Clinical Data Standardization

Standardizing the content and structure of the data in clinical trials is vital for achieving the dramatic quality, cost and duration improvements that are being demanded of the industry. Any viable solution must support the needs of sponsors, CROs and other vendors, regardless of whether data processes are kept in-house or contracted out.  Within the next year, the FDA will issue a rule requiring all NDA- and BLA-related submissions to be in CDISC SDTM format, making this a perfect time for organizations to align with the emerging standards.     

Kestrel offers a comprehensive suite of services and products to help with your organization’s standards requirements, including:

• Assessing the CDASH-compatibility of your company’s current standards and recommending strategies and tactics for migrating to CDASH complianceDeveloping new CDASH- and SDTM-compliant standards
• CDASH orientation and training
• Defining and implementing standards-based quality systems for clinical data
• Int.egrating data capture standards into programming, statistics, CSRs, protocols and monitoring guidelines.
• Defining and documenting processes and SOPs and associated training
• Data Lifecycle Plans^®

• Expertise.  Kestrel is a CDISC Registered Service Provider for CDASH.
• CDASH Development.  Kestrel’s Kit Howard participated in the development of CDASH, and currently serves on its management board.  She has a comprehensive understanding of the CDASH model, and particularly of the different ways the domains can be interpreted. 
• Inside knowledge. CDASH has published the core standard, but much remains undocumented, including robust definitions and rationale for excluded fields, a comprehensive mapping to SDTM, and the rationale for many of the recommended data structures.  Kestrel is familiar with these and will help your organization streamline the design and implementation of a compliant standards strategy.
• Head start.  Kestrel has mapped CDASH to SDTM, and has developed integrated structures linking CDASH definitions to the rest of the clinical research process.  This can greatly speed the assessment and implementation of CDASH.
• Extra resources.  Kestrel has the expertise and the resources to devote to the project, minimizing the downtime for the organization’s staff and enabling them to remain focused on the organization’s core business.
• End to end integration.  Kestrel’s Data Lifecycle Plans® demonstrate our core understanding of the data’s relationships from capture through reporting and submission, and we can help organizations implement right the first time.
• Strategy and tactics.  Implementing new standards and updating existing ones require different strategies and different tactics.  Kestrel has extensive experience in different approaches and can help organizations choose the best one for their situation.

Data Lifecycle Plan^®

Kestrel believes that the foundation of quality is an understanding of intended uses of the data coupled with transparency between the clinical development team members. When each participant understands the requirements and deliverables of each functional area, the chances of data mishandling and misuse drops dramatically. When documented properly, these definitions can be reused, resulting in time and cost reductions. This is the foundation of the Data Lifecycle Plan^®.

A Data Lifecycle Plan^® is a centrally accessible, study-independent, software-independent document that defines in non-technical language the data structures and associated processes from protocol definition through clinical study reports for a given data domain. 

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There is one DLP for each data domain, and each consists of a number of sections, each of which defines the requirements of a functional area.

Kestrel offers a range of solutions based on DLPs:

1. Data Lifecycle Plan^® Methodologies: At their core, DLPs represent a method of defining each clinical trial stakeholder’s requirements for data and the relationships and processes between those stakeholders. The DLP Methodologies Package includes DLP templates and process descriptions and guidelines enabling an organization to develop new or leverage existing company standards content.

2. Data Lifecycle Plan^® Core Contents: For organizations that do not already have their own data definitions, Kestrel provides a core set of DLPs that have been populated with the most commonly used data domains, such as Demography, Adverse Events and Vital Signs. Organizations that already have some DLP section content can start with their existing materials and draw the remainder from the Core Contents DLPs. In either case, the organization can customize the DLPs to comply with its practices.

3. Efficacy DLP Library: to take full advantage of the DLP approach, all data in studies should be defined in DLPs. Kestrel has an expanding library of DLPs for efficacy and other parameters. Examples include the Hamilton Depression Scale and the SF-36 Quality of Life scale.

4. Customization and Implementation: Kestrel offers consulting expertise to assist in customizing, developing and implementing DLPs and defining the processes to optimize them for each client.

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To see a variety of DLP implementation scenarios please click here.

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