The Technology CRO Technology Is The Difference

Cytel Services combines decades of biostatistical advancements, clinical software programming, operations know- Clinical how and deep regulatory familiarity. Technology Platform Cytel focuses on developing and deploying technology solutions that empower sponsor companies to substantially improve their clinical process e ciencies and outcomes. Software Tools CRO Services Trial Design Strategy Built upon collaborations with industry and regulators, Cytel trial Data Analysis design, analysis and data management software are relied on for their precision and proven ability to speed critical processes. Process Automation Data Management Comprehensive Clinical Operations Trial Management Programming Medical Writing

Statistics & Data Management Programming Medical Writing CDISC

• CRF development & annotation • Trial design & simulation • Protocol preparation • CRF annotation • Data management plan • FDA/EMA representation • Clinical study report writing • SDTM data set development • Database development • Sample size calculation • Submission documents • ADaM data set generation • CRF tracking • Protocol development • ISS and ISE writing • Define XML creation • Validation checks • - Adaptive & Traditional • Abstracts and manuscripts • WebSDM® compliance checking • Edit checks and query generation • Recruitment forecasting • Investigator brochures • Coding AE and medications • Event monitoring • Integrate lab data • Independent Statistical • Reconcile AE and SAE Center support See Case Studies and • Data cleaning & validation • DMC/DSMB organization Get More Information at • Lock database • Statistical Analysis Plan • Data set transfer • Statistical programming www.cytel.com Headquarters: Cambridge, MA + 1.617.661.2011

Offices: Philadelphia, PA +1.610.994.9830 San Jose, CA +1.857.928.6230 Paris, FRANCE +33.1.40.331.776 , INDIA +91.98509.70522

Cytel Clinical Research Services are trusted by drug, biologic and medical device developers worldwide. In fact, all 25 of the leading global biopharmaceuticals use Cytel technology.

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