Cytel has a strong track record in providing CDISC solutions and we are a CDISC Registered Solutions Provider. We have converted more than 150 studies as part of NDA submissions, all of which have been accepted by the FDA. The Clinical Data Interchange Standards Consortium (CDISC) devised the SDTM and ADaM models to standardize data structures for submission of raw and analysis data from clinical trials. These standard formats are increasingly expected by regulatory authorities including the FDA.
Successful studies begin with the right design. East is the industry standard for designing adequate and well-controlled clinical trials as per FDA and EMA guidance. Since its introduction in 1994, East has reliably and continuously enabled drug and medical device trial sponsors of all sizes to optimize their trial planning and monitoring efforts.
Experts in packaging patient kits and labelling.
EnForeSys is a user-friendly decision tool that leverages simulation methods to predict recruitment milestones with high accuracy. Armed with a reliable probability of success, you can rest assured that your trial will reach its targeted enrollment on time and on budget.
The knowledge we’ve gained from handling millions of international clinical supply shipments has helped us to develop an expertly managed service.
UBC helps pharmaceutical and biotech manufactures overcome access and adherence challenges by using the right combination of our high-touch services and high-tech solutions. Our patient support programs are powered by UBC Pathways™, our proprietary suite of healthcare analytics and technology solutions.
PCI offers the experience and insights of over 30 years in the storage and distribution of clinical trial materials, effectively storing and shipping thousands of patient kits to over 100 existing and emerging clinical trial countries across the world.
Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and drug interactions to unlock the potential of big data. Our team supports biomarker discovery and diagnostic test development based on biomedical signals and images, and real world evidence analysis.
Randomization and supply management is critical to any clinical trial. But traditionally, it has put a painful lag on the overall efficiency of the process. What if you could take back control and get things done in a matter of days, instead of weeks?
Flex Advantage offers enhanced randomization, clinical supply management capabilities and enables the execution of adaptive clinical trials.
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