Empowering Life Sciences Research: Digital Patient 360 Revolutionizes Clinical Data Management
Learn how organizations can accelerate innovation and progress in life sciences research and development.
By Arun Jayachandiran and Satya Kamarajugadda
In the constantly evolving landscape of life sciences research and development, the need for effective, adaptable, and regulatory-compliant clinical data platforms has never been more crucial. Built on the Databricks Data Intelligence Platform and recently launched as an official Databricks Brickbuilder solution, Digital Patient 360 is a transformative solution that aims to revolutionize and enable life sciences organizations to bring great value to patients faster than ever. In this blog post, we’ll explore the challenges faced by life sciences customers dealing with vast and diverse datasets and how Digital Patient 360 addresses these challenges to accelerate outcomes.
Key challenges facing life sciences organizations
Data volume and complexity
The volume and complexity of data in life sciences can be overwhelming. Data volumes of some of the complex datasets in this industry include omics (e.g., genomics), DICOM images, and sensor kits, which can range from gigabytes to terabytes. Extracting clinical data from medical imagery is difficult, let alone additional processing and analysis of images, because it can require extracting non-standard sources of metadata and it lacks annotations, etc. There are significant challenges in integrating and harmonizing diverse datasets due to varying data sources and data types. However, researchers need clean, consistent, linked multi-model data that can be used in understanding the connections between an individual’s health, disease patterns, and treatment outcomes.
Compliance and regulatory standards
The life sciences industry is subject to strict regulatory standards and compliance requirements to ensure patient safety and data integrity. Platforms need to meet regulatory standards such as good automated manufacturing practice (GAMP) for GxP. Compliance requires data provenance, traceability of requirements, data lineage, and other information to ensure the quality of data starting from the source through to publication.
Data security and privacy
Protecting sensitive patient data and ensuring privacy is paramount in the life sciences industry. Data needs to be secure, with encryption and access controls to safeguard patient confidentiality and comply with data protection regulations such as HIPAA for the US and GDPR for the EU. Privacy also includes the challenge of consent management and the ability to anonymize data for widespread use; in short, the need for secure, usable data without compromising patient security and identity.
Collaboration and data sharing
Life sciences research often involves collaboration among multiple stakeholders, including researchers, pharmaceutical companies, and healthcare providers. Successful collaboration requires knowing what data is in the inventory, understanding if there is enough data to meet the researchers’ needs, common standards of information, fine-grained data access controls, and the list goes on. Data platforms need to facilitate secure data sharing and collaboration, fostering a more interconnected and collaborative research ecosystem.
Reproducibility and transparency
Ensuring the reproducibility of research results is a significant concern in life sciences. Data needs version control, data lineage tracking, and documentation to enhance the transparency and reproducibility of research findings. Reproducibility and transparency are essential to meet the data quality and data integrity needs.
Enter Digital Patient 360: A solution built on the Databricks Data Intelligence Platform for accelerated clinical trials
Given the specific needs outlined above, many legacy data platforms have struggled to keep up with the complex landscape of specifications and regulatory requirements for clinical research. Leveraging our deep technical and industry expertise — including our recent partnership with a biopharmaceutical company establishing a new data lakehouse to support cutting-edge research into new and improved therapies for neurodegenerative diseases — Slalom created Digital Patient 360, a data platform with the ability to onboard diverse data types, consolidate data into a common model, aggregate data for a common patient-centric view, and display insights through user-friendly dashboards. Designed on robust lakehouse architecture on Databricks, Digital Patient 360 not only tackles the challenges of data integration, compliance, and security but also goes a step further by providing a configurable and user-friendly environment for clinical research teams to extract actionable insights from a wealth of clinical and genomic information, creating a complete picture of the patient journey.
A consolidated clinical data platform to accelerate research
Automated clinical data ingestion
Digital Patient 360 supports the ingestion of clinical data such as medical images, electronic health records, and wearables technology data and performs API calls to integrate with other data sources for data retrieval required for terminology standardization. This capability enables the seamless integration of different data types and interoperability needed for research purposes.
Templated workflow
Templated workflows enable the orchestration of multiple tasks with tied-in dependencies through code. This feature improves the time to create and provision workflows and eliminates manual interference during deployment into different environments. Deployment of workflows to different environments is made easy with deployment pipelines.
Common data model
Digital Patient 360 is equipped with a patient-centric data model that aligns with the Fast Healthcare Interoperability Resources (FHIR) standards. This model has different domains of the patients’ health information, and data coming from different data providers can be persisted in this model such that data is immediately usable for any users. This model allows for the construction of a participant’s journey, offering insight into a participant’s experience in a clinical study and providing visibility into the various stages and aspects of the participant’s engagement over time. Unified datasets enable precision medicine by identifying unique factors, optimizing treatment for better outcomes, fostering patient-centric care, and even accelerating medical discoveries. Such enhanced research collaboration increases the discovery probabilities significantly, shaping a future where healthcare is personalized, efficient, and collaborative.
Automated consent check, logging, and audit
Inbuilt consent checks, logging, and auditing mechanisms play a pivotal role in preserving privacy and data security. Automated consent checks ensure continual validation of user permissions for the usage of data for research purposes, establishing a secure and ethically grounded data environment. The logging feature records all interactions, promoting transparency and accountability throughout the system. Meanwhile, the audit function enhances the platform’s reliability by facilitating thorough reviews. Together, these features provide users with the confidence that their data is handled responsibly, adhering to ethical principles and regulatory expectations.
FAIR platform and security
Adhering to FAIR principles, Digital Patient 360 provides a centralized data catalog solution, improving machine actionability on data assets. A custom data catalog that only retains metadata of the data assets on the platform helps expose the data availability on the platform without exposing the data itself. Access to the underlying data assets is restricted to the owner of the data (e.g., study coordinator, principal investigator, clinical research associates, etc.) and users that the owner shares access with (e.g., academic researchers, regulators, etc.), thus aligning with the security requirements in such a regulated space.
Analytics, reporting, and clinical decision support
Given that Digital Patient 360 is built on the Databricks Platform, data-sharing through Delta Sharing, integrating with popular reporting tools such as Spotfire, Power BI, Quicksight, and Tableau, enables collaboration and insights through analytics.
Combined, these features and more result in a consolidated clinical data platform, exponentially decreasing the time needed to provision a data asset required for the research, thus improving the research times required for the development of new and improved therapies with real-world research network data.
Compliant, patient-centric innovation at speed
Compliance assurance
Organizations can ensure industry regulatory requirements and compliance standards are met with the ability to seamlessly manage patient consent and data privacy all in one platform.
Efficiency and innovation acceleration
On average, it takes 7–10 years to bring a drug to market, with regulatory administration activities accounting for about a third of the current clinical development time. By streamlining the data onboarding and analysis process, Digital Patient 360 significantly reduces the time spent loading and validating data, allowing clinical researchers to maximize time on critical activities.
Data quality
With observability and lineage built into the platform, Digital Patient 360 ensures transparency and compliance throughout the data lifecycle. This not only expedites the validation process but also instills confidence in the accuracy and reliability of the data for improved decision-making.
Versatility
The ability to analyze patient journeys and conduct studies and clinical trials all in one platform eliminates the effort of moving data to different places for different needs, and the results of the analysis can be published back into the platform to support other studies.
Conclusion
Digital Patient 360 stands at the forefront of revolutionizing clinical data management in the life sciences industry. By addressing the challenges associated with large volumes of diverse data, this platform empowers researchers to accelerate studies, streamline clinical trials, and contribute to the development of new and improved therapies. In a landscape where time is of the essence, Digital Patient 360 emerges as a catalyst for innovation and progress in biopharmaceutical research. Reach out to explore how Digital Patient 360 can propel your organization into a new era of data-driven discoveries and advancements.
Slalom is a global consulting firm that helps people and organizations dream bigger, move faster, and build better tomorrows for all. Learn more and reach out today.
