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- Category: Clinical Research
- Expert Interpretation and Analysis of Regulatory Intelligence Are Key to FSP-Delivered Pharmacovigilance
- FSP Flex Hub Teams Maximize Efficiency Across Lifecycle Maintenance
- Advancing New Treatments for Alopecia Areata
- The Power of Bespoke Hybrid FSP/FSO Solutions
- FSP Engagements Continue to Gain Popularity, Drive Success
- Dedicated Roles Keep FSP Projects on Schedule
- Proactively Manage Central Lab Studies with a Powerful New Dashboard
- Five Predictions for the Biopharma and Biotech Industries in 2024
- Getting the Pulse on Biopharma and Biotech Companies: Differing Perspectives on Clinical Development
- The Evolution of Adaptive Protocols: Early Clinical Development
- Six Factors for Biotech Companies to Consider When Choosing Next-Generation Contract GMP/CMC Laboratories
- Tokenization: Leveraging Patient Health Data to Improve Care in a Meaningful, Sustainable Way
- Informed Design of Bioanalytical PCR Assay Testing Parameters
- Survey Uncovers Global Challenges and Opportunities in Drug Development
- New Report Reveals Trends, Opportunities in Drug Development
- What’s Next for HIV Clinical Trials
- Seven Strategies to Avoid Common Pitfalls in Vaccine Development
- Relieve Caregiver Burden, Improve Neurodegenerative Clinical Trials
- Top 5 Challenges and Opportunities Drug Developers Face in Executing Clinical Trials
- The Year Ahead: Six Predictions for the Biopharma and Biotech Industries in 2023
- Strategies to Accelerate Clinical Research During a Public Health Emergency
- Global Differences and Sentiments About the Drug Development Industry
- Five Challenges and Solutions in mRNA Vaccine Manufacturing
- Survey: The Top 5 Innovations, Strategies and Technologies in Pharmaceutical R&D
- Report: R&D Trends in the Pharma and Biotech Industry
- Getting Ahead in mRNA Vaccine Development with an Experienced CRO Partner
- The Present and Future of Conditional Regulatory Authorization and Access Pathways for Cell and Gene Therapies
- The Complementary Roles of Wearables and Patient-Reported Outcomes in Patient-Focused Drug Development: Spotlight on Oncology Trials
- Four Key Attributes of Contract Chemistry Manufacturing and Controls (CMC) Labs
- A Letter to Our Customers Regarding the Crisis in Eastern Europe
- Why Use Liquid Chromatography-Mass Spectrometry in Drug Discovery and Development?
- Predicting Extractables & Leachables Amounts Using Mathematical Modeling
- The Benefits of Glucose Clamp Procedures in Clinical Trials
- Cell and Gene Therapy Lesson 4: Undefined Methodologies, Unstable Technology and Potential Challenges in the GMP Regulatory Environment
- The Challenges of Immuno-Oncology Combined Clinical Development, Part IV
- The Challenges of Immuno-Oncology Clinical Development, Part III
- The Challenges of Immuno-Oncology Clinical Development, Part II
- The Challenges of Immuno-Oncology Clinical Development, Part I
- Solid Phase Extraction: Realizing the Advantages of an Underutilized Technique
- Category: Clinical Trial Design
- Five Strategies to Tailor Your Pediatric Clinical Trials to the Child’s Needs
- Emerging Trends in Clinical Trial Design
- How the Ongoing Digital Revolution Is Transforming Clinical Trial Design
- The Growing Role of CROs in Clinical Trials
- How Our New Implementation Lead Role Streamlines Onboarding Efficiency for FSP Projects
- Closing the Gender Gap in Clinical Research
- The Importance of Patient Diversity in Clinical Trials
- The Value of Patient Experience Data
- Estimands in Oncology Trials
- Five Key Decision Points That Set You Up for Commercial Success
- The Practical Applications of Modeling and Simulation
- Challenges With Uptake of Your Product? Implementation Science Could Be the Answer
- Leveraging Decentralized Real-World Evidence (RWE) Data Collection Strategies During the COVID-19 Pandemic and Beyond
- Overcoming Barriers to Large Global Studies: Cardiovascular Outcomes and Vaccine Trial Leaders on Research Methods That Made a Difference
- Mitigating Impacts of a Global Pandemic in the Clinical Development Space
- Regulatory Insights: Adaptive Clinical Trial Design – Overview and Critical Success Factors
- Implementing the Estimands Framework in Clinical Trials
- The Top Seven Things to Understand About Data Monitoring Committees
- Why Payer Perspectives Should Be On Your Radar Now–Even If Your Launch Is Years Away
- What’s on the Horizon for Oncology?
- Patient Engagement in Clinical Trial Protocol Design and Recruitment Strategies
- Category: Clinical Trial Management
- How to Fast-Track Clinical Research Timelines
- A Look Back as the EU Clinical Trial Regulation Moves Forward
- Ensuring Your Organization is Prepared for the Implementation of the EU Clinical Trial Regulation
- Five Qualities of a Specialized Medical Communications Partner
- Three Keys to Realize a Real-Time Data Ecosystem in Clinical Research
- Addressing Site Issues in Near Real-Time
- From Vendor to Partner: The Path to Selecting an Equally Devoted CRO
- Three Important Considerations in Operationalizing Nonalcoholic Steatohepatitis (NASH) Global Trials
- European Union Clinical Trials Regulation: Clinical Trials Information System
- Proactive Project Management
- COVID Elucidates the Need for Pregnancy Safety Studies
- Integrating Patient Preferences Into Health Technology Assessment: Five Steps to Success
- Key Considerations for Successfully Planning a Submission
- Technology and Innovations to Refine Site Contracting Processes
- RACE Act: A Promising Catalyst for Improved Pediatric Cancer Treatments
- Moderna Completes Enrollment of Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273)
- Why PPD’s Global Clinical Supply Functional Service is the Right Choice to Navigate Your Trials Through Brexit
- Our Solution to the Business Process Management Tool Needed to Maximize the Use of a Safety Database
- Understanding New Pharmaceutical Regulation as We Countdown to Brexit
- Enhancing Communication Between Clinical Trial Sites and the Central Lab During a Global Pandemic
- Moderna Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins
- Regulatory Insights: Focus on China — New Provisions for Drug Registration in 2020
- The Future of Clinical Research: Digitally Transforming What’s Possible
- Regulatory Affairs: Mitigating COVID-19’s Impact on Clinical Trials
- Cell and Gene Therapy Lesson 5: Lab Concierge – Extreme Focus on the Rare Disease Patient and Precious Study Sample Logistics Through an Innovative Lab Concierge Program
- Responding to COVID-19 Continuity Challenges
- Successfully Managing Change in Your Pharmacovigilance System
- Successful Partnering in Pharmacovigilance For Clinical Trials
- Reinforcing A Shared Mindset With Our Clients At PPD Biotech University
- How Infrastructure Design is Key to Enhanced Clinical Trials Data Management
- The Do’s and Don’ts of Randomization in Clinical Trials
- How Artificial Intelligence and Machine Learning Will Help Us Grow
- A Practical Guide For IMP Supply Chain Planning Post-Brexit
- Managing Clinical Studies Through European Holidays
- Brexit’s Potential Regulatory Impact on the Pharmaceutical Industry
- Bringing SDTM Alive for Monitoring and Review
- Three Key Areas for Today’s Project Manager in Clinical Trials
- Category: Data Management & Technology
- Clinical Data Management: The Past, Present and Future
- Five Pivotal Moments That Make or Break Your Clinical Trial
- Three Ways to Drive Vaccine Trials Through Integrated Clinical Development and Laboratory Services
- 360-Degree Data Capture Has Potential to Revolutionize Patient Care
- Real-World Data’s Role in Solving for Diversity in Clinical Research
- When it Comes to Diversity in Clinical Trials, Big Data is a Big Deal
- How the Pandemic Emphasized the Importance of Real-World Data
- Advancing Decentralized Trials in Oncology
- Spearheading the Fight Against Infectious Diseases and Emerging Outbreaks
- The Biggest Problems We Face Fighting Infectious Diseases
- Establishing a Microbiology Program and Custom Preclarus® Bacteriology Module within PPD® Laboratories Central Lab to Meet the Needs of Unique Customer Programs
- FDA Launches Digital Health Center of Excellence
- PPD’s Patient Data Dashboard: Moving Data Review Forward Today and Beyond
- How COVID-19 is Changing the Approach for the Vaccine Development Process
- Regulatory Insights: Virtual Trials Gaining Traction in the EU
- Regulatory Insights: Pandemic Speeds Adoption of Telemedicine in Clinical Trials
- Regulatory Insights: COVID-19 and its Impact on the Regulatory Affairs Landscape
- Reducing Patient Burden and Trial Complexity
- Balancing Scientific Value and Identification Risk in Anonymization
- Category: Digital/Decentralized Trials
- Category: Drug Commercialization
- Category: Early Drug Development
- Category: FSP
- Efficient Outsourcing: How Global Resourcing Drives FSP Success
- How to Harness the Follow-the-Sun Model in Your FSP Engagement
- How to Extend FSP Models Into Non-Footprint Countries
- The Art of Recruitment and Talent Development in FSPs
- Three Key Pillars for a Bespoke Recruitment Strategy for FSP Partnerships
- How an FSP Model Can Ensure Business Continuity During a Business Disruption
- How to Optimize Drug Development by Combining FSO and FSP Models
- Four Considerations When Selecting an FSP Partner
- Five Benefits of a Dedicated Operations Lead for FSP Engagements
- How to Keep Studies on Time and Budget Amid CRA Talent Shortages
- Case Studies: Three Ways Clients Have Found Success With the FSP Model
- An Overview of Clinical Trial Outsourcing Models — And How to Choose the Right One for Your Trial and Marketed Products
- Regulatory and Legal Insights on Rebadging
- Advantages and Considerations for Common Regulatory Outsourcing Models
- Strategically Selecting the Right Outsourcing Model for Drug Development — Considerations for Emerging Biotech
- Using Technology to Overcome Resourcing Challenges
- Outsourcing from a Pharmacovigilance Perspective
- Innovating: A Team of Teams Spproach at CROs
- Category: Innovation & What’s Next
- The Next Generation of Vaccine Mega Trials
- A New Look for the PPD Clinical Research Business
- Three Financial Conversations Biotech Leaders Need to Have in 2024
- How to Design Trials That Increase Patient Diversity Across Study Phases
- Can Your CRO Add Value During a Recession?
- Three Financial Shifts Biotech Leaders Need to Know for 2023
- Three Ways Patients and Advocates Can Inform Rare Disease Trials
- Six Trends Influencing the Future of Real-World Evidence
- The Story Behind How PPD® Laboratory Services Created a Method to Compare COVID-19 Vaccine Candidates
- Clinical Research is Growing More Complex; Build a Workforce That Can Handle It
- Category: Laboratories
- Get Prepared for New Plastic Packaging and Manufacturing Materials Requirements
- Understanding Extractables and Leachables Testing and Analysis
- How to Create the Contract Lab of the Future
- The Use of Bioanalytical Testing in Biosimilar Approvals
- Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study
- Virtual Lab Quality Audits: Are They Here to Stay?
- GTMP Sector Searches for Capacity and Experience To Bring Medicinal Products To Market
- Cell and Gene Therapy Lesson 1: Acronyms, Buzzwords and Crucial Lingo
- Cell and Gene Therapy Lesson 3: A Developing, Growing and Changing Regulatory Landscape
- Our Fight Against Tuberculosis: Clinical Trials With Experienced Teams
- Charting A New Course: Extractable and Leachable Testing
- Experiences at the 11th Workshop on Recent Issues in Bioanalysis (WRIB)
- Category: Oncology
- Category: Patient Centricity
- Seven Strategies to Increase Patient Diversity in Dermatology Clinical Trials
- The Value of Patient-Designed Clinical Trial Concierge Service
- How to Put the Patient First in Atopic Dermatitis Clinical Trials
- How to Prioritize Pediatric Populations in NASH Trials
- Keys to Success in Vaccine Development for Special Populations
- Five Medical Communication Preferences, According to Patients
- A Drug Development Guide for Cell and Gene Therapies
- The Power of Item Banks to Address Measurement Challenges in Patient-Reported Outcomes
- Educating and Enabling Physicians to Access Clinical Trials for Their Patients
- The Personal Impact of Rare Diseases
- Category: Patient Recruitment & Site Selection
- Category: Public Health
- Fast-Tracking Pediatric Development Plans for COVID-19 Vaccines and Treatments
- Take a Moment and Reconnect
- Devices/Diagnostics: Emergency Use Authorizations During the COVID-19 Pandemic
- The Critical Need for Pregnancy Registry Studies and Robust Safety Monitoring in COVID-19 Vaccines
- Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S.
- PPD Heroes: Advocating for the Patient’s Voice During COVID-19
- Using a Medical Monitoring Team to Overcome Challenges of COVID-19
- Regulatory Insights: Flexible Regulatory Pathways Accelerating Access to COVID-19 Treatments
- Regulatory Insights: New and Existing U.S. Expedited Development and Emergency Use Pathways for COVID-19 Programs
- World AIDS Day
- Category: Rare Disease
- Category: Real-World Data
- Category: Regulatory & Safety
- Success Factors for eCTD Implementation in Mainland China and Taiwan
- New European Union Regulation to Change How Clinical Trials are Conducted
- Regulatory Post-Approval Change Management in China
- How to Ensure a Successful Regulatory Submission
- EU Clinical Trial Regulation: Investigational Medicinal Product Labeling
- Moving Toward the Implementation Deadline – Approaching MDR Compliance
- Prepare Now for EU Clinical Trial Regulation Go-Live Date
- New and Emerging Regulatory Guidance for Cell and Gene Therapy Product Development
- Time to Act is Now: Paediatrics Medicines Development in the UK
- Regulatory Insights: ‘Right First Time’ Approach to Post-Authorization Strategy
- Regulatory Insights: Regulatory Intelligence Informs Sound Clinical Trial Strategy
- The Future of The Local Regulatory Affiliate: Adjusting To Global Strategies, Processes and Expectations
- Positive Changes in the Latin American Clinical Trial Regulatory Environment
- Seeking Ways to Ensure Participant Safety in First-in-Human Trials
- Major Clinical Trial Reforms Underway in China’s Regulatory Environment
- Category: Therapeutics