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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
      • Autoimmune and Inflammation
      • Allergy and Asthma
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  1. Home
  2. Services
  3. Clinical Pharmacology Modeling Simulation
  4. Clinical Pharmacology Integrated Drug Development
  5. Clinical Study Strategy and Design
    • First-In-Human (FIH) & Single Ascending Dose (SAD) Studies
    • Food Effect Studies
    • Clinical Pharmacology Studies for Hepatic Impairment
    • Multiple Ascending Dose Studies
    • Renal Impairment Clinical Pharmacology Studies
    • Site of Absorption Studies
    • Thorough QT/QTc (TQT)

Clinical Study Strategy and Design

  • Clinical Pharmacology Integrated Drug Development
  • Clinical Study Strategy and Design
  • Development and Regulatory Strategy
  • Regulatory Representation, Writing, and Submissions
  • Scientific/Technical Writing, Manuscripts, and Communication

Our focus and expertise in clinical pharmacology and its role in drug development is our differentiator. Clinical study strategy is about much more than one study, it’s about an integrated approach to designing, conducting, analyzing, and interpreting data within the context of your overall drug development program.

The collection of relevant and high-quality clinical pharmacology study data requires both robust protocol design and experienced study oversight. Careful planning with the help of clinical pharmacologists or pharmacokineticists is crucial to make the most of the data collected. As part of any study design, your clinical pharmacology strategy should establish an understanding of existing data and how to maximize the impact of the next study on the overall plan and ultimately, the product label.

Allucent has deep experience in delivering the study rationale, design, dose(s) justification, participant population rationale (diversity), PK and/or PD sampling strategy, pharmacogenetic sampling, analysis plans, interpretation, and reporting of data for clinical trials across all phases.

Clinical Study Strategy and Design Services:

  • Clinical pharmacology development strategy
  • Study design and protocol development
  • Dose rationale and dose administration
  • PK and PD sampling schedule
  • Inclusion/exclusion criteria
  • Robust PK and PD analysis
  • Medical/Clinical monitoring
  • Biostatistics and data management
  • Clinical study report (CSR) and/or standalone PK report
  • Documents that are eCTD-publishing ready
  • Post-study update (if necessary) to clinical pharmacology strategy
  • Contribution to Pre-IND, Briefing document, IND/NDA modules’ writing
  • IB, Label and Safety update

Clinical Pharmacology Studies Supported: 

  • First-In-Human (FIH), Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD)
  • Proof of Concept and Larger Dose Ranging
  • Thorough QT/QTc (TQT), including cQT analysis
  • Relative Bioavailability and Pivotal Bioequivalence
  • Drug-Drug Interaction (DDI)
  • Food Effect
  • Large Registrational Safety and Efficacy, to establish population PK and exposure-response (PK/PD)
  • Renal Impairment and Hepatic Impairment
  • Pediatric and Elderly
  • Site of Absorption
  • Radio-Labeled Mass Balance

 

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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