#Japan #Nagoya #PRiME-R #NTT Precision Medicine #Clinical Study Support

Enhancing Healthcare Research with Real World Data

In a significant move towards improving clinical research methodologies, Clinical Study Support, NTT Precision Medicine, and PRiME-R have entered into a partnership aimed at advancing the use of Real World Data (RWD) for generating actionable Real World Evidence (RWE). This collaboration will leverage the respective strengths of each organization to streamline and enhance the research process, ensuring that the data derived from real-world clinical settings is both robust and meticulously governed.

Partnership Overview

The partnership agreement centers on utilizing NTT Precision Medicine's Japan Precision Medicine Platform (JPP), which facilitates the effective aggregation and analysis of RWD from diverse medical institutions across Japan. Coupled with Clinical Study Support's extensive experience in clinical research, including study design and statistical analysis, and PRiME-R's expertise in registry data and clinical studies, this tripartite alliance is set to foster a comprehensive framework. This framework will guide researchers from study planning and execution through to data analysis and reporting, ensuring a cohesive and efficient approach to evidence generation.

Why This Partnership Matters

The growing focus on RWD in pharmaceutical development underscores the importance of real-world studies in validating and enhancing the efficiency of new medical therapies. With an increasing demand for high-quality evidence, the partnership seeks to address several challenges within the domain. These include the need for a solid operational infrastructure to facilitate research, assurance of data quality, and the ability to analyze and validate findings across multiple research facilities—requirements that are not easily met within traditional research frameworks.

The JPP serves as a critical infrastructure that provides researchers with a secure and comprehensive access point for diverse medical data, including clinical and genetic information. It allows for enhanced collaboration among stakeholders, making it easier for pharmaceutical companies and researchers to utilize the data seamlessly while adhering to stringent governance and security protocols.

Enhancing Research Capabilities

The agreement highlights each organization's strengths and roles:

• - Clinical Study Support (CSS):

- Provides comprehensive support throughout the entire research lifecycle, from study design to management, data handling, and reporting.

• - NTT Precision Medicine:

- Acts as the key facilitator for establishing a robust data utilization framework through its JPP.
- Offers technology, operational capabilities, and governance geared towards secure data handling.

• - PRiME-R:

- Focuses on constructing registries in collaboration with healthcare institutions while providing solutions to enhance the use of RWD in clinical studies.
- Aims to foster advancements in next-generation medicine through effective data utilization.

Anticipated Outcomes

The collaborative effort is expected to yield numerous benefits, including:

• - Expansion of use cases that encompass multi-site and diverse data sources, thereby enhancing opportunities for RWE creation.
• - Development of a structured approach that integrates operational, quality, and governance requirements from the planning stage, ultimately reducing lead times for research commencement.
• - Standardization of data management processes leading to improved research quality and reproducibility.
• - A flexible framework that can adapt to varying research needs from pharmaceutical companies and researchers, enhancing the support for clinical research and post-marketing surveillance.

Future Directions

The three organizations plan to prioritize high-need use cases based on feedback from pharmaceutical companies and academic researchers following the agreement. Their collective goal is to create a secure environment where stakeholders can confidently leverage RWD for healthcare advancements, ensuring a strong focus on research ethics, security, and data governance. The emphasis on creating a data-driven environment aims to propel the evolution of medical research and pharmaceutical development, benefiting patients and healthcare systems alike.

Closing Remarks

Due to this agreement, the integration of CSS's clinical research expertise with the capabilities of JPP and PRiME-R is expected to revolutionize the research landscape. By collaborating closely, the three organizations will work diligently to fulfill the growing evidence demands of clinical practitioners and researchers, delivering high-quality evidence with transparency and speed.

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For further inquiries regarding the partnership or its implications for future research, stakeholders can contact the respective organizations directly via their established communication channels.