State-of-the-Art CDISC-Related Services
Today, clinical data must be submitted to the FDA (USA) or PMDA (Japan) using the standards developed by CDISC®: SDTM and ADaM. The core expertise of AdClin is to process “raw” data to create SDTM & ADaM packages, perform the analyses, and deliver the CSR TFLs.
AdClin also delivers other CDISC services such as validating deliverables created by third-party CROs, converting legacy databases to CDISC standards, and training to SDTM/ADaM for both experts and beginners.
The company produces high-quality packages that allow its customers to successfully and quickly hit their key market. AdClin uses innovative and thorough processes, providing its customers a trustworthy and reliable partner.
AdClin has proven over the last 20 years the excellence of its CDISC expertise. On top of its high-quality CDISC products and services, the company guarantees the acceptance of its deliverables by the authorities. Its responsive team and its efficient approach to issues ensure a timely delivery of projects, with a controlled budget.
AdClin sets up a complete data processing chain from the raw data to the TFLs. This chain, supported by numerous tools, allows verifying in depth the consistency of input data. This can be done before the database lock, leading to cleaner data. We finally provide consistent and high-quality deliverables, with an excellent traceability SDTM-ADaM-TFLs, supported as needed by Analysis Result Metadata.
A sponsor may lack the knowledge to evaluate the quality of the SDTM/ADaM packages provided by its CRO. AdClin can review these packages from the perspective of a regulatory reviewer: the explanations for detected issues may not be acceptable, and the numerous additional checks done by AdClin may uncover issues that have been unnoticed. AdClin provides a comprehensive report of the issues found, and can assist the sponsor in obtaining from the CRO acceptable packages.
When a study has been analyzed without following the CDISC standards, and there is a risk that the authorities ask for this data during the submission, converting them to CDISC standards in advance allows controlling that risk. AdClin has a sound experience in this activity: we produce the SDTM and ADaM packages from the legacy data, and make sure that an agreed proportion of the TFL produced from this transformed data match the published CSR.
The AdClin training team is composed of seasoned engineers who convert data to CDISC standards in their daily work. They also collaborate with teams maintaining the CDISC Controlled Terminology. As a result, we offer valuable and practical knowledge to our customers, enabling them not only to understand the standards, but also to easily navigate unexpected or complex issues.