Resources

Blog

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

READ MORE

Blog

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

READ MORE

Blog

How to Overcome Challenges in Combination Immunotherapy Clinical Trials

READ MORE

Guide

When should you incorporate CPMS?

READ MORE

Podcast

Operationalizing Cell and Gene Therapy Trials

READ MORE

Podcast

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

READ MORE

Podcast

Defining the Regulatory Roadmap for Product Success

READ MORE

Article

Spotlight on oncology drug development and its future

READ MORE

Article

Focusing on smaller biotechs to have a big impact on society

READ MORE

Article

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

READ MORE

Article

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

READ MORE

Guide

5 Areas Where a Biostatistician Can Help

READ MORE

Guide

A Guide to Scientific Advice

READ MORE

White Paper

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

READ MORE

Blog

Developing CNS Neurotherapeutics with Cerebrospinal PK/PD Clinical Studies

READ MORE

Blog

Accelerating Drug Development of Innovative Oncologic Agents: Master Protocols

READ MORE

Blog

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

READ MORE

Blog

What is Pharmacodynamics?

READ MORE

Blog

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

READ MORE

Webinar

Benefits of Bayesian Dose Escalation Designs for Oncology Studies

READ MORE

Webinar

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

READ MORE

Guide

A Snapshot of Gap Analysis

READ MORE

Blog

Risk Assessment: Traditional and Novel Approaches

READ MORE

Blog

The Role of Clinical Pharmacology in New Drug Development

READ MORE

Blog

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

READ MORE

Article

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

READ MORE

Guide

3 Tips for IMPD Success

READ MORE

Blog

What is Clinical Pharmacology?

READ MORE

Blog

Smarter Drug Development for Rare Diseases

READ MORE

Case Study

Grass & Birch Allergy Phase II Parallel Studies

READ MORE

Blog

The Essential Role of the CMC Expert

READ MORE

Blog

Rare Disease Research – Why we do what we do

READ MORE

Blog

A Regulatory Perspective on Cell and Gene Therapy in Oncology

READ MORE

Webinar

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

READ MORE

Blog

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

READ MORE

Blog

Leveraging Modeling & Simulation for Pediatric Drug Development

READ MORE

Blog

Developing Oligonucleotide Therapies

READ MORE

Blog

What is Pharmacokinetics and ADME?

READ MORE

Blog

Optimizing Trial Efficiency with Bayesian Dose Escalation Designs

READ MORE

Blog

Understanding How PK Data and CDISC Work Together

READ MORE

Blog

The Potential of Biosimilars – for Drug Makers and Patients

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Blog

Common Clinical Pharmacology Mistakes to Avoid in Drug Development

READ MORE

Blog

Compartmental Modeling in Pharmacokinetics

READ MORE

Webinar

Navigating Regulatory Strategies for Cellular & Gene Therapies

READ MORE

Blog

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

READ MORE

Blog

Introduction to Healthcare-Associated Infections (HAIs)

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Blog

FDA Project Optimus: Selecting the Optimal Dose for Oncology Therapeutics

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Article

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

READ MORE

Blog

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

READ MORE

Blog

Pharmacokinetic Parameters in Drug Development

READ MORE

Blog

Adaptive Design Considerations for Early Phase Oncology Trials

READ MORE

Case Study

Indolent NHL Immuno-Oncology Rescue Study

READ MORE

Blog

Respiratory Viral Infections: Progress and Innovation

READ MORE

Blog

Understanding Long-Haul COVID

READ MORE

Blog

The Role of Liquid Biopsies in the Clinical Trial Setting

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Blog

Understanding CDISC SEND Data and How to Be Compliant

READ MORE

Blog

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

READ MORE

Blog

Infectious Disease Research: Importance of Site Location in Clinical Trials

READ MORE

Blog

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

READ MORE

Blog

Leveraging Autoimmune Therapies in Infectious Disease and Vaccine Research

READ MORE

Blog

Pre-IND Meeting Guide: Benefits & How to Prepare

READ MORE

Blog

Autoimmune Clinical Trials: A Brief Review of Recent Autoimmune Research

READ MORE

Blog

Important Milestones in Autoimmune Research: A Timeline of Autoimmunity

READ MORE

Blog

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

READ MORE

Blog

When Should You Hire a Clinical Pharmacologist?

READ MORE

Blog

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

READ MORE

Webinar

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

READ MORE

Blog

What Is CDISC and What Are CDISC Data Standards?

READ MORE

Blog

Allergy Clinical Trials: Recent Asthma and Allergy Research in Review

READ MORE

Blog

FDA Orphan Drug Designation for Rare Diseases

READ MORE

Blog

Important Milestones in Allergy Research and Clinical Trials: A Timeline

READ MORE

Blog

Site Location Selection: Key to Conducting Better Allergy Clinical Trials

READ MORE

Blog

Allergy Immunotherapy in Review: New Developments in Immune Therapy

READ MORE

Blog

Common Misconceptions About PBPK Modeling

READ MORE

White Paper

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

READ MORE

Blog

Cancer clinical trials: Recent oncology research studies in review

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Blog

CAR T-Cell Therapy Challenges to Development & Approval

READ MORE

Blog

Clinical Trials Today: Recent Milestones in Rare Cancer Research

READ MORE

Blog

What is a 505(b)(2)?

READ MORE

Blog

Conducting Clinical Trials in Rare Oncology

READ MORE

Blog

Rare Disease Research in Central and Eastern Europe

READ MORE

Blog

Understanding the Importance of Location in Rare Disease Studies

READ MORE

Presentation

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

READ MORE

Blog

Impact of COVID-19 on Rare Disease Research

READ MORE

Blog

Common Misconceptions About QSP Modeling

READ MORE

Blog

Challenges to Research in the Age of COVID

READ MORE

Blog

Cost-Effective Techniques for Creating QSP Models

READ MORE

Blog

When Will Patients Return? The COVID Impact

READ MORE

Blog

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

READ MORE

Blog

What’s Happening in Ulcerative Colitis Trials Right Now?

READ MORE

Blog

Understanding Current and Future Therapeutic Options for COVID-19

READ MORE

Blog

8 Strategies for Navigating Clinical Studies During COVID-19

READ MORE

Blog

6 Tools Used To Achieve a Clean & Reliable Database Lock

READ MORE

Blog

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

READ MORE

Webinar

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

READ MORE

Blog

Fostering Inclusion and Diversity in Clinical Trials

READ MORE

Blog

Risk Management: Your Foundation for Better Project Management

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Blog

What is the Difference Between Microbiome and Microbiota?

READ MORE

Blog

Understanding the Connection Between COVID-19 and VAP

READ MORE

Blog

Current and Emerging Therapies for Patients With Multiple Myeloma

READ MORE

Blog

The Role of Pre-Clinical Pharmacokinetics in Early Drug Development

READ MORE

Webinar

Development and Implementation of the Comprehensive Pharmacokinetics Plan

READ MORE

Webinar

Next Generation Strategies for Orphan Drug Development

READ MORE

Blog

Improving Informed Consent in Clinical Trials

READ MORE

Blog

Understanding the 3 Types of Clinical Trial Monitoring

READ MORE

Blog

New FDA Guidance for October 2020 and Upcoming Advisory Committee Meetings

READ MORE

White Paper

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

READ MORE

Blog

Cellular & Gene Therapy: Implications on Drug Development

READ MORE

Blog

PBPK Modeling & Simulation in Drug Development

READ MORE

Blog

New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings

READ MORE

Webinar

The Challenges of Cancer Immunotherapy Development and Ensuring Durability of Response

READ MORE

Blog

The Importance of Natural History Study to Rare Disease Drug Development

READ MORE

Blog

Allucent’s Audit-Ready Approach to Database Build

READ MORE

Blog

The Importance of Clinical Trial Transparency for Drug Development

READ MORE

Blog

Current Trends in Systemic Lupus Erythematosus (SLE) Trials

READ MORE

Blog

The COVID 19 Map per ClinicalTrial Gov

READ MORE

Blog

How to Avoid Clinical Trials Using Modeling & Simulation

READ MORE

Blog

New FDA Guidances for July 2020 and Upcoming Advisory Committee Meetings

READ MORE

Blog

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

READ MORE

Blog

Benefits & Uses of QSP in Drug Development

READ MORE

Webinar

The Value of Orphan Drug Designation in your Drug Development Program

READ MORE

Blog

Immuno-oncology updates in the virtual era - ASCO 2020

READ MORE

White Paper

Advancing Cancer Vaccines to the Forefront of Immunotherapy

READ MORE

Blog

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

READ MORE

Blog

Managing Patient Enrollment in Acromegaly Rare Disease Studies

READ MORE

Blog

New FDA Guidances for June 2020 and Upcoming Advisory Committee Meetings

READ MORE

Blog

Brexit is here - Is your clinical trial-ready?

READ MORE

Blog

Are you ready for the new European clinical trial regulation?

READ MORE

Webinar

Future Proofing Inflammatory Bowel Disease Diagnosis & Clinical Trials

READ MORE

Blog

Clinical Research Regulation in the Netherlands

READ MORE

Blog

The Benefits of Conducting Clinical Research in Russia

READ MORE

Blog

Current Trends in Allergy Immunotherapy

READ MORE

Webinar

Advancing Cancer Vaccines to Move to the Forefront of Immunotherapy

READ MORE

Blog

Medical Data Reviewer: Allucent's Secret to Study Success

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Blog

How Technology Makes Virtual Clinical Pharmacology Phase 1 Studies Possible

READ MORE

Blog

Complexities of Combining Adults into Protocol with Pediatrics and Adolescents

READ MORE

Webinar

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

READ MORE

Blog

How Rave CSA Supports Remote Monitoring in COVID-19

READ MORE

Blog

Points to Consider in Drug Development of Biologics and Small Molecules

READ MORE

Blog

Conducting Clinical Trials in South Africa: A Revitalized Environment

READ MORE

Blog

What’s New Health Canada?

READ MORE

Blog

DISCOVER 360: Allucent’s Comprehensive Approach to Site Selection

READ MORE

Webinar

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

READ MORE

Blog

Allergy Immunotherapy in Adult and Pediatric Subjects with Peanut Allergy

READ MORE

Blog

Cancer, COVID-19, Continuity

READ MORE

Blog

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

READ MORE

Blog

What is Toxicokinetics (TK)?

READ MORE

Blog

Understanding the New Asthma Guidelines

READ MORE

Blog

What are the Regulatory Differences Between an NDA and BLA?

READ MORE

Blog

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

READ MORE

Blog

Ethically Consenting Patients in Ventilator-Associated Studies

READ MORE

Blog

The Future of Rare Disease Research

READ MORE

Blog

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

READ MORE

Blog

The Use of Drug Repurposing in Rare Disease Research

READ MORE

Blog

Phase I Oncology PD-1 Inhibitor Enrolled 78 Days Early

READ MORE

Blog

The Use of Gene Therapies in Rare Disease Research

READ MORE

Blog

The Use of Oligonucleotide Therapies in Rare Disease Research

READ MORE

Blog

The Use of Protein Replacement Therapies in Rare Disease Research

READ MORE

Blog

Effective Cohort Management in Early Phase Oncology Trials

READ MORE

Blog

The Use of Antibody Therapy in Rare Disease Research

READ MORE

Blog

Three blockbuster approved cancer drug launches expected in 2020

READ MORE

Blog

The Proposal Manager Necessity

READ MORE

Blog

Trends in Small Molecule Rare Disease Research

READ MORE

Blog

Key IND-Enabling Studies

READ MORE

Blog

Rare Disease Research and the Road Ahead

READ MORE

Article

Chronic Lymphocytic Leukaemia: Current and Emerging Treatment Options

READ MORE

Webinar

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

READ MORE

Blog

What are Adaptive Design Clinical Trials?

READ MORE

Blog

5 Common FDA Applications for Drugs & Biologics

READ MORE

Webinar

How Feasible is Feasibility in Clinical Trials?

READ MORE

Blog

What is Steady-State Concentration in Pharmacokinetics?

READ MORE

Blog

Lessons Learned From a Phase II Influenza Clinical Trial

READ MORE

Blog

Tissue-Agnostic Therapeutics and Biomarkers in Oncology

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Webinar

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

READ MORE

Blog

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

READ MORE

Blog

To the Rescue: A New Hope for Your Development Program

READ MORE

Blog

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

READ MORE

Blog

READ MORE

White Paper

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

READ MORE

Webinar

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

READ MORE

Blog

Best Practices in Clinical Study Protocol Writing

READ MORE

Blog

Types of Marketing Exclusivity in Drug Development

READ MORE

Blog

What is a Human Mass Balance Study?

READ MORE

Blog

Importance of Natural History Studies to Rare Disease Drug Development

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Blog

Pharmacokinetics in Patients with Hepatic Impairment

READ MORE

Blog

Surrogate Endpoints – Neither the End nor the Point

READ MORE

Blog

How to Successfully Prepare for Your Pediatric Study Plan

READ MORE

Poster

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

READ MORE

Blog

What to Expect following Your Marketing Application Submission

READ MORE

Blog

New FDA Guidance on Natural History Studies for Rare Diseases

READ MORE

Blog

Dose Selection for Cellular and Gene Therapies

READ MORE

Blog

eCTD Regulatory Submissions: Hints & Common Mistakes to Avoid

READ MORE

Blog

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

READ MORE

Blog

Intrinsic and Extrinsic Factors in Drug Development

READ MORE

Blog

Lets talk about Patient Engagement

READ MORE

Blog

Revised FDA Guidance on Developing Rare Disease Therapies

READ MORE

Blog

Pharmacogenetics- Tailoring your product to fit the genes

READ MORE

Blog

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

READ MORE

Blog

Pharmacokinetic Considerations for Topical Medications

READ MORE

Blog

New Year New FDA Strategic Framework on Real World Evidence Program

READ MORE

Blog

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

READ MORE

Blog

What is Population Pharmacokinetic (popPK) Analysis?

READ MORE

Blog

The Path to IND Part 1: Milestones & Common Roadblocks

READ MORE

White Paper

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

READ MORE

Blog

Why Do Clinical Trials Fail?

READ MORE

Blog

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

READ MORE

Blog

Combination immunotherapy: The latest revolution in cancer treatment

READ MORE

Blog

What is Noncompartmental Pharmacokinetic Analysis?

READ MORE

Blog

What is Model-Informed Drug Development?

READ MORE

Blog

Metabolites: Formation, Identification, and Impact on Drug Development

READ MORE

Blog

What is the Difference Between PBPK and PopPK Modeling?

READ MORE

Blog

IND Requirements and Exemptions

READ MORE

Blog

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

READ MORE

Blog

Exception from Informed Consent in Emergency Research

READ MORE

Blog

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

READ MORE

Blog

Understanding the Cost of Pharmacokinetic & Pharmacodynamic Analyses

READ MORE

Blog

What Are CAR T-Cell Therapies?

READ MORE

Blog

Monoclonal Antibodies: Past, Present and Future

READ MORE

Blog

Bioequivalence Studies to Support Abbreviated New Drug Applications

READ MORE

Blog

Pharmacokinetic Considerations for Repeat-Dosing

READ MORE

Blog

Compassionate Use: providing cancer care outside trials

READ MORE

Blog

CANCER IMMUNOTHERAPY: A NEW HOPE

READ MORE

Blog

A New Expedited Review Designation: Regenerative Advanced Therapy

READ MORE

Blog

Transparency Initiatives at Health Canada

READ MORE

Blog

Precision Medicine and the FDA

READ MORE

Blog

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

READ MORE

Blog

CIMT 2016 "Mechanisms of efficacy in cancer immunotherapy"

READ MORE

Poster

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

READ MORE

Blog

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

READ MORE

Blog

The FDA Wants To Hear Patients’ Voices

READ MORE

Blog

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

READ MORE

Blog

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

READ MORE

Poster

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

READ MORE

White Paper

Put to the Test

READ MORE

Blog

Top Five Mistakes in Clinical Protocol Design

READ MORE