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• Late Phase and ePRO Solutions
• CDISC Standards

CDISC Standards

Support for CDISC standards is emerging as a critical requirement for organizations that collect and manage clinical research data. Sponsors who recognize the importance and benefits of adopting standards will most likely want to choose clinical technology vendors who support these standards. In the case of CDISC standards, sponsors will want to understand their vendor’s position in some of the following areas:

• Support for the CDISC SDTM in data libraries, data repositories and database extracts. The SDTM defines standard record structures and variable names for many kinds of clinical data collected in clinical trials. Since the SDTM was designed as a submission rather than collection standard, it does not always directly accommodate all of the various questions that may appear on a CRF, but it will provide a standard mechanism for representing all of the essential information collected. Use of SDTM standard variable names, structures and terminology will improve the sponsor’s ability to use standard analytical and reporting tools, to load data into a standards-based data warehouse or repository, to exchange and integrate data among partners and vendors, and to efficiently prepare data for regulatory submission. CDM vendor products should include standard SDTM libraries, and be amenable to reporting data structured in SDTM format. Phase Forward’s Lincoln Products Group has created and converted about 200 clinical trials to CDISC SDTM.
• CDISC ODM import and export support. The CDISC Operational Data Model (ODM) is a standard XML schema for representing the metadata, data and audit trail for a clinical study. Because ODM conforms to a fixed schema, it ensures consistency in how this metadata and data is represented and can be validated by XML applications. Because XML consists of tagged text, it can be read and written by virtually any computer system and is ideally suited for the creation of standard import or export applications. CDM vendor products should support the export of ODM study data or archive files, and as much as possible, the import of study metadata (and data) in ODM format. Phase Forward is fully certified in CDISC ODM import and export capabilities.
• Loading laboratory data in CDISC LAB model format. The CDISC LAB model was designed as a standard for transmitting lab data from a central lab to a sponsor operational database. The LAB model accommodates virtually any kind of central lab data by using standard variable names and attributes (similar to – and harmonized with – the SDTM) but also includes additional transmission, administrative and referential information that facilitates complete and quality transfers without requiring creation of custom interfaces for each lab. CDM vendor products should be able to import and integrate data in this format. Phase Forward can load laboratory data in the CDISC lab model format for existing customers.
• CDASH: Streamlining data collection to support trial interoperability.The Clinical Data Acquisition Standards Harmonization (CDASH) standard, supported by CDISC, sets a framework for collecting data in clinical trials based on predefined standardized rules. Its goal is to improve the speed and methodology in which data is collected though out the planning, collection, management, and analytic lifecycle of a clinical trial. To achieve this goal, consensus-based content standards have been established to be adopted on a global scale by organizations such as clinical investigators, clinical research associates or monitors, biostatisticians, eCRF designers and clinical trial data management vendors. Phase Forward’s Central Designer supports CDASH-standardized forms and offers free access to its CDASH library.
• Support for the SDTM and Structured Protocol Trial Design Model. The CDISC Trial Design Model was developed by members of the CDISC SDS and Structured Protocol Representation teams to represent the overall design of a study by defining the treatment groups, visit schedules, data collection plans and treatment plans. Use of this model will make it possible to perform advanced analyses that can better adjust to the anomalies of individual protocol designs when accessing data warehouses (such as the FDA’s Janus data warehouse), and ensure a consistent representation and interpretation of protocol designs when exchanging trial setup metadata between systems. CDM vendors should employ trial design concepts in their study design tools, and allow import and export of trial design information represented in ODM and SDTM format. Phase Forward fully supports the STDTM format. In fact, the FDA uses Phase Forward’s Web SDTM solution to check SDTM format compliance prior to submission.
• Support for E2B transfers of safety data. Among Pharmacovigilance (PV) systems, the ICH E2B XML standard offers a standard representation for exchanging information about adverse events between systems. PV system vendors should support data import and export of adverse event reports in E2B format both to support regulatory reporting requirements and to facilitate data integration for analysis and mining purposes.
• Open connectors and APIs for data exchange and extensibility. Since many activities are underway to enhance existing standards and develop new ones in other critical areas, it is essential for vendor products to have an open architecture that can be easily adapted in the future to accommodate new or revised standards without requiring significant changes in the underlying system architecture. Phase Forward can provide standardized APIs through its Adapter solution.
• Active participation in standards development activities. While it is entirely possible to adopt published standards without direct involvement, vendors who have made an active commitment to the standards effort are likely to be more knowledgeable, experienced, compliant and committed to a standards-based strategy than those who are not. Phase Forward is an active member of many standards-based organizations, such as HL7 and CDASH.

Phase Forward’s Lincoln Technologies safety experts have been active in the CDISC standards development activity since its very beginning, making a major commitment to providing support for CDISC standards throughout our product and services offerings. CDISC-based products include the FDA-standard review tool WebSDM, for review, checking and preparation of electronic submissions, and the Empirica Study product, a signal detection solution that uses the SDTM standard as its platform. CDISC services include implementation and strategy consulting, training and data conversion.

Our strategic approach to data standards has blended leadership with pragmatism to meet high-priority customer needs, resulting in a wide range of products and services that support those standards that are likely to have the greatest benefits for our customers.