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Clinical Data Standards Services

Dramatically Improve the quality, efficiency and the
cost-effectiveness of your clinical research processes.

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Overview

The lack of data standards for clinical trials in the Life Sciences industry has led to unstable and inconsistent processes surrounding data collection, transformation, analyses, and the ever-critical FDA submission and review process.

Compliance to CDISC standards is a detail-oriented challenge for most biopharma sponsors and CROs involving complex business processes and change management. If you plan to take standards governance to a global level, the complexities become even greater. Geographically dispersed teams managing content from numerous sources, dynamic trial data that is constantly changing, and varying health authority requirements create a scenario that begs for automation and control.

As a registered solutions provider, Platinum CDISC member, and core contributor on key CDISC committees, d-Wise has helped develop many of the current standards and implemented those standards for our customers.

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Developing Your Compliance Strategy

Assess Present State, Define Criteria for Success, Establish Plan

Before the d-Wise team can lead an effort to develop and implement data standards within your organization, we must have a complete understanding of the current state of your data standards, how this measures against the desired future state, and consequently what will constitute a successful implementation of standards for your particular organization.

This is a collaborative process, with d-Wise, stakeholders and key operational leaders working together to assess your company's standards capabilities, processes, systems and objectives. d-Wise augments this information by using decades of experience and expertise in standards and technology implementations to produce a plan for a solution that is right-sized to meet your needs and budget.

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Customers have limited experience with the requirements for module 5 of the eCTD submission and need support to ensure they have all the necessary deliverables and those deliverables are usable and compliant. They also struggle to coordinate and answer regulatory requests.

d-Wise can help you define, review, and confirm your data submission deliverables to meet regulatory expectations and provide guidance for your submission plan.

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Operationalization/Deployment

We'll map your legacy standards or existing CDISC standards to the most current standard while capturing all the metadata needed to automate upstream processes.

  • • Reduce the time it takes to convert legacy data to CDISC
  • • Receive a set of mapping templates to support your study
     team and accelerate time to delivering data
  • • Provide full set of metadata needed for regulatory submissions
  • • Increase knowledge of CDISC within their organization

workshops.pngCDISC Workshops

Delivery of interactive CDISC workshops (including CDASH, SDTM, and ADaM) which provides the knowledge of the standards, real world examples, and hands on exercises to help your organization see the practical application.

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Implementation

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Institute Governance, Enhanced Business Process and Toolset, Train and Mentor Staff

Once the project team and stakeholders have agreed to the implementation plan delivered during the assessment, d-Wise will initiate development of governance, processes, tools, metadata and custom models as needed to address plan requirements. While CDISC standards were designed with rules and best practices included, there are still significant "gray area" interpretations and Sponsor-specific decisions that must be made.

Our goal here is to define specific rules, best practices, and processes that reduce the amount of variability and avoid common pitfalls in the eventual standard, while remaining robust enough to handle typical "non-standard" business situations that may occur. More often than not, the ideal approach to standards implementations is a phased approach that initially focuses on a core set of standards that are applicable to the widest variety of activities performed by the client organization and then refined over use after implementation of a solid governance mechanism/process. Implementation is not complete without proper training to ensure that your company’s most valuable asset, your people, are fully prepared to leverage the enhanced standards, systems and processes.

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Governance

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Map Data, Generate Output, Confirm Compliance, Integrate, Analyze and Report

Whether the budget and plan require standards implementation at an early, mid, or late stage for your organization, d-Wise's CDISC experts are prepared to enhance your internal systems to produce or externally support as an extension of your company's resources the production of CDISC compliant outputs. For early-stage implementation, d-Wise provides industry proven mapping strategies that ensure your organization will be able to leverage any of your existing tools, maintain data consistency and deploy a fully integrated standards and metadata warehouse.

We provide current data warehousing, systems development and integration, and CDISC standards expertise to establish or refine your conversion processes, including standard CRF development (CDASH/SDTM), CRF annotations, dataset (SDTM, SDTM+, and ADaM) and Define.xml specifications, and the development and validation of these outputs. For late-stage implementation, d-Wise supports conversion services off of "legacy" data, as well as generation of integrated databases (ISS/ISE).

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