We offer expert statistical programming services to support any and all clinical study reporting milestones, pre-clinical analyses and PK/PD analyses. Our staff have successfully led and supported NDA submissions, ROW submissions and set teams for success to respond to any regulatory RFIs. Our experience covers multiple therapeutic areas such as Oncology, Infectious diseases, Cardiovascular and CNS.
Our global team of statistical programmers and clinical data specialists, with an average of over 10 years industry experience, offer FSP, preferred partnerships and tailored support to your clinical studies.
Our global team of medical writers have extensive experience in development of protocols, protocol amendments, and clinical study reports. Our services include responses to regulatory agencies, preparing documents for NDA and ROW submissions.
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