CRO Services

A full-service CRO that delivers to your expectations

Advanced Clinical

Biostatistics

Advanced Clinical provides comprehensive, quality-driven Biostatistics and SAS Programming services. With our expertise, clients are able to make decisions quickly and reduce the time to NDA submission and marketing approval.

Biostatistics Services

  • Statistical Analysis Plans
  • Protocol, Case Report Form, and Clinical Study Report review
  • Randomization schedules
  • Planning and implementing Interim Analyses
  • DSMB/DMC and Clinical Events Committee support
  • NDA: Integrated Summary of Safety/Integrated Summary of Efficacy (ISS/ISE)
  • FDA and other regulatory interactions, including Advisory Committee meetings
  • Publication support and ad hoc Analyses
  • Statistical Consulting

SAS Programming Services

  • Experience with multiple EDC platforms
  • CDISC implementation (SDTM and ADaM, Define.xml, annotated CRF)
  • Derived dataset production and validation
  • TLF production and validation
  • Development of integrated ADaM datasets for ISS/ISE analyses
  • Submission-ready datasets and programs
  • Study rescue and legacy data requests

Advanced Clinical approaches biostatistics and SAS programming with a team-oriented approach. We collaborate with our clients to increase the probability of success. Our recommendations are based on over 20 years of experience in clinical trials. Our team works closely with and coordinates with other functional areas and vendors to increase quality, shorten timelines, and improve deliverables.

Advanced Clinical’s Biometrics team has provided services for hundreds of studies across all major therapeutic areas, and has submitted 6 NDA filings in the past four years. Advanced Clinical is a long-time member of CDISC, and our Director, Biostatistics is a member of the CDISC Questionnaire sub-team. Our Biostatisticians are members of Drug Information Association and American Statistical Association, and all of our SAS Programmers are SAS 9 certified. Our Director, Biostatics has 20 years of pharmaceutical experience with 25+ years of statistical consulting and has published over 60 articles in multiple therapeutics areas.

847-267-1176