Our validation approach goes beyond standard checks, offering a more in-depth and contextual analysis of the packages. We not only examine technical compliance but also assess the quality and clarity of the information provided to facilitate the review by regulatory authorities (FDA, PMDA).

SDTM review

A review of an SDTM package allows for the validation of the following points :

  • Correct use of SDTM variables and domains in accordance with various CDISC recommendations and, where applicable, regulatory authorities, study design, and the study CRF ;
  • Correct use of controlled terminology (CT) by domain, variable, and parameter ;
  • Proper and valid key usage to best understand the structure of a domain ;
  • Consistency of each documentation element (csdrg, acrf, define.xml) ;
  • Consistency between documentation and data ;
  • P21 messages are inevitable, and the provided explanations are understandable and correct.

ADaM review

Our strong expertise allows us to validate the compliance of an ADaM package, which must :

  • Adhere to the CDISC ADaM standard ;
  • Be easily understandable by the regulatory reviewer (with sufficient explanations) ;
  • Have documentation (define.xml and adrg) that is consistent with the data ;
  • Have properly detailed derivations of ADaM variables and datasets ;
  • Not contain P21 messages, except in exceptional cases, in which case the provided explanations must be understandable and correct.

Implementation

Different types of reviews are offered :

  • High-level review :
    • Assessment of the overall consistency of the package,
    • Superficial assessment of the datasets.
  • Complete review :
    • High-level review,
    • Detailed assessment of each dataset.

A report is provided to the sponsor, listing any non-compliance issues detected along with recommendations for each. We then discuss the findings with the sponsor to help them assess the risk for each point in the report:

  • Likely to "pass" as is ;
  • Will likely be a dealbreaker.

The review of a package can be done once it is final or periodically with incomplete packages during the study.