The Evolution of Data Management at Geneuity: Enhancing Clinical Trial Success
Effective data management is crucial in the fast-paced world of clinical trials. At MPLN, our journey through data management has evolved significantly since our first clinical trial in 2004. From the first iteration of our data services to establishing our current specialized and robust Data Management Team, we’ve made strides that improve efficiency and enhance the quality of our deliverables.
The Genesis of Data Management Services: A Specialized Approach
MPLN’s foundation as a CAP/CLIA/ISO15189 accredited clinical laboratory provided an ideal segway into the clinical research industry; our involvement in clinical trials began in 2004 with a specialized IVD study. Between 2004 and 2018, MPLN established and expanded our clinical research portfolio, branching into new biopharma spaces and evolving our services to fit their diverse needs. Because data is at the heart of what MPLN offers, it became abundantly clear that clinical trials require specialized data services beyond a universal approach. One size does not fit all data needs. With this forethought and the foundational know-how, we took our first steps toward building a robust data management framework to complement our expanding biopharma services.
Establishing a Specialized Team
In 2018, our first dedicated data specialist began the genesis of our Data Management team. This pivotal move enabled us to address the increasing volume of data-related requests and standardize processes. Additionally, it allowed us to better support the diverse range of clinical trials that MPLN now supports—from small IVD studies to phase 1-4 global research trials.
By 2022, our Data Management department expanded to include an additional Data Specialist capable of generating custom code, resulting in streamlined operations. The specialist also created structured data services with capabilities in scripted and automated database validations and quality checks. Our team continued to expand, and in 2023, we implemented a code review process to ensure accuracy, accountability, and redundancy in our data handling processes.
As our data management team continues to grow in 2024 and beyond, we are now well-equipped to meet our clients’ increasing demands while maintaining a strong focus on quality and detail.
Our Present Status: The Data Management Process
At the core of our data management strategy is the Data Transfer Agreement (DTA). This essential document outlines the specifics of data delivery, ensuring that MPLN and our clients are aligned on expectations. Key elements of the DTA include:
- Delivery Format: We tailor the data format to each client’s needs, ensuring all specifications are met.
- Transfer Method: We offer a secure web-based transfer platform managed and hosted by our dedicated teams.
- Data Security Specifications: Clients often require data to be encrypted or password-protected, a standard we support.
- File Naming Conventions: A clear file naming structure is established to streamline data identification.
- Version History: We maintain a comprehensive record of changes to the DTA, facilitating transparency and accountability.
The DTA is the constitution of our data contracts, guiding every aspect of data handling, from transfer methods to update frequency.
Ensuring Quality Through Rigorous Validation
Our data transfer process involves multiple validation layers to ensure that the data delivered meets the highest standards.
- Setup Validation: Quality control scripts are written to verify that the Laboratory Information System (LIS) data matches the required formats.
- Data QA Review: The source data and transferred data are compared during the initial and subsequent transfers.
- Data QC Checks: Checks using R scripts and SQL queries, promptly alerting the project services team to discrepancies.
Once a data file passes all quality checks, it is securely transferred according to the DTA specifications and logged for billing and internal purposes.
The Current Impact of MPLN/Geneuity’s Data Management Services
Ultimately, our data management efforts provide clients with efficient study content, high-quality data, regulatory compliance, accountability, scalability, cost savings, and a competitive advantage in the clinical trial landscape. Examples of how our data services have made a significant impact in the biopharma space include:
- Ongoing Safety Evaluation
Real-time report availability and close project management oversight play crucial roles in the ongoing assessment of patient safety when treated with innovative gene therapies. - Groundbreaking Research Publications
A recent study featured whole-slide digital images from the MPLN laboratory, paving the way for therapies targeting novel overexpressed biomarkers. - FDA Approval Success
Pathology data helped a major biopharma client secure FDA approval for a revolutionary treatment for Crohn’s Disease. - Pioneering Cancer Trials
Critical pathology data demonstrated the efficacy of a novel therapeutic in CLL and SLL, leading to new indications and driving improved patient outcomes. - Driving IVD Innovations
Molecular data has been pivotal in multiple IVD studies, leading to FDA approval of various assays in women’s health and infectious diseases.
As we continue to innovate and refine our data management processes, MPLN remains committed to delivering exceptional service to our clients and ensuring the success of their clinical trials.
