Data Management
Data Management
The key to a successful clinical trial is accurate, clean, quality data. Our team of data specialists provides you with data in customized formats exported to your data management teams from our flexible in-house laboratory information system (LIS).
Key Features
- Efficient Study Conduct – Streamlined data collection, cleaning, and processing with access to real-time report delivery to aid patient management
- Data Quality – Accurate, consistent, and error-free data to meet your critical data transfer timelines
- Regulatory Compliance – Databases and processes are 21 CFR Part 11, GDPR, and ISO 15189 compliant
- Accountability – Audit trails available for clientsand regulatory authorities as needed
Benefits
- Flexibility – Customized reporting and data solutions are agreed upon during study setup in data transfer agreements
- Cost Savings – Minimized need for manual data entry and data QC due to automated process implementation
- Competitive Advantage – Leverages data assets to drive innovation, improve decision-making, and enhance patient safety
The Data Management Process:
The Data Transfer Agreement (DTA) is at the core of our data management strategy. This essential document outlines the specifics of data delivery, ensuring that both parties are aligned on expectations.
Key elements of the DTA:
- Delivery Format: We tailor the data format to match your needs, ensuring all specifications are met.
- Data Security: We adhere to any standard required for the study, whether data encryption, password protection, or safe file transfer processes (sFTP).
- File Naming Conventions: A clear file naming structure is established to streamline data identification.
- File Transfer Frequency: A calendar for all data transfers throughout the study’s duration is established upfront to comply with data lock requirements.
Data Quality Assurance Processes:
Our data management processes involve multiple layers of validation to ensure that the data delivered meets the highest standards.
- Setup Validation: Quality control scripts are written to verify that data from the Laboratory Information System (LIS) matches the required formats.
- Data QA Review: Comparison of source data and transferred data is conducted during the initial and subsequent transfers.
- Data QC Checks: Thorough checks using SQL queriesare performed, promptly alerting the project services team to any discrepancies prior to data delivery.
Once a data file passes all quality checks, it is securely transferred according to the DTA specifications.
The Impact of Geneuity’s Data Solutions: Innovation in Healthcare:
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 on the biopharma sector 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.
Our Data Management team excels in delivering real-world data that supports effective disease solutions, ensuring our clients remain at the forefront of healthcare advancements.
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