Services

AdClin provides value-added expertise and services in operating dossiers submission standards (e.g. CDISC® SDTM/ADaM). AdClin offers also innovative software products, engineered to streamline the processing, analysis and reporting of clinical data.

Master your clinical data | Focus on quality, CDISC compliance and SDTM/ADaM deliverables

SDTM/ADaM Packages

SDTM/ADaM Packages

AdClin provides a unique expertise for the conversion of clinical data to SDTM / ADaM standards, and offers consulting to help you matching the CDISC® and FDA’s requirements.

 
SDTM/ADaM Audits

SDTM/ADaM Audits

Conforming to Submission Standards Clinical data (application dossiers) must be submitted to the FDA using standards developed by CDISC®: SDTM and ADaM. The standards enable the FDA to control, validate and integrate submitted clinical datasets into its review and analysis system. Clinical R&D stakeholders face several challenges such as:  – integrating conversion towards SDTM/ADaM models […]

FDA OSI Site Reports

FDA OSI Site Reports

The goals of the Office of Scientific Investigations (OSI) are to verify the integrity of efficacy and safety data submitted to the FDA in support of new drug applications (NDAs) and to assure that the rights and welfare of human research subjects are protected.   This translates onto the following tasks: Auditing and verifying clinical trial […]

 
Database Standardization

Database Standardization

AdClin Clinical Study Standardization Solution™ is a highly competitive service allowing standardizing and pooling any number of studies of various formats into one consistent database.

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