Clinical Data Standards

Clinical Data Standards

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Data Standards Library

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Data Migration Projects to CDISC

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Standards Mapping

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Programming Services

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Metadata Specifications

Example: Define .XML etc.
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CDISC Mapping & Output Review Services

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Creation of Macros for ADaM Dataset Creation

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Data Redaction

Clinical Data Standards

Why do we need to standardize data?

In 2013, FDA’s has released Statement on the importance of standardized study data and its positive impact on a “reviewer’s ability to more fully understand and characterize the efficacy and safety of a medical product” was made very clear. Following which towards 2014, the FDA finalized Binding Guidance documents that make submission of electronic data mandatory, and also require the data to be in a standard format that the FDA can process, review and archive.

By the end of 2016, both the FDA and PMDA will require CDISC standards for all submissions. Eventually submissions that do not comply with the CDISC requirements after the stipulated timeframe could potentially receive a Refusal to File (RTF) from the agency. Thus, all studies that start in 2017 or later will be required to submit their data to the FDA in an electronic format that uses CDISC data standards.

The Clinical Data Standards Services Offered by Clinnex include:

  • Data Standards Library
  • Data Migration Projects to CDISC
  • Standards Mapping
  • Programming Services
  • Metadata Specifications
  • CDISC Mapping & Output Review Services
  • Creation of Macros for ADaM Dataset Creation
  • Data Redaction

Our CDISC Expertise

We believe, the upfront implementation of the data standards in a sponsor’s data management and statistical environment enables sponsors to mapped data specifications to their clients and agencies in a smooth way. Clinnex has been providing its clients clinical data standardization services since inception. Our team of expert programmers understands clinical trial data generation all aspects of clinical research.

We ensure there is an accurate interpretation of the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) that is identified, documented, managed, implemented consistently, and most importantly, communicated to the Sponsor. We are well positioned to execute CDISC – SDTM & ADaM conversion projects smoothly. We deliver all this through proper quality embedded procedures which also brings in cost efficiency.

We offer highly specialised clinical research services.

Apart from our main line of services, we are open to discussion on proposals for customized services for our clients.

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