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  • ENGLISH
  • FRANCAIS
  • Services
    • Services Overview
    • Clinical Trial Operations
      • Protocol Development and Study Design
      • Feasibility and Study Start Up
      • Patient Recruitment
      • Project Management
      • Clinical Operations
      • Centralized Monitoring
      • Decentralized Clinical Trials (DCT)
      • Centralized eTMF
      • Medical Services
    • Regulatory and Drug Development Consulting
      • Clinical Strategy
      • Nonclinical
      • Chemistry, Manufacturing, and Controls (CMC)
      • Regulatory Affairs
      • GxP Strategy Consulting
      • Publishing and Submissions
      • Medical Writing
    • Government and Public Health Services
    • Biometrics
      • Biostatistics and Statistical Programming
      • Data Management
    • Clinical Pharmacology Modeling Simulation
      • Clinical Pharmacology Integrated Drug Development
      • Model Informed Dose & Drug Development (MIDD)
      • Pharmacometrics (PMx), Pharmacokinetics, Pharmacodynamics (PK/PD)
      • DMPK and Translational Discovery and Development
  • Therapeutic Expertise
    • Therapeutic Expertise Overview
    • By Subject
      • Oncology and Hematology
      • Rare Diseases and Orphan Drugs
      • Infectious Disease and Vaccine
      • Cell and Gene Therapy
      • Central Nervous System
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Biostatistical Consulting

  • Biostatistics and Statistical Programming
  • Biostatistics
  • Statistical Programming
  • Biostatistical Consulting

We work with your team to identify key objectives from the regulatory, corporate, and scientific perspectives. We then incorporate the objectives into powerful study designs that prioritize key goals and de-risk the development program at strategic go/no-go decision points.

Our team can assist with:

  • Study design and sample size calculations
  • Development strategy
  • Regulatory support, representation, and submissions
  • Data monitoring committee (DMC) and scientific review committees
  • Strategic product development plans
  • Individual study protocol development including novel and complex trial designs, adaptive trial design, real-world evidence and/or other external controls, natural history studies, and patient registries
  • Exploratory analyses for corporate or scientific support

 

Contact Us

Let us partner with your team on bringing new therapies to light. Get in touch to get started.

CONTACT US

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    • Oncology and Hematology
    • Rare Diseases and Orphan Drugs
    • Infectious Disease and Vaccine
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    • Central Nervous System
    • Autoimmune and Inflammation
    • Allergy and Asthma
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Cary, North Carolina 27513
+1 919-361-2286

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RG12 1QB United Kingdom
T: +44 (0) 1344 891121
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The Netherlands
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