Resources

Blog

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

Nuventra 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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E-book

Best Practices and Overview of Recent Asthma and Allergy Research 2021

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E-book

Best Practices and Overview of Oncology Clinical Trials 2021

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E-book

Challenges & Opportunities in Rare Disease Research

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E-book

Conducting Clinical Trials During COVID-19

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E-book

Analyzing The Systemic Lupus Erythematosus Competitive Landscape

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E-book

The COVID-19 Clinical Landscape and Its Impact on Clinical Research and the Biopharmaceutical Sector

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E-book

The Formula for Success in Rare Disease Research

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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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Blog

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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Optimizing Trial Efficiency with Bayesian Dose Escalation Designs

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Webinar

Webinar | Concentration-QT Analysis: Saving Time and Resources with Modeling

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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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Webinar

Navigating Regulatory Strategies for Cellular & Gene Therapies

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Webinar

Webinar | Navigating Regulatory Strategies for Cellular & Gene Therapies

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Introduction to Healthcare-Associated Infections (HAIs)

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

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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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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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Blog

Understanding Long-Haul COVID

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The Role of Liquid Biopsies in the Clinical Trial Setting

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Webinar

Webinar | Using PBPK Modeling in Pregnancy and Lactation Studies

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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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Leveraging Autoimmune Therapies in Infectious Disease and Vaccine Research

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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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Webinar

Webinar | Regulatory Pathways for Drugs, Devices, & Combination Products

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

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Blog

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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Webinar

Webinar | Roundtable Panel Discussion: Approaches to Determining FIH Doses

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Blog

Allergy Clinical Trials: Recent Asthma and Allergy Research in Review

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Important Milestones in Allergy Research and Clinical Trials: A Timeline

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Site Location Selection: Key to Conducting Better Allergy Clinical Trials

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Allergy Immunotherapy in Review: New Developments in Immune Therapy

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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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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

Clinical Trials Today: Recent Milestones in Rare Cancer Research

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Blog

Conducting Clinical Trials in Rare Oncology

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Webinar

Webinar | Cellular & Gene Therapy 101

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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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Presentation

5 Questions with Geoffrey Banks, Ph.D.

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Blog

Impact of COVID-19 on Rare Disease Research

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Blog

Challenges to Research in the Age of COVID

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Brochure

Overview Brochure

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Brochure

Oncology Brochure

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Webinar

Webinar | Intro to PBPK & QSP: Modeling Approaches for All Stages of Drug Development

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Blog

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

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

Risk Management: Your Foundation for Better Project Management

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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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Presentation

5 Questions with Deborah (Debby) Ann Smith, Pharm.D.

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Webinar

Webinar | Micro-Dosing: Effects of an Investigational Drug on PK of Concomitant Medications

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Webinar

Development and Implementation of the Comprehensive Pharmacokinetics Plan

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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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Presentation

5 Questions with Mary Barecki-Roach

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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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Webinar

Webinar | Pediatric Drug Development: Allometry and Other Empirical Models

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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

Current Trends in Systemic Lupus Erythematosus (SLE) Trials

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Presentation

5 Questions with Suliman Al-Fayoumi, Ph.D., M.B.A

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Webinar

Webinar | Drug Development Considerations for Dermatology:
More Than Skin Deep

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Blog

The COVID 19 Map per ClinicalTrial Gov

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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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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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Presentation

5 Questions with Venkateswari (Eswari) Muthukrishnan, Ph.D.

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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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Webinar

Webinar | Allometric Scaling: Common Misconceptions During Drug Development

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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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Case Study

Ultra-Rare Disease Studying Subjects Aged 3 Years and Younger

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Blog

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

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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

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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Webinar

Webinar | Artificial Intelligence and Applications of Deep Learning in Drug Development

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Presentation

5 Questions with Devin Welty, Ph.D.

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Case Study

Subcutaneous 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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Case Study

Recruitment of Patients in a Phase III Systemic Lupus Erythematosus Study

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Case Study

Phase I Solid Tumor PD-1 Inhibitor Study Enrolled 78 Days Early

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Case Study

Recruitment of Patients in a Phase III Systemic Lupus Erythematosus Study

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Case Study

Pulmonary Arterial Hypertension in Eastern Europe

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Case Study

Post Herpetic Neuralgia

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Case Study

Glioblastoma Anaplastic Astrocytoma

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Case Study

Allergic Rhinitis

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Case Study

Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

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Case Study

Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

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Case Study

Phase I/II Trial Involving Preterm Neonates

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Blog

Understanding the New Asthma Guidelines

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Case Study

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

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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

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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Presentation

5 Questions with Betty Hussey, Pharm.D.

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Blog

The Use of Gene Therapies in Rare Disease Research

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Webinar

Webinar | Clinical Pharmacology 101: The Purpose of Clinical Pharmacology Studies in Drug Development

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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

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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Webinar

How Feasible is Feasibility in Clinical Trials?

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Blog

Lessons Learned From a Phase II Influenza Clinical Trial

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Webinar

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

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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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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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Webinar

Webinar | Designing Smarter Clinical Trials with Modeling & Simulation Approaches

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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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Poster

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

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Blog

New FDA Guidance on Natural History Studies for Rare Diseases

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Blog

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

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Blog

Lets 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

New Year New FDA Strategic Framework on Real World Evidence Program

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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

Combination immunotherapy: The latest revolution in cancer treatment

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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

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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Blog

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

'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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