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

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What is Clinical Pharmacology?

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Smarter Drug Development for Rare Diseases

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

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

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

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Clinical Trials Today: Recent Milestones in Rare Cancer Research

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Conducting Clinical Trials in Rare Oncology

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Rare Disease Research in Central and Eastern Europe

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Understanding the Importance of Location in Rare Disease Studies

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Impact of COVID-19 on Rare Disease Research

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Challenges to Research in the Age of COVID

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When Will Patients Return? The COVID Impact

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

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What’s Happening in Ulcerative Colitis Trials Right Now?

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8 Strategies for Navigating Clinical Studies During COVID-19

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6 Tools Used To Achieve a Clean & Reliable Database Lock

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

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

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What is the Difference Between Microbiome and Microbiota?

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Understanding the Connection Between COVID-19 and VAP

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Current and Emerging Therapies for Patients With Multiple Myeloma

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Improving Informed Consent in Clinical Trials

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Understanding the 3 Types of Clinical Trial Monitoring

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New FDA Guidance for October 2020 and Upcoming Advisory Committee Meetings

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New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings

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The Importance of Natural History Study to Rare Disease Drug Development

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Allucent’s Audit-Ready Approach to Database Build

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Current Trends in Systemic Lupus Erythematosus (SLE) Trials

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The COVID 19 Map per ClinicalTrial Gov

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New FDA Guidances for July 2020 and Upcoming Advisory Committee Meetings

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

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Immuno-oncology updates in the virtual era - ASCO 2020

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

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Managing Patient Enrollment in Acromegaly Rare Disease Studies

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New FDA Guidances for June 2020 and Upcoming Advisory Committee Meetings

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Brexit is here - Is your clinical trial-ready?

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Are you ready for the new European clinical trial regulation?

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Clinical Research Regulation in the Netherlands

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The Benefits of Conducting Clinical Research in Russia

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Current Trends in Allergy Immunotherapy

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Medical Data Reviewer: Allucent's Secret to Study Success

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

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

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Complexities of Combining Adults into Protocol with Pediatrics and Adolescents

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How Rave CSA Supports Remote Monitoring in COVID-19

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Conducting Clinical Trials in South Africa: A Revitalized Environment

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What’s New Health Canada?

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DISCOVER 360: Allucent’s Comprehensive Approach to Site Selection

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Allergy Immunotherapy in Adult and Pediatric Subjects with Peanut Allergy

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Cancer, COVID-19, Continuity

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Consideration for ongoing clinical trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic

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Understanding the New Asthma Guidelines

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

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Ethically Consenting Patients in Ventilator-Associated Studies

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The Future of Rare Disease Research

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The Use of Drug Repurposing in Rare Disease Research

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Phase I Oncology PD-1 Inhibitor Enrolled 78 Days Early

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The Use of Gene Therapies in Rare Disease Research

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The Use of Oligonucleotide Therapies in Rare Disease Research

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The Use of Protein Replacement Therapies in Rare Disease Research

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Effective Cohort Management in Early Phase Oncology Trials

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The Use of Antibody Therapy in Rare Disease Research

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Three blockbuster approved cancer drug launches expected in 2020

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The Proposal Manager Necessity

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Trends in Small Molecule Rare Disease Research

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Rare Disease Research and the Road Ahead

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Lessons Learned From a Phase II Influenza Clinical Trial

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To the Rescue: A New Hope for Your Development Program

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

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Importance of Natural History Studies to Rare Disease Drug Development

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

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

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New FDA Guidance on Natural History Studies for Rare Diseases

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

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Lets talk about Patient Engagement

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Revised FDA Guidance on Developing Rare Disease Therapies

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Pharmacogenetics- Tailoring your product to fit the genes

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

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New Year New FDA Strategic Framework on Real World Evidence Program

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Combination immunotherapy: The latest revolution in cancer treatment

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

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Exception from Informed Consent in Emergency Research

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

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Compassionate Use: providing cancer care outside trials

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CANCER IMMUNOTHERAPY: A NEW HOPE

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A New Expedited Review Designation: Regenerative Advanced Therapy

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Transparency Initiatives at Health Canada

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Precision Medicine and the FDA

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

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CIMT 2016 "Mechanisms of efficacy in cancer immunotherapy"

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

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The FDA Wants To Hear Patients’ Voices

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

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Top Five Mistakes in Clinical Protocol Design

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