Resources

Empowering Small Biotechs: Conquering Clinical Trial Challenges with Data Management Champions
The Changing Paradigm of Regulatory Submissions: Embracing Automation, Gen AI, and Innovation for Faster Approvals
Cell and Gene Therapy Clinical Trials: How to Successfully Operationalize a Trial of Prolonged Duration
Podcast: Artificial Intelligence, GCP Compliance, & Inspection Readiness in Clinical Trials
Evolving Advisory Committee Processes: Key Updates From ODAC
Translational Clinical Pharmacology in Cell and Gene Therapy
Neurotoxic Risks in Therapeutics: Nonclinical Considerations
Achieving Operational Excellence in Clinical Research Organizations: A Catalyst for Biotech Success
EU Pharmaceutical Legislation Reform - Towards a Resolution
Strengthen Your Regulatory Submissions Through Strategic Storyboarding
Crossover Designs in Oncology: Statistical Perspectives
Podcast: Advancing Oncology Research: Regulatory & Development Path for ADCs & RDCs
Podcast: Strategic Alliances in the Development and Execution of Pharmacovigilance Strategy
Optimizing Your Clinical Development Plan: Strategies for Biotech Success
Enabling Patient-Centric Drug Development: Opportunity for Clinical Pharmacology to Leverage Innovation and Advance Diversity and Inclusion in Clinical Trials
Navigating Regulatory Challenges: A Collaborative Journey to FDA Approval
Sample Size Re-Estimation: Risk Mitigation at the Planning Stage
Automated Exploratory Data Analysis to Support Pre-Specified C‑QT Models
Exploring the Complexities of Healthcare-Associated Infections: Challenges and Insights
Translating Complex Data into Actionable Insights, to Create Big Value for Smaller Biotech Companies
Clinical Pharmacology Studies to Support Filing Packages and Labeling
Sifting Through Rarity: Advanced Patient Screening for Rare Disease Trials
Using PBPK to Predict CSF and Brain Exposure of CNS Penetrant Drugs
Mastering Clinical Trial Design: Will FDA’s Latest Guidance on Master Protocols Encourage Increased Adoption?
Unleashing the Power of Predictive Modeling: A Journey to Safe and Effective Dosing for a CNS Drug
Risk Assessment of Novel Neurotherapeutics: Mechanistic Translation of Preclinical Safety and PK/PD Data to a Clinical Setting
Fast-Tracking Drug Development: Role of Mechanistic PK/PD Modeling
Advancing Excellence in Clinical Programming Solutions
Balancing Act in Preclinical Development: Strategies for Assessing and Managing Neurotoxic Risks in CNS Therapeutics
Cell and Gene Therapy Advancements: Early-Stage CMC Strategies for Exosome Innovation
The Role of Statisticians in Study Design and Why to Engage Them Early
Navigating the Challenges of Clinical Trial Design 
Efficient Clinical Programs and Decision Making Through Model-Informed Drug Development (MIDD)
Pediatric Clinical Trials: Tackling Clinical and Therapeutic Development Challenges Head-On
Anti-Depression Medication: Current Landscape and Product Development Trends
Advancing Oncology Drug Development: The Importance of Single-Arm Trials
A Journey of Collaboration and Future Transformations in Biotech Space
Patient-Centric Approach To Accelerating Clinical Trials
More than Skin Deep: Considerations for Dermatology and Drugs Administered to the Skin
PBPK Modeling for Pediatric Drug Development
Inroads To Approval: Navigating Formal FDA Meetings to Optimize Your Drug Development Program
Exosomes: Unveiling Their Potential in Cell and Gene Therapy
Technical Writing Services with a Clinical Pharmacology Focus
Study Design and Conduct Leveraging Allucent's Clinical Pharmacology Expertise
Population Modeling Capabilities
Model-Informed Drug Development
Begin with the End in Mind Investigational New Drug (IND) Services
Allucent's Expertise in Predicting Human Exposure From Nonclinical Data
505(b)(2) Regulatory Pathway - Clinical Pharmacology Services
Using PBPK to Optimize Magnesium Concentrations in an Intravenous Formulation
Using PBPK to Extrapolate Animal Tissue Concentrations to Humans
Using Modeling and Simulation to Determine FIH Dose
Gene Therapy
Due Diligence to Support a Client’s Decision-Making
Complex Concentration-QT Analysis
Rare Central Nervous System Disease Trials
Cannabis and Cannabis-Derived Products for Therapeutic Development
The Office of Therapeutic Products (OTP): A New Way Forward for Cell and Gene Therapies
Nonhuman Primates (NHPs): FDA Issues Guidance for Use in Nonclinical Safety Studies
Stepwise Paediatric Investigation Plan — Evolutionary or Revolutionary?
FDA Clarifies Policy on Post-COVID Meetings
Let's Extrapolate!
Guide to CTIS Workspace Organization
Overcoming Patient Recruitment Difficulties in Acute Ischemic Stroke Trials
Biometrics Fact Sheet
Lessons Learned as Early Adapters of the EU’s Clinical Trials Regulation
Diversity in clinical trials: Optimizing drug development strategy, leveraging data and increasing efficiency with modeling and simulation.
How to Overcome Challenges in Combination Immunotherapy Clinical Trials
When should you incorporate CPMS?
Operationalizing Cell and Gene Therapy Trials
Why Multinational Clinical Trials are Key to Bringing Novel Therapies to Patients
Defining the Regulatory Roadmap for Product Success
Spotlight on oncology drug development and its future
Focusing on smaller biotechs to have a big impact on society
Big passion for small biotech and its potential to address complex diseases
When it comes to small populations, biotechs need to think big
5 Areas Where a Biostatistician Can Help
A Guide to Scientific Advice
Citeline Report - Executing Early Phase Research In Hematological Oncology: What Matters To Biotech?
Developing CNS Neurotherapeutics with Cerebrospinal PK/PD Clinical Studies
Accelerating Drug Development of Innovative Oncologic Agents: Master Protocols
Long-Term Follow-Up for CGT Trials: Best Practices to Operationalize
What is Pharmacodynamics?
The Role of Statisticians in Study Design and Why to Engage them Early
Benefits of Bayesian Dose Escalation Designs for Oncology Studies
Risk Assessment: Traditional and Novel Approaches to Assess and Manage Risks
A Snapshot of Gap Analysis
Risk Assessment: Traditional and Novel Approaches
The Role of Clinical Pharmacology in New Drug Development
Gap Analysis: The Benefit of Conducting Technical and Regulatory Due Diligence
Allucent Scientists Author Top Downloaded Journal Article in Clinical Pharmacology & Therapeutics in 2021
3 Tips for IMPD Success
What is Clinical Pharmacology?
Smarter Drug Development for Rare Diseases
Grass & Birch Allergy Phase II Parallel Studies
The Essential Role of the CMC Expert in Drug Development
Rare Disease Research – Why We Do What We Do
A Regulatory Perspective on Cell and Gene Therapy in Oncology
Inspection Readiness: What is it, why it matters, and what you need to know to be prepared
Inspection-Readiness: What You Need to Know to Prepare for a GCP Inspection
Leveraging Modeling & Simulation for Pediatric Drug Development
Developing Oligonucleotide Therapies
What is Pharmacokinetics and ADME?
Optimizing Trial Efficiency with Bayesian Dose Escalation Designs
Understanding How PK Data and CDISC Work Together
The Potential of Biosimilars – for Drug Makers and Patients
The Multifaceted Role of the Nonclinical Expert at the Center of Drug Development Teams
The Black Box of Anti-COVID-19 Monoclonal Antibodies: An Overview, Definitions, and Terminology
Expediting Treatments to Oncology Patients in Need: Understanding the FDA’s Accelerated Pathways
Common Clinical Pharmacology Mistakes to Avoid in Drug Development
Compartmental Modeling in Pharmacokinetics
Navigating Regulatory Strategies for Cellular & Gene Therapies
Determining First-in-Human (FIH) Dose for Clinical Studies
Introduction to Healthcare-Associated Infections (HAIs)
How to Use Modeling and Simulation to Optimize a 505(b)(2) Application
Benefits of Using Modeling and Simulation to Design and Interpret Phase 3 Clinical Trials
FDA Project Optimus: Selecting the Optimal Dose for Oncology Therapeutics
The Case for Early Regulatory Consideration for Clinical Development of Chimeric Antigen Receptor T cell (CART)
How to Form a Clinical Pharmacology Strategy for your NDA, BLA, or MAA
Great News from EMA in December: Three New Treatments for COVID-19
Long-Standing Partnerships: Immutep's CEO, Marc Voigt in an interview for CEO Magazine
Cervical Health Awareness Month - Cervical Cancer: Prevention, Detection, Development
Pharmacokinetic Parameters in Drug Development
Adaptive Design Considerations for Early Phase Oncology Trials
Indolent NHL Immuno-Oncology Rescue Study
Respiratory Viral Infections: Progress and Innovation
Understanding Long-Haul COVID
The Role of Liquid Biopsies in the Clinical Trial Setting
What are Good Laboratory Practices (GLP) for Nonclinical Studies?
Benefits of Utilizing the 505(b)(2) Pathway for Prodrugs
Understanding CDISC SEND Data and How to Be Compliant
Important Milestones in Infectious Diseases Clinical Trials: A Timeline of Infectious Disease Research
Infectious Disease Research: Importance of Site Location in Clinical Trials
EU Clinical Trial Regulation: What, When, Who, Why, How?
Leveraging Autoimmune Therapies in Infectious Disease and Vaccine Research
Pre-IND Meeting Guide: Benefits & How to Prepare
Autoimmune Clinical Trials: A Brief Review of Recent Autoimmune Research
Important Milestones in Autoimmune Research: A Timeline of Autoimmunity
Better Clinical Trials: How Does Location Impact Autoimmune Research Studies?
When Should You Hire a Clinical Pharmacologist?
Autoimmune Research in Review: Microbiome, Microbiota, and Immune System Conditions
Roadmap To Marketing Authorisation in Europe: Taking All the Right Turns
What Is CDISC and What Are CDISC Data Standards?
Allergy Clinical Trials: Recent Asthma and Allergy Research in Review
FDA Orphan Drug Designation for Rare Diseases
Important Milestones in Allergy Research and Clinical Trials: A Timeline
Site Location Selection: Key to Conducting Better Allergy Clinical Trials
Allergy Immunotherapy in Review: New Developments in Immune Therapy
Common Misconceptions About PBPK Modeling
Mind the Gap: The Importance of Gap Analysis in Securing Regulatory Approval
Cancer Clinical Trials: Recent Oncology Research Studies in Review
Anticipating Obstacles to Approval Before Your Early Phase Oncology Study: Four Critical Areas to Consider
How to Choose Sites for Cancer Trials: Central and Eastern Europe
CAR T-Cell Therapy Challenges to Development & Approval
Clinical Trials Today: Recent Milestones in Rare Cancer Research
What is a 505(b)(2)?
Conducting Clinical Trials in Rare Oncology
Rare Disease Research in Central and Eastern Europe
Understanding the Importance of Location in Rare Disease Studies
Managing Clinical Trial Risk Strategically: Collaborating for Success With Your Outsourcing Partners
Impact of COVID-19 on Rare Disease Research
Common Misconceptions About QSP Modeling
Challenges to Research in the Age of COVID
Cost-Effective Techniques for Creating QSP Models
When Will Patients Return? The COVID Impact
EMA & FDA Approvals and Recommendations in 2020 for Oncology Drugs and Diagnostics/Devices
What's Happening in Ulcerative Colitis Trials Right Now?
Understanding Current and Future Therapeutic Options for COVID-19
8 Strategies for Navigating Clinical Studies During COVID-19
6 Tools Used To Achieve a Clean & Reliable Database Lock
What is Earned Value Management and Why Use It at a CRO?
Fostering Inclusion and Diversity in Clinical Trials
Webinar | Pharmacogenomics and Pediatric Drug Development: When Are Children Not Little Adults and Why?
Risk Management: Your Foundation for Better Project Management
Clinical Highlights from the First Virtual European Society for Medical Oncology Congress
Strategizing for Your Submission: Planning Ahead for Your NDA or BLA
What is the Difference Between Microbiome and Microbiota?
Understanding the Connection Between COVID-19 and VAP
Current and Emerging Therapies for Patients With Multiple Myeloma
The Role of Pre-Clinical Pharmacokinetics in Early Drug Development
Next Generation Strategies for Orphan Drug Development
Improving Informed Consent in Clinical Trials
Understanding the 3 Types of Clinical Trial Monitoring
New FDA Guidance for October 2020 and Upcoming Advisory Committee Meetings
Current Trends in the Clinical Development of Combination Therapies with Immune Checkpoint Inhibitors
Cellular & Gene Therapy: Implications on Drug Development
PBPK Modeling & Simulation in Drug Development
New FDA Guidances for August 2020 and Upcoming Advisory Committee Meetings
The Challenges of Cancer Immunotherapy Development and Ensuring Durability of Response
The Importance of Natural History Study to Rare Disease Drug Development
Allucent’s Audit-Ready Approach to Database Build
The Importance of Clinical Trial Transparency for Drug Development
Current Trends in Systemic Lupus Erythematosus (SLE) Trials
The COVID 19 Map per ClinicalTrial Gov
How to Avoid Clinical Trials Using Modeling & Simulation
New FDA Guidances for July 2020 and Upcoming Advisory Committee Meetings
Allucent Releases Updated Paper on the Impact of COVID on Clinical Research
Benefits & Uses of QSP in Drug Development
The Value of Orphan Drug Designation in your Drug Development Program
Immuno-Oncology Updates in the Virtual Era - ASCO 2020
Advancing Cancer Vaccines to the Forefront of Immunotherapy
6 Study Adaptations to Keep Studies Moving Despite COVID-19 Pandemic
Managing Patient Enrollment in Acromegaly Rare Disease Studies
New FDA Guidances for June 2020 and Upcoming Advisory Committee Meetings
Brexit is Here - Is Your Clinical Trial Ready?
Are You Ready for the New European Clinical Trial Regulation?
Future Proofing Inflammatory Bowel Disease Diagnosis & Clinical Trials
Clinical Research Regulation in the Netherlands
The Benefits of Conducting Clinical Research in Russia
Current Trends in Allergy Immunotherapy
Advancing Cancer Vaccines to Move to the Forefront of Immunotherapy
Medical Data Reviewer: Allucent's Secret to Study Success
Challenges Working with Terminally-Ill Patients in an International Rare Disease Study
Natural History - Case Study: Ultra Rare Disease in Subjects Aged 3 Years and Younger
How Technology Makes Virtual Clinical Pharmacology Phase 1 Studies Possible
Complexities of Combining Adults into Protocol with Pediatrics and Adolescents
Pre-Anticipation: Anticipating Obstacles to Approval Before Phase I in Oncology Drug Development
How Rave CSA Supports Remote Monitoring in COVID-19
Points to Consider in Drug Development of Biologics and Small Molecules
Conducting Clinical Trials in South Africa: A Revitalized Environment
What’s New Health Canada?
Maintaining Momentum: Applying Recent Regulatory Guidance in the Midst of the Coronavirus
Allergy Immunotherapy in Adult and Pediatric Subjects with Peanut Allergy
Cancer, COVID-19, Continuity
Consideration for Ongoing Clinical Trials: Ensuring Participant Safety and Adapting New Processes during COVID‑19 Pandemic
What is Toxicokinetics (TK)?
Understanding the New Asthma Guidelines
What are the Regulatory Differences Between an NDA and BLA?
Multicenter Phase III Study Efficacy of mAb Treatment for Ventilator-Associated Pneumonia (VAP)
Ethically Consenting Patients in Ventilator-Associated Studies
The Future of Rare Disease Research
When to Use 505(b)(1) & 505(b)(2) Pathways for New Drugs and Common Misconceptions
The Use of Drug Repurposing in Rare Disease Research
Phase I Oncology PD-1 Inhibitor Enrolled 78 Days Early
The Use of Gene Therapies in Rare Disease Research
The Use of Oligonucleotide Therapies in Rare Disease Research
The Use of Protein Replacement Therapies in Rare Disease Research
Effective Cohort Management in Early Phase Oncology Trials
The Use of Antibody Therapy in Rare Disease Research
Three Blockbuster Approved Cancer Drug Launches Expected in 2020
The Proposal Manager Necessity
Trends in Small Molecule Rare Disease Research
Key IND-Enabling Studies
Rare Disease Research and the Road Ahead
Chronic Lymphocytic Leukaemia: Current and Emerging Treatment Options
Enrollment, Enrichment, and Monitoring Strategies to Accelerate Phase 3 Clinical Trials in NASH
What are Adaptive Design Clinical Trials?
5 Common FDA Applications for Drugs & Biologics
How Feasible is Feasibility in Clinical Trials?
What is Steady-State Concentration in Pharmacokinetics?
Lessons Learned From a Phase II Influenza Clinical Trial
Tissue-Agnostic Therapeutics and Biomarkers in Oncology
9 Tips for Preparing a Successful New Drug Application (NDA)
What are Real-World Data and How Can they Benefit Drug Development?
Risk Evaluation and Mitigation Strategy: Tipping the Balance for FDA Approval
Getting your ducks in a row: Successful Management of Large eCTD Submissions
What is Allometric Scaling and How Does it Support Drug Development?
To the Rescue: A New Hope for Your Development Program
Completing a Rescue Study Transition - How Much Time Do You Need?
What is IVIVC?
Journal for Clinical Studies: Combination Approaches in Immuno-Oncology Trials: New Horizons for Multiple Tumor Indications
Mind the Gap(s): Early Identification of Issues is Key for a Successful NDA or BLA
Best Practices in Clinical Study Protocol Writing
Types of Marketing Exclusivity in Drug Development
What is a Human Mass Balance Study?
Importance of Natural History Studies to Rare Disease Drug Development
3 Rare Disease Challenges Overcome From A Recent Phase 3 Pivotal Study
5 Key Considerations Non-EU Based Sponsors must have for GDPR Compliance in Clinical Trials
Pharmacokinetics in Patients with Hepatic Impairment
Surrogate Endpoints – Neither the End nor the Point
How to Successfully Prepare for Your Pediatric Study Plan
Overview of immuno-oncology clinical trial conduct and design investigating combination therapies
What to Expect following Your Marketing Application Submission
New FDA Guidance on Natural History Studies for Rare Diseases
Dose Selection for Cellular and Gene Therapies
eCTD Regulatory Submissions: Hints & Common Mistakes to Avoid
Does the FDA Esketamine Approval Open the Door for Enrichment Trial Designs in Psychiatry?
Intrinsic and Extrinsic Factors in Drug Development
Let's Talk About Patient Engagement
Revised FDA Guidance on Developing Rare Disease Therapies
Pharmacogenetics - Tailoring Your Product to Fit the Genes
Draft Guidance of the Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
Pharmacokinetic Considerations for Topical Medications
New Year New FDA Strategic Framework on Real World Evidence Program
The Path to IND Part 2: Supporting Clinical Study Design and Dosing
What is Population Pharmacokinetic (popPK) Analysis?
The Path to IND Part 1: Milestones & Common Roadblocks
Journal for Clinical Studies editorial - Landscape of early-phase oncology studies in the Netherlands
Why Do Clinical Trials Fail?
What is the Difference Between ANDAs & 505(b)(2) NDAs?
Combination immunotherapy: The latest revolution in cancer treatment
What is Noncompartmental Pharmacokinetic Analysis?
What is Model-Informed Drug Development?
Metabolites: Formation, Identification, and Impact on Drug Development
What is the Difference Between PBPK and PopPK Modeling?
IND Requirements and Exemptions
New Meeting Opportunities with FDA through the Model-Informed Drug Development (MIDD) Pilot Program
Exception from Informed Consent in Emergency Research
Submitting IND Safety Reports using us-regional DTD v3.3 versus v2.01: What’s the Difference?
Understanding the Cost of Pharmacokinetic & Pharmacodynamic Analyses
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