Newsletter | November 10, 2022

11.11.22 -- Takeda's Strategic Approach To TMF


Welcome to the Friday edition of the Clinical Leader newsletter, focusing on Clinical Data Management & Analytics and Trial MonitoringUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
Trial Monitoring
Takeda Takes A Strategic Approach To TMF

Over the past five years, Takeda has been perfecting its all-in model for TMF, where both Takeda and its CRO partners collaborate in Takeda's eTMF. This enables transparency into TMF health across the partnership and drives more effective, proactive collaboration.

Is Oversight A Burden Or Pivotal To Operational Efficiency?

Learn about the forthcoming ICH E8 (R1) and ICH E6 (R3) guidelines that focus on quality by design (QbD) to gain efficiencies in conducting clinical trials, significantly impacting oversight.

Optimize Transparency, Communication, And Reporting For Patient Safety

Find global safety and pharmacovigilance solutions throughout the drug life cycle by optimizing transparency, communication, and audit-ready reporting.

How Can You Transform Clinical Trial Development?

Is siloed, lagging data slowing down your trial analyses and reporting? Turn data into knowledge in real time.


Clinical Data Management & Analytics
FDA Releases Final Guidance On RWD/RWE Submissions For Drugs And Biologics

The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.

Readying Your Clinical Trial For Linkage With Real-World Data

Discover why the near ubiquity of real-world data (RWD) sources has prompted sponsors to consider RWD’s role in study programs and regulatory bodies to issue guidance on their use in clinical development.

Digital Endpoints Of Gait And Balance In The Real World

Explore how recent advancements in wearable sensors and data science have provided the opportunities for objective and unobtrusive assessment of walking in the real world.

Overcoming Clinical Data Aggregation Challenges

Learn about typical relational database structures and why they don’t work for clinical analytics as well as the ideal clinical data aggregation solutions for continuous, automatic data consolidation.

How Can Sponsors And CROs Execute SDTM Faster With Lower Costs?

How can sponsors ensure study data tabulation model (SDTM) compliance while still maintaining the efficiency and speed necessary to meet their trial timelines and milestones?

The Case For A Clinical Data Strategy

Many companies are seeking to transform their methods to become data-driven organizations with digital health initiatives, which requires an organizational approach and vision around data strategy.

Clinical Trial Biometrics

Our industry-leading clinical analytics experts build tools and solutions that efficiently facilitate data management and biometrics activities by automating and applying advancing services and technologies.

Data Management Helps You See The Insights Beyond The Numbers

The IQVIA Clinical Data Repository (CDR) ingests, integrates, and standardizes data to drive downstream processes such as real-time data cleaning, decentralized trails, and centralized monitoring.