11.11.22 -- Takeda's 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.

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.

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

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

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.

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.

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.

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

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.

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.

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.