Streamlining the Approval Process with the Correct Data in the Correct Format

Preparation of the clinical data and integrated summaries of safety and efficacy are pivotal components of every approval-to-market application.

Our Project Team

Cytel’s Data Submission Team consists of Statisticians, Programmers, and Medical Writers well trained in the submission standards required by regulatory authorities. Each member of the Data Submissions Team has supported numerous successful and pending NDA/BLA/MAA applications, including those in CTD format.

Our Technology

Utilizing our validated software application, MapGenie™, Cytel’s Data Submissions Team provides CDISC SDTM formatted data sets in a cost-effective and scalable solution.  Our combination of experience, global resources, and progressive technology innovations allows us to provide regulatory submission support at a cost savings of 20%-40% over most other service providers. 

When your clinical trial is ready for regulatory submission we will help you ensure your data is as well.