Risk Based Quality Management

In this section

• Digital Disruption
  • AI and clinical trials
    • Impact of AI on Outcomes Based Contracting
    • Using AI for site ID and selection
    • Applying AI to manage the risks and costs of postmarketing requirements
  • Clinical trial data anonymisation and data sharing
  • Clinical Trial Tokenisation
  • Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
  • Digital disruption in biopharma
  • Disruptive Innovation
  • Remote Patient Monitoring
    • Bring Your Own Device
    • Cybersecurity
      • Addressing cybersecurity for your medical device
    • Digital Endpoints
    • Transforming Medical Device Development with mHealth
  • Personalising Digital Health
  • Real World Data
    • Harnessing technology to maximise Real World Evidence value
    • Meeting Evidentiary Needs with EHRs
    • Post-Market Surveillance for Medical Devices
  • The triad of trust: Navigating real-world healthcare data integration
• Patient Centricity
  • Agile Clinical Monitoring
  • Capturing the voice of the patient in clinical trials
  • Charting the Managed Access Program Landscape
  • Developing Nurse-Centric Medical Communications
  • Diversity and inclusion in clinical trials
    • Diversity and inclusion in clinical trials whitepaper
  • Exploring the patient perspective from different angles
  • Patient safety and pharmacovigilance
    • A guide to safety data migrations
    • Taking safety reporting to the next level with automation
    • Outsourced Pharmacovigilance Affiliate Solution
    • The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
    • Sponsor and CRO pharmacovigilance and safety alliances
    • Understanding the Periodic Benefit-Risk Evaluation Report
  • Patient voice survey
  • Patient Voice Survey - Decentralised and Hybrid Trials
  • Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
  • Using longitudinal qualitative research to capture the patient voice
• Regulatory Intelligence
  • An innovative approach to rare disease clinical development
  • EU Clinical Trials Regulation
    • EMA guideline on computerised systems and electronic data in clinical trials
    • EU CTR Whitepaper
  • Using innovative tools and lean writing processes to accelerate regulatory document writing
  • Current overview of data sharing within clinical trial transparency
  • Global Agency Meetings: A collaborative approach to drug development
  • Keeping the end in mind: key considerations for creating plain language summaries
  • Navigating orphan drug development from early phase to marketing authorisation
  • Procedural and regulatory know-how for China biotechs in the EU
  • RACE for Children Act
  • Early engagement and regulatory considerations for biotech
  • Regulatory Intelligence Newsletter
    • RAPS Subscribe
  • Requirements & strategy considerations within clinical trial transparency
  • Spotlight on regulatory reforms in China
  • Demystifying EU CTR, MDR and IVDR
  • Transfer of marketing authorisation
• Therapeutics insights
  • Endocrine and Metabolic Disorders
    • Obesity
      • Addressing obesity's impact across the disease spectrum
      • Trends and challenges in obesity research and clinical trials
  • Cardiovascular
    • Mitigating the impact of COVID-19 on cardiovascular trials
  • Cell and Gene Therapies
    • Approaching the CAR T-cell therapy horizon
    • Cell and Gene ebook
    • Long-term follow-up studies of cell and gene therapies
    • Mainstreaming Cell & Gene Therapies
  • Central Nervous System
    • A mind for digital therapeutics
    • Challenges and opportunities in traumatic brain injury clinical trials
    • Challenges and opportunities in Parkinson’s Disease clinical trials
    • Key Considerations in Chronic Pain Clinical Trials
  • Glycomics
  • Infectious Diseases
    • Antimicrobial Resistance
    • Considerations for strengthening vaccine development
    • COVID-19 vaccine trials
    • COVID-19 vaccines: Post-authorisation safety surveillance
    • HIV
    • The value of dynamic transmission models
  • NASH
    • The voice of NASH investigators
  • Oncology
    • ICON survey report: Innovation in Oncology
    • De-risking clinical development of precision medicines in oncology
    • Advances in imaging biomarkers: Estimating drug efficacy with tumour growth rate modelling
  • Paediatrics
    • Paediatric Risk Assessment Map
  • Respiratory
  • Rare and orphan diseases
    • Advanced therapies for rare diseases
    • Cross-border enrollment of rare disease patients
    • Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
    • Diversity, equity and inclusion in rare disease clinical trials
    • Identify and mitigate risks to rare disease clinical programmes
    • Leveraging historical data for use in rare disease trials
    • Natural history studies to improve drug development in rare diseases
    • Patient Centricity in Orphan Drug Development
    • The key to remarkable rare disease registries
    • Therapeutic spotlight: Precision medicine considerations in rare diseases
• Transforming Trials
  • Accelerating biotech innovation from discovery to commercialisation
  • Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
  • Linguistic validation of Clinical Outcomes Assessments
  • Optimising biotech funding
  • Adaptive clinical trials
    • Adaptive Design: The Faster Path to Market
  • Best practices to increase engagement with medical and scientific poster content
  • Decentralised clinical trials
    • Biopharma perspective: the promise of decentralised models and diversity in clinical trials
    • Decentralised and Hybrid clinical trials
    • Practical considerations in transitioning to hybrid or decentralised clinical trials
    • Navigating the regulatory labyrinth of technology in decentralised clinical trials
  • eCOA implementation
  • Blended solutions insights
    • Clinical trials in Japan: An enterprise growth and management strategy
    • How investments in supply of CRAs is better than competing with the demand for CRAs
    • The evolution of FSP: not just for large pharma
    • Embracing a blended operating model
  • Implications of COVID-19 on statistical design and analyses of clinical studies
  • Improving pharma R&D efficiency
  • Increasing Complexity and Declining ROI in Drug Development
  • Innovation in Clinical Trial Methodologies
  • Partnership insights
    • Exploring partnership culture and its impact on outsourcing and operational strategy
  • Risk Based Quality Management
  • Transforming the R&D Model to Sustain Growth
• Value Based Healthcare
  • Strategies for commercialising oncology treatments for young adults
  • US payers and PROs
  • Accelerated early clinical manufacturing
  • Cardiovascular Medical Devices
  • CMS Part D Price Negotiations: Is your drug on the list?
  • COVID-19 navigating global market access
  • Ensuring scientific rigor in external control arms
  • Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
  • Global Outcomes Benchmarking
  • Health technology assessment
  • Perspectives from US payers
  • ICER’s impact on payer decision making
  • Making Sense of the Biosimilars Market
  • Medical communications in early phase product development
  • Navigating the Challenges and Opportunities of Value Based Healthcare
  • Payer Reliance on ICER and Perceptions on Value Based Pricing
  • Payers Perspectives on Digital Therapeutics
  • Precision Medicine
  • RWE Generation Cross Sectional Studies and Medical Chart Review
  • Survey results: How to engage healthcare decision-makers
  • The affordability hurdle for gene therapies
  • The Role of ICER as an HTA Organisation
• Blog
• Videos
• Webinar Channel