Resources

Brochure

Leveraging PK and PD Modeling in Drug Development to Improve Care for Children

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Article

A Journey of Collaboration and Future Transformations in Biotech Space

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Article

Patient-Centric Approach To Accelerating Clinical Trials

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Webinar

More than Skin Deep: Considerations for Dermatology and Drugs Administered to the Skin

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Webinar

PBPK Modeling for Pediatric Drug Development

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Inroads To Approval: Navigating Formal FDA Meetings to Optimize Your Drug Development Program

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Exosomes:  Unveiling Their Potential in Cell and Gene Therapy 

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Brochure

Technical Writing Services with a Clinical Pharmacology Focus

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Brochure

Study Design and Conduct Leveraging Allucent's Clinical Pharmacology Expertise

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Population Modeling Capabilities

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Model-Informed Drug Development

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Begin with the End in Mind Investigational New Drug (IND) Services

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Allucent's Expertise in Predicting Human Exposure From Nonclinical Data

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505(b)(2) Regulatory Pathway - Clinical Pharmacology Services

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Case Study

Using PBPK to Optimize Magnesium Concentrations in an Intravenous Formulation

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Case Study

Using PBPK to Extrapolate Animal Tissue Concentrations to Humans

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Case Study

Using Modeling and Simulation to Determine FIH Dose

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Case Study

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Case Study

Due Diligence to Support a Client’s Decision-Making

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Case Study

Complex Concentration-QT Analysis

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Article

Rare Central Nervous System Disease Trials

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Blog

Series on Cannabis and Cannabis-Derived Products for Therapeutic Development, Part One

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The Office of Therapeutic Products (OTP): A New Way Forward for Cell and Gene Therapies

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Nonhuman Primates (NHPs): FDA Issues Guidance for Use in Nonclinical Safety Studies

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Stepwise Paediatric Investigation Plan — Evolutionary or Revolutionary?

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FDA Clarifies Policy on Post-COVID Meetings

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Let's Extrapolate!

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Article

Guide to CTIS Workspace Organization

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Overcoming Patient Recruitment Difficulties in Acute Ischemic Stroke Trials

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Guide

Biometrics Fact Sheet

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Lessons Learned as Early Adapters of the EU’s Clinical Trials Regulation

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Diversity in clinical trials: Optimizing drug development strategy, leveraging data and increasing efficiency with modeling and simulation.

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How to Overcome Challenges in Combination Immunotherapy Clinical Trials

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Guide

When should you incorporate CPMS?

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Podcast

Operationalizing Cell and Gene Therapy Trials

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Podcast

Why Multinational Clinical Trials are Key to Bringing Novel Therapies to Patients

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Podcast

Defining the Regulatory Roadmap for Product Success

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Article

Spotlight on oncology drug development and its future

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Article

Focusing on smaller biotechs to have a big impact on society

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Article

Big passion for small biotech and its potential to address complex diseases

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Article

When it comes to small populations, biotechs need to think big

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Guide

What's Up: 5 Areas Where a Biostatistician Can Help

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Guide

A Guide to Scientific Advice

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White Paper

Citeline Report - Executing Early Phase Research In Hematological Oncology: What Matters To Biotech?

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Developing CNS Neurotherapeutics with Cerebrospinal PK/PD Clinical Studies

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Accelerating Drug Development of Innovative Oncologic Agents: Master Protocols

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Long-Term Follow-Up for CGT Trials: Best Practices to Operationalize

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What is Pharmacodynamics?

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The Role of Statisticians in Study Design and Why to Engage them Early

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Webinar

Benefits of Bayesian Dose Escalation Designs for Oncology Studies

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Webinar

Risk Assessment: Traditional and Novel Approaches to Assess and Manage Risks

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Guide

A Snapshot of Gap Analysis

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Risk Assessment: Traditional and Novel Approaches

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The Role of Clinical Pharmacology in New Drug Development

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Gap Analysis: The Benefit of Conducting Technical and Regulatory Due Diligence

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Article

Allucent Scientists Author Top Downloaded Journal Article in Clinical Pharmacology & Therapeutics in 2021

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Guide

3 Tips for IMPD Success

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What is Clinical Pharmacology?

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Smarter Drug Development for Rare Diseases

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Case Study

Grass & Birch Allergy Phase II Parallel Studies

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Case Study

Grass & Birch Allergy Phase II Parallel Studies

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The Essential Role of the CMC Expert

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Rare Disease Research – Why We Do What We Do

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A Regulatory Perspective on Cell and Gene Therapy in Oncology

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Webinar

Inspection Readiness: What is it, why it matters, and what you need to know to be prepared

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Inspection-Readiness: What You Need to Know to Prepare for a GCP Inspection

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Leveraging Modeling & Simulation for Pediatric Drug Development

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Developing Oligonucleotide Therapies

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What is Pharmacokinetics and ADME?

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Optimizing Trial Efficiency with Bayesian Dose Escalation Designs

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Understanding How PK Data and CDISC Work Together

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The Potential of Biosimilars – for Drug Makers and Patients

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The Multifaceted Role of the Nonclinical Expert at the Center of Drug Development Teams

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The Black Box of Anti-COVID-19 Monoclonal Antibodies: An Overview, Definitions, and Terminology

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Expediting Treatments to Oncology Patients in Need: Understanding the FDA’s Accelerated Pathways

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Common Clinical Pharmacology Mistakes to Avoid in Drug Development

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Compartmental Modeling in Pharmacokinetics

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Webinar

Navigating Regulatory Strategies for Cellular & Gene Therapies

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Determining First-in-Human (FIH) Dose for Clinical Studies

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Introduction to Healthcare-Associated Infections (HAIs)

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How to Use Modeling and Simulation to Optimize a 505(b)(2) Application

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Benefits of Using Modeling and Simulation to Design and Interpret Phase 3 Clinical Trials

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FDA Project Optimus: Selecting the Optimal Dose for Oncology Therapeutics

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The Case for Early Regulatory Consideration for Clinical Development of Chimeric Antigen Receptor T cell (CART)

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How to Form a Clinical Pharmacology Strategy for your NDA, BLA, or MAA

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Great News from EMA in December: Three New Treatments for COVID-19

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Article

Long-Standing Partnerships: Immutep's CEO, Marc Voigt in an interview for CEO Magazine

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Cervical Health Awareness Month - Cervical Cancer: Prevention, Detection, Development

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Pharmacokinetic Parameters in Drug Development

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Blog

Adaptive Design Considerations for Early Phase Oncology Trials

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Case Study

Indolent NHL Immuno-Oncology Rescue Study

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Blog

Respiratory Viral Infections: Progress and Innovation

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Understanding Long-Haul COVID

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The Role of Liquid Biopsies in the Clinical Trial Setting

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What are Good Laboratory Practices (GLP) for Nonclinical Studies?

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Benefits of Utilizing the 505(b)(2) Pathway for Prodrugs

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Understanding CDISC SEND Data and How to Be Compliant

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Blog

Important Milestones in Infectious Diseases Clinical Trials: A Timeline of Infectious Disease Research

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Infectious Disease Research: Importance of Site Location in Clinical Trials

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Blog

EU Clinical Trial Regulation: What, When, Who, Why, How?

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Blog

Leveraging Autoimmune Therapies in Infectious Disease and Vaccine Research

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Pre-IND Meeting Guide: Benefits & How to Prepare

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Autoimmune Clinical Trials: A Brief Review of Recent Autoimmune Research

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Important Milestones in Autoimmune Research: A Timeline of Autoimmunity

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Better Clinical Trials: How Does Location Impact Autoimmune Research Studies?

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Blog

When Should You Hire a Clinical Pharmacologist?

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Autoimmune Research in Review: Microbiome, Microbiota, and Immune System Conditions

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Webinar

Roadmap To Marketing Authorisation in Europe: Taking All the Right Turns

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Blog

What Is CDISC and What Are CDISC Data Standards?

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Allergy Clinical Trials: Recent Asthma and Allergy Research in Review

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Blog

FDA Orphan Drug Designation for Rare Diseases

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Important Milestones in Allergy Research and Clinical Trials: A Timeline

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Blog

Site Location Selection: Key to Conducting Better Allergy Clinical Trials

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Blog

Allergy Immunotherapy in Review: New Developments in Immune Therapy

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Blog

Common Misconceptions About PBPK Modeling

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White Paper

Mind the Gap: The Importance of Gap Analysis in Securing Regulatory Approval

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Blog

Cancer Clinical Trials: Recent Oncology Research Studies in Review

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Blog

Anticipating Obstacles to Approval Before Your Early Phase Oncology Study: Four Critical Areas to Consider

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Blog

How to Choose Sites for Cancer Trials: Central and Eastern Europe

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Blog

CAR T-Cell Therapy Challenges to Development & Approval

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Blog

Clinical Trials Today: Recent Milestones in Rare Cancer Research

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Blog

What is a 505(b)(2)?

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Conducting Clinical Trials in Rare Oncology

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Blog

Rare Disease Research in Central and Eastern Europe

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Blog

Understanding the Importance of Location in Rare Disease Studies

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Presentation

Managing Clinical Trial Risk Strategically: Collaborating for Success With Your Outsourcing Partners

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Blog

Impact of COVID-19 on Rare Disease Research

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Blog

Common Misconceptions About QSP Modeling

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Blog

Challenges to Research in the Age of COVID

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Blog

Cost-Effective Techniques for Creating QSP Models

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When Will Patients Return? The COVID Impact

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Blog

EMA & FDA Approvals and Recommendations in 2020 for Oncology Drugs and Diagnostics/Devices

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Blog

What’s Happening in Ulcerative Colitis Trials Right Now?

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Blog

Understanding Current and Future Therapeutic Options for COVID-19

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Blog

8 Strategies for Navigating Clinical Studies During COVID-19

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Blog

6 Tools Used To Achieve a Clean & Reliable Database Lock

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Blog

What is Earned Value Management and Why Use It at a CRO?

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Webinar

Webinar | Pharmacogenomics and Pediatric Drug Development: When Are Children Not Little Adults and Why?

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Blog

Fostering Inclusion and Diversity in Clinical Trials

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Blog

Risk Management: Your Foundation for Better Project Management

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Blog

Clinical Highlights from the First Virtual European Society for Medical Oncology Congress

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Blog

Strategizing for NDA/BLA Series Part 2: Planning Ahead for Your NDA or BLA

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Blog

What is the Difference Between Microbiome and Microbiota?

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Blog

Understanding the Connection Between COVID-19 and VAP

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Blog

Current and Emerging Therapies for Patients With Multiple Myeloma

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Blog

The Role of Pre-Clinical Pharmacokinetics in Early Drug Development

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Webinar

Next Generation Strategies for Orphan Drug Development

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Blog

Improving Informed Consent in Clinical Trials

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Blog

Understanding the 3 Types of Clinical Trial Monitoring

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Blog

New FDA Guidance for October 2020 and Upcoming Advisory Committee Meetings

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White Paper

Current Trends in the Clinical Development of Combination Therapies with Immune Checkpoint Inhibitors

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Blog

Cellular & Gene Therapy: Implications on Drug Development

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Blog

PBPK Modeling & Simulation in Drug Development

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Blog

New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings

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Webinar

The Challenges of Cancer Immunotherapy Development and Ensuring Durability of Response

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Blog

The Importance of Natural History Study to Rare Disease Drug Development

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Blog

Allucent’s Audit-Ready Approach to Database Build

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Blog

The Importance of Clinical Trial Transparency for Drug Development

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Blog

Current Trends in Systemic Lupus Erythematosus (SLE) Trials

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Blog

The COVID 19 Map per ClinicalTrial Gov

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Blog

How to Avoid Clinical Trials Using Modeling & Simulation

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Blog

New FDA Guidances for July 2020 and Upcoming Advisory Committee Meetings

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Blog

Allucent Releases Updated Paper on the Impact of COVID on Clinical Research

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Blog

Benefits & Uses of QSP in Drug Development

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Webinar

The Value of Orphan Drug Designation in your Drug Development Program

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Blog

Immuno-Oncology Updates in the Virtual Era - ASCO 2020

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White Paper

Advancing Cancer Vaccines to the Forefront of Immunotherapy

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Blog

6 Study Adaptations to Keep Studies Moving Despite COVID-19 Pandemic

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Blog

Managing Patient Enrollment in Acromegaly Rare Disease Studies

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Blog

New FDA Guidances for June 2020 and Upcoming Advisory Committee Meetings

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Blog

Brexit is Here - Is Your Clinical Trial Ready?

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Blog

Are You Ready for the New European Clinical Trial Regulation?

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Webinar

Future Proofing Inflammatory Bowel Disease Diagnosis & Clinical Trials

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Blog

Clinical Research Regulation in the Netherlands

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Blog

The Benefits of Conducting Clinical Research in Russia

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Blog

Current Trends in Allergy Immunotherapy

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Webinar

Advancing Cancer Vaccines to Move to the Forefront of Immunotherapy

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Blog

Medical Data Reviewer: Allucent's Secret to Study Success

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Blog

Challenges Working with Terminally-Ill Patients in an International Rare Disease Study

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Blog

Natural History - Case Study: Ultra Rare Disease in Subjects Aged 3 Years and Younger

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Blog

How Technology Makes Virtual Clinical Pharmacology Phase 1 Studies Possible

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Blog

Complexities of Combining Adults into Protocol with Pediatrics and Adolescents

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Webinar

Pre-Anticipation: Anticipating Obstacles to Approval Before Phase I in Oncology Drug Development

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Blog

How Rave CSA Supports Remote Monitoring in COVID-19

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Blog

Points to Consider in Drug Development of Biologics and Small Molecules

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Blog

Conducting Clinical Trials in South Africa: A Revitalized Environment

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Blog

What’s New Health Canada?

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Blog

DISCOVER 360: Allucent’s Comprehensive Approach to Site Selection

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Webinar

Maintaining Momentum: Applying Recent Regulatory Guidance in the Midst of the Coronavirus

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Blog

Allergy Immunotherapy in Adult and Pediatric Subjects with Peanut Allergy

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Blog

Cancer, COVID-19, Continuity

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Blog

Consideration for Ongoing Clinical Trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic

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Blog

What is Toxicokinetics (TK)?

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Blog

Understanding the New Asthma Guidelines

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Blog

What are the Regulatory Differences Between an NDA and BLA?

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Blog

Multicenter Phase III Study Efficacy of mAb Treatment for Ventilator-Associated Pneumonia (VAP)

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Blog

Ethically Consenting Patients in Ventilator-Associated Studies

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Blog

The Future of Rare Disease Research

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Blog

When to Use 505(b)(1) & 505(b)(2) Pathways for New Drugs and Common Misconceptions

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Blog

The Use of Drug Repurposing in Rare Disease Research

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Blog

Phase I Oncology PD-1 Inhibitor Enrolled 78 Days Early

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Blog

The Use of Gene Therapies in Rare Disease Research

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Blog

The Use of Oligonucleotide Therapies in Rare Disease Research

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Blog

The Use of Protein Replacement Therapies in Rare Disease Research

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Blog

Effective Cohort Management in Early Phase Oncology Trials

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Blog

The Use of Antibody Therapy in Rare Disease Research

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Blog

Three Blockbuster Approved Cancer Drug Launches Expected in 2020

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Blog

The Proposal Manager Necessity

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Blog

Trends in Small Molecule Rare Disease Research

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Blog

Key IND-Enabling Studies

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Blog

Rare Disease Research and the Road Ahead

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Article

Chronic Lymphocytic Leukaemia: Current and Emerging Treatment Options

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Webinar

Enrollment, Enrichment, and Monitoring Strategies to Accelerate Phase 3 Clinical Trials in NASH

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Blog

What are Adaptive Design Clinical Trials?

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Blog

5 Common FDA Applications for Drugs & Biologics

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Webinar

How Feasible is Feasibility in Clinical Trials?

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Blog

What is Steady-State Concentration in Pharmacokinetics?

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Blog

Lessons Learned From a Phase II Influenza Clinical Trial

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Blog

Tissue-Agnostic Therapeutics and Biomarkers in Oncology

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Blog

9 Tips for Preparing a Successful New Drug Application (NDA)

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Blog

What are Real-World Data and How Can they Benefit Drug Development?

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Blog

Risk Evaluation and Mitigation Strategy: Tipping the Balance for FDA Approval

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Webinar

Getting your ducks in a row: Successful Management of Large eCTD Submissions

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Blog

What is Allometric Scaling and How Does it Support Drug Development?

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Blog

To the Rescue: A New Hope for Your Development Program

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Blog

Completing a Rescue Study Transition - How Much Time Do You Need?

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Blog

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White Paper

Journal for Clinical Studies: Combination Approaches in Immuno-Oncology Trials: New Horizons for Multiple Tumor Indications

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Webinar

Mind the Gap(s): Early Identification of Issues is Key for a Successful NDA or BLA

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Blog

Best Practices in Clinical Study Protocol Writing

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Blog

Types of Marketing Exclusivity in Drug Development

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Blog

What is a Human Mass Balance Study?

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Blog

Importance of Natural History Studies to Rare Disease Drug Development

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Blog

3 Rare Disease Challenges Overcome From A Recent Phase 3 Pivotal Study

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Blog

5 Key Considerations Non-EU Based Sponsors must have for GDPR Compliance in Clinical Trials

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Blog

Pharmacokinetics in Patients with Hepatic Impairment

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Blog

Surrogate Endpoints – Neither the End nor the Point

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Blog

How to Successfully Prepare for Your Pediatric Study Plan

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Poster

Overview of immuno-oncology clinical trial conduct and design investigating combination therapies

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Blog

What to Expect following Your Marketing Application Submission

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Blog

New FDA Guidance on Natural History Studies for Rare Diseases

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Blog

Dose Selection for Cellular and Gene Therapies

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Blog

eCTD Regulatory Submissions: Hints & Common Mistakes to Avoid

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Blog

Does the FDA Esketamine Approval Open the Door for Enrichment Trial Designs in Psychiatry?

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Blog

Intrinsic and Extrinsic Factors in Drug Development

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Blog

Let's Talk About Patient Engagement

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Blog

Revised FDA Guidance on Developing Rare Disease Therapies

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Blog

Pharmacogenetics - Tailoring Your Product to Fit the Genes

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Blog

Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products

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Blog

Pharmacokinetic Considerations for Topical Medications

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Blog

New Year New FDA Strategic Framework on Real World Evidence Program

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Blog

The Path to IND Part 2: Supporting Clinical Study Design and Dosing

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Blog

What is Population Pharmacokinetic (popPK) Analysis?

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Blog

The Path to IND Part 1: Milestones & Common Roadblocks

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White Paper

Journal for Clinical Studies editorial - Landscape of early-phase oncology studies in the Netherlands

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Blog

Why Do Clinical Trials Fail?

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Blog

What is the Difference Between ANDAs & 505(b)(2) NDAs?

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Blog

Combination immunotherapy: The latest revolution in cancer treatment

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Blog

What is Noncompartmental Pharmacokinetic Analysis?

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Blog

What is Model-Informed Drug Development?

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Blog

Metabolites: Formation, Identification, and Impact on Drug Development

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Blog

What is the Difference Between PBPK and PopPK Modeling?

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Blog

IND Requirements and Exemptions

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Blog

New Meeting Opportunities with FDA through the Model-Informed Drug Development (MIDD) Pilot Program

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Blog

Exception from Informed Consent in Emergency Research

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Blog

Submitting IND Safety Reports using us-regional DTD v3.3 versus v2.01: What’s the Difference?

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Blog

Understanding the Cost of Pharmacokinetic & Pharmacodynamic Analyses

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Blog

What Are CAR T-Cell Therapies?

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Blog

Monoclonal Antibodies: Past, Present and Future

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Blog

Bioequivalence Studies to Support Abbreviated New Drug Applications

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Blog

Pharmacokinetic Considerations for Repeat-Dosing

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Blog

Compassionate Use: providing cancer care outside trials

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Blog

Cancer Immunotherapy: A New Hope

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Blog

A New Expedited Review Designation: Regenerative Advanced Therapy

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Transparency Initiatives at Health Canada

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Blog

Precision Medicine and the FDA

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Blog

CIMT 2016 - Rise of mRNA therapeutics, a relatively new class of treatment

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Blog

CIMT 2016 "Mechanisms of efficacy in cancer immunotherapy"

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Poster

Comparison of Phase I/II trials regarding antigen-specific versus non-specific anticancer immunotherapies

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Blog

Jump on the Development Safety Update Report (DSUR) Bandwagon!

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Blog

The FDA Wants To Hear Patients’ Voices

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Blog

PK/PD Analysis Potentially Eliminates the Need of a Thorough QT QTc Study

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Blog

'Inhibit the inhibitor' - it's all about PD-(L)1 inhibitors in cancer treatment

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Poster

Comparison of study designs, objectives and results of Phase I trials with cytotoxic versus non-cytotoxic anticancer agents

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White Paper

Put to the Test

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Blog

Top Five Mistakes in Clinical Protocol Design

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