Newsletter | October 11, 2024

10.11.24 -- These 3 Areas Need Risk Management Attention Now

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Right-sized for biotech success

It’s not the size of your company. It’s the size of your passion and your dedication to improving patients’ lives that IQVIA Biotech is uniquely built to serve. There is nothing bigger to us than your success. We’ve got you.

TRIAL MONITORING

3 Areas Needing Risk Management Attention

Consultant Jessica Cordes and medical affairs expert Oscar Segurado discuss the three key areas of risk in clinical trials- Enrollment, Patient Retention, and Adverse Events.

Understanding How To Build And Leverage A DSMB Statistical Plan

Get an overview of the essential components involved in providing independent statistical center support for a data safety monitoring board (DSMB), also known as a data monitoring committee (DMC).

GxP Quality Assessment And Remediation

Ensure regulatory compliance and foster continuous improvement through the use of comprehensive GxP quality assessment and remediation services.

SPONSOR

With ICH M11 expected to be adopted by the end of the year, the next Clinical Leader Live digital event will host a panel discussion on the advantages of improving and simplifying the dataflow of clinical trials but also the challenges associated with creating a connected digital dataflow, including digital health channels, that spans from protocol to data collection to CSR. Register today and join us on 10/31 at 1 pm ET (10 am PT).

CLINICAL DATA MANAGEMENT & ANALYTICS

AI Can't Help Bad ClinOps/Health Equity Data

Brian Johnson, Ph.D., VP, R&D Technology at Takeda discusses the huge opportunity of connecting disparate ClinOps data and leveraging generative AI to reduce costs and labor during the clinical process. 

Streamlined Feasibility: Unlocking The Site-Sponsor Relationship

Determining the feasibility of a site for clinical research is a critical component of the entire trial process. Discover how automation and standardization can improve the site-sponsor journey.

Harnessing The Potential Of Patient-Level Data In Clinical Trials

Join our panel of industry leaders as they explore innovative methods and best practices for incorporating fully consented patient data in clinical trials.

Medical Affairs: Enhance And Expand Your Team's Impact

Medical affairs are vital, bridging pharma, professionals, and patients. Explore insights for navigating industry shifts, leveraging technology, and empowering professionals in this dynamic landscape.

Leveraging Large Language Models For Business Automation

Unlocking the full potential of Large Language Models (LLMs) for operational workflows requires strategic selection and meaningful prompts. Let’s explore their application in business automation.

How DP Clinical Leverages Medrio For Optimal Data Management

Matthew Jachowski, Senior Technical Clinical Data Manager, and Jim Hamer, Director of the Spinal Cord Injury Program, share valuable insights on the importance of flexible data capture solutions and robust clinical data management support.

Machine Learning To Drive Clinical Trial Efficiency

Read on as authors explore accessing real-time clinical trial data for proactive study management, using adverse event data to enhance safety and performance, and tools to improve design.

Parexel Principles For Artificial Intelligence

AI offers powerful tools to better manage clinical development. By leveraging AI, we can expedite development timelines, ensuring that new products reach patients more quickly.

EVENTS

Real-World Evidence Conference

October 24-25, 2024 | Philadelphia, PA
In a market that is constantly adapting and adjusting to the needs of the healthcare field, real-world evidence (RWE) is becoming increasingly important for regulatory and reimbursement decision-making. Historically used for post-market safety monitoring, RWE is now integrated throughout the product development lifecycle and has led to the real-time analysis of data to better understand and gain insights on disease, approaches to treatment, and how to substantiate coverage decisions. Learn More.

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You're receiving the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial Monitoring. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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