New Challenges for Clinical Data Submission
Today, clinical data must be submitted to the FDA using standards developed by CDISC®: SDTM and ADaM. These standards allow the FDA to easily integrate the received data into its review and analysis system, thus becoming for any laboratory an unavoidable prerequisite to access its target market.
Therefore, laboratories face new challenges: integrating conversion towards SDTM/ADaM models into their existing processes, while maintaining maximum productivity; avoiding possible information loss or alteration during the data transformation phase.
AdClin: A Unique Expertise in CDISC® Standards
In order to face these challenges, AdClin offers pharmaceutical laboratories a unique know-how along two major lines of action:
- A data conversion service, with the creation of SDTM/ADaM packages.
- A consultancy service, tackling current processes and CDISC® standard conformity requirements, along with a support service to define and deploy new processes, thanks to innovative methods and tailored tools.
Conversion Service to SDTM/ADaM Standards
SDTM/ADaM Package Creation
Thanks to its well known expertise and quality of service, AdClin offers high performance conversion to CDISC® formats:
Mapping to SDTM/ADaM standards, annotated CRFs, .xpt file generation from SDTM/ADaM definitions, define.xml and define.pdf file creation, validation of data and define files (OpenCDISC®, AdClin), creation of the reviewer’s guide, pooling of studies for ISS/ISE.
Knowledge to Support Strategic Projects
Thanks to ten years of experience in clinical data standardization for major players in the pharmaceutical industry, AdClin can apply its expertise to strategic projects: quickly converting significant volumes of legacy studies, or efficiently creating SDTM/ADaM submission packages (notably for pivotal studies).
Our proactivity allows us upstream identification of potential problems caused by an inadequate definition of target standards, thus guaranteeing delivery of the best possible results, and on schedule.
In addition, our pioneering methods and tools allow total control over the data transformation process, resulting in optimal traceability from the original data to their target format.
Consultancy and Support Service for the Deployment of CDISC® Standards
Are You in Compliance with the FDA’s Expectations?
How do you incorporate the activity of conversion to SDTM/ADaM models into your operations? Can these standards be easily interfaced to existing tools and methods, or will they require more extensive reorganization? At which operational stage should they be incorporated in order to respect the FDA’s current and future requirements?
Making the Best Possible Decisions
AdClin’s unique experience in the transformation of data into well-defined or adjustable models enables us to help you make the best decisions:
- By analyzing the discrepancy between your current processes and those you should put in place in the face of CDISC® and FDA requirements.
- By setting out the different solutions that will allow you to comply with these requirements first in the short term, and then in the longer term.
Deployment of Suitable Procedures and Software
Finally, AdClin can advise you on putting in place a work environment including, light, powerful and inexpensive computer tools, and innovative work procedures. Easy to deploy and user-friendly, this environment will deliver significant data processing productivity and quality gains: version control software for traceability, integration server, various tools to work faster with SAS®, etc.
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