Powerful data management solutions from the clinic to commercial launch.

Organizations typically formalize their approach to data management as they transition from preclinical to clinical phases, around the time they begin Phase I trials. The entry into clinical trials is marked by increased regulatory scrutiny, data volume, and complexity. Data management is critical to ensuring that data collection, storage, and analysis processes are robust, compliant, and scalable. Establishing a validated data management system at this stage helps maintain data integrity, support regulatory submissions, and facilitate efficient data analysis. Strong Tower’s expertise in designing and implementing comprehensive data management systems ensures that your data processes are optimized for success from early development through to market launch.

Scientific organizations benefit most from data management tools that offer robust data orchestration, real-time analytics, and comprehensive data governance. Tools that facilitate seamless integration with Electronic Data Capture (EDC) systems, Laboratory Information Management Systems (LIMS), and Clinical Trial Management Systems (CTMS) are particularly valuable. Additionally, platforms that provide advanced features such as metadata management, automated data cleaning, and audit trails enhance data integrity and streamline compliance. Strong Tower offers a suite of validated data management tools tailored to the needs of clinical-stage therapeutics, ensuring that your data is accurate, traceable, and ready for regulatory scrutiny.

Proper data management ensures that data collected during clinical trials is accurate, complete, and compliant with regulatory requirements. This reduces the risk of delays caused by data discrepancies, regulatory non-compliance, or the need for re-collection of data.

In addition, efficient data management practices facilitate streamlined data processing and analysis, enabling quicker decision-making and more proactive identification of any issues that may arise during trials. Robust data governance frameworks ensure data integrity and traceability, which are essential for meeting regulatory standards and expediting the approval process. Furthermore, advanced data management systems provide real-time monitoring and reporting capabilities, allowing for proactive management and faster resolution of potential bottlenecks.

Strong Tower’s data management solutions are designed to expedite the journey to market by offering comprehensive data orchestration, rigorous validation processes, and secure data handling. By leveraging our expertise, clinical stage candidates can optimize their data management workflows, reduce time-to-market, and improve the overall efficiency of their clinical trials.

Organizations should look for data management solutions that provide scalability, flexibility, and robust security measures. Key features include comprehensive data governance frameworks, efficient data processing and analysis workflows, and the ability to handle diverse data types and sources. Solutions should also offer integration capabilities with existing systems, advanced analytics, and real-time reporting to support informed decision-making. Strong Tower’s data management solutions are designed to meet these criteria, offering customizable, validated systems, deep integration expertise, and an approach that significantly accelerates time-to-insight.

Strong Tower guarantees regulatory compliance by establishing thorough data governance frameworks aligned with industry standards like GxP, 21 CFR Part 11, and ICH guidelines. We perform stringent validation procedures, encompassing data, system, and process validation, to ensure all data management operations meet regulatory criteria. Our solutions offer comprehensive audit trails, real-time monitoring, and secure data handling methods, ensuring your data’s integrity and compliance throughout the clinical trial process.