physical Modeling
  • Comprehensive Metadata Management
  • Object Inheritance
  • Integration with CDISC SHARE Client-Configurable Clinical Hierarchy
  • Version (and Up-Version) Management Across all Metadata Components (Structure, Semantics, Controlled Terminology, Validation, etc.)
  • Standards Change Impact Analysis Supporting Risk and Cost Assessments
  • Events Management for all Events and Actions Supporting Continuous Process Improvement
  • Comprehensive 21 CFR Part 11 Access Control
  • Change control management and workflow with included EMS and Workflow components

ConformCONFORM™ Events Management System (EMS)

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.

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ConformCONFORM™ Workflow (WF)

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.

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ConformCONFORM™ Clinical Data Lake (CDL) JUST ANNOUNCED!

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.

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ConformCONFORM™ Tables, Listings and Figures (TLF)*

Study Metadata-driven clinical reporting tool

  • Metadata – Driven by analysis metadata from Study Analysis Plan (SAP)
  • GUI Interface – Graphical design interface
  • Template Based – Standard templates for all common reporting types and layouts
  • Wizards – Analysis specific wizards to guide quick TLF development
  • Pre-build Packages – Standard packages for common reporting needs, such as PSUR, DSUR, Safety
  • TA Support – Customized TLFs for specific Therapeutic Areas analysis
  • Documentation – Automated TLF shell and programming specification creation
  • TLF Programs – Automated TLF program creation
  • Define XML - Generation of analysis results section of Define document
  • Collaboration Integrated with the CONFORM™ WF engine
  • Data Storage Integrated with CONFORM™ CDL
  • Events Management Integrated with CONFORM™ EMS
  • Data Exchange Integrated with CONFORM™ Information Hub
  • Access Integrated with CONFORM™ Platform Management for data access and functional roles
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* Available H1 2018

ConformCONFORM™ ADaM Management (ADM)*

Study Metadata-driven analysis dataset creation

  • Standard Based – Driven by industry and company standards for compliance and efficiency
  • Wizards - Analysis specific wizards to guide quick ADaM development
  • Pre-build Structure – Build-in structures for ADaM core standardization and common analysis types
  • Driven by SAP & TLF – Automated structure creation based on SAP and TLF metadata
  • TA Support – Customized ADaM structure for specific Therapeutic Areas analysis
  • Extensibility – Unlimited extensibility to incorporate existing macros and programs
  • Documentation – Automated ADaM specification creation
  • ADaM Programs – Automated ADaM program generation
  • Define XML – Automated Define XML and PDF creation, incorporating analysis results
  • Collaboration Integrated with the CONFORM™ WF engine
  • Data Storage Integrated with CONFORM™ CDL
  • Events Management Integrated with CONFORM™ EMS
  • Data Exchange Integrated with CONFORM™ Information Hub
  • Access Integrated with CONFORM™ Platform Management for data access and functional roles
Conform

* Available H1 2018

ConformCONFORM™ Clinical Data Warehouse (CDW)*

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.

Conform

* Available H1 2018

ConformCONFORM™ Platform Management (PM)

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.

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ConformCONFORM™ Compliant Clinical Cloud (C3)

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:

  • Single-tenant, where all software, files and databases reside in client’s network completely separate from other tenants of the platform.
  • Multi-tenant, an equally secure, cost-effective installation configured with shared among tenants software and physically separate storage and databases that reside in client’s network.
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