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Thought Leadership

The strongest statistical leadership in our class

Simply put, Brightech thought leadership in biostatistics and data services sets us apart in the industry. Our 10 PhD statisticians and Innovative Trial Design Group overseen by key opinion leaders (KOPL)s positions Brightech as the only company that knows the FDA regulation, the proper statistical approach.

While other midsize Biostatistics and Data Management (BDM) CROs focus on SAS programming, Brightech helps sponsors design the efficient studies, through regulatory to the final submission package.

Brightech has

  • Been involved in over 30 NDA submissions, 6 obtained FDA/EMA approval 
  • 10 Ph.D. level statisticians with an average of more than 16 years of pharmaceutical industry experience.
  • Expertise with innovative study design (group sequential, adaptive and dynamic adaptive design), sample size estimation in design stage and re-estimation in interim stage and interim analysis
  • Extensive experience in a multitude of therapeutic areas, particularly oncology, cardiovascular disease, infectious disease, gastrointestinal disorder, CNS and analgesics; collaboration in numerous FDA/EMEA submissions
  • Expertise in complex studies. Over 80% of our studies are in oncology
  • Serve as voting member for Data Monitoring Committee (DMC) or as independent statistician to support DMC
  • Expertise with innovative study design (group sequential, adaptive and dynamic adaptive design), sample size estimation in design stage and re-estimation in interim stage and interim analysis

Brightech has completed

  • Statistics and SAS programming for 400+ phase I-IV studies
  • Data management in the US and China for 250+ phase I-III studies
  • ISS/ISE for NDA/BLA submissions (5 NDA approvals)
  • Patient profiles for 60 studies
  • SDTM, ADaM and define.pdf, define.xml for over 100 studies
  • Clinical operations in the US and China for 30+ studies
  • Protocol deviation checks via SAS programming for 45 studies
  • Medical writing (CSR, IB, ISS) for 10+ studies
  • When studies get off track using other providers, sponsors lean on Brightech; we’ve handled ___ rescue studies