It's essential to find a partner with CDISC expertise who can help meet all aspects of these critical database harmonization standards.
Theorem Clinical Research has a rich history of successful SAS® dataset conversions. Our team has vast experience providing the following stand-alone services:
- Legacy Data Conversions and Harmonizations for both SDTM and ADaM domains
- ISS/ISE Submissions
- Consultations on How to Become CDISC-Compliant including independent testing of third party vendor data and structure, as well as in-house process review
- Developing in-house training; processes, including SOPs and maps; SAS programs to both create and analyze your materials; and Metadata services and define.xml mapping techniques
Why Outsource Your CDISC Services to Theorem Clinical Research?
- Proven Performance. Since our first CDISC submission in early 2004, we've upheld a commitment to assisting clients implement these standards. In fact, we were one of the first CROs to submit a CDISC application and our Biometrics team has been designated a Registered Solutions Provider. In 2008 alone, we handled 1,629 CDISC standardized datasets—a number that continues to grow, as evidenced by our five-year experience grid.
- Focused Expertise. Our default internal standard dataset structures are CDISC driven, exposing every Biometrics team member to the related terminology and applications. Our online internal training also provides the most accurate and up-to-date CDISC information. Several team members are also active on CDISC committees.
- Global Resources. We perform all work on a centralized server located in our King of Prussia, PA office. The server is accessible from eight other global offices, enabling us to manage high volumes of data. Standardized and centralized training resources help create a worldwide network of experts, thus ensuring appropriate project staffing.