Blogs

Achieving Operational Excellence in Clinical Research Organizations: A Catalyst for Biotech Success
EU Pharmaceutical Legislation Reform - Towards a Resolution
Crossover Designs in Oncology: Statistical Perspectives
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
Exploring the Complexities of Healthcare-Associated Infections: Challenges and Insights
Sifting Through Rarity: Advanced Patient Screening for Rare Disease Trials
Mastering Clinical Trial Design: Will FDA’s Latest Guidance on Master Protocols Encourage Increased Adoption?
Fast-Tracking Drug Development: Role of Mechanistic PK/PD Modeling
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
Anti-Depression Medication: Current Landscape and Product Development Trends
Advancing Oncology Drug Development: The Importance of Single-Arm Trials
Inroads To Approval: Navigating Formal FDA Meetings to Optimize Your Drug Development Program
Exosomes: Unveiling Their Potential in Cell and Gene Therapy
Series on Cannabis and Cannabis-Derived Products for Therapeutic Development, Part One
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!
Overcoming Patient Recruitment Difficulties in Acute Ischemic Stroke Trials
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
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
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
What is Clinical Pharmacology?
Smarter Drug Development for Rare Diseases
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 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
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
Cervical Health Awareness Month - Cervical Cancer: Prevention, Detection, Development
Pharmacokinetic Parameters in Drug Development
Adaptive Design Considerations for Early Phase Oncology Trials
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
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
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
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
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
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
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 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
Immuno-Oncology Updates in the Virtual Era - ASCO 2020
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?
Clinical Research Regulation in the Netherlands
The Benefits of Conducting Clinical Research in Russia
Current Trends in Allergy 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
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?
DISCOVER 360: Allucent’s Comprehensive Approach to Site Selection
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
What are Adaptive Design Clinical Trials?
5 Common FDA Applications for Drugs & Biologics
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
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?
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
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
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
What Are CAR T-Cell Therapies?
Monoclonal Antibodies: Past, Present and Future
Bioequivalence Studies to Support Abbreviated New Drug Applications
Pharmacokinetic Considerations for Repeat-Dosing
Compassionate Use: providing cancer care outside trials
Cancer Immunotherapy: A New Hope
A New Expedited Review Designation: Regenerative Advanced Therapy
Transparency Initiatives at Health Canada
Precision Medicine and the FDA
CIMT 2016 - Rise of mRNA therapeutics, a relatively new class of treatment
CIMT 2016 "Mechanisms of efficacy in cancer immunotherapy"
Jump on the Development Safety Update Report (DSUR) Bandwagon!
The FDA Wants To Hear Patients’ Voices
PK/PD Analysis Potentially Eliminates the Need of a Thorough QT QTc Study
'Inhibit the inhibitor' - it's all about PD-(L)1 inhibitors in cancer treatment
Top Five Mistakes in Clinical Protocol Design