Client Background
Our Client Drives Innovation Through Advanced Analytics and Transformative Technology
Our client is a prominent player in the life sciences industry, providing comprehensive solutions that span advanced analytics, innovative technology, and clinical research services. The company leverages its extensive domain expertise and big data resources to forge intelligent connections across the healthcare spectrum. Through its transformative technology and analytics, the company empowers its customers to accelerate the development and commercialisation of medical treatments that enhance patient outcomes.
Challenge
Lack of Streamlined Data Management System for RWE Study
A leading pharmaceutical company wanted to conduct a prospective observational real-world evidence study to evaluate the effectiveness and safety of a nutritional supplement in patients who have undergone Coronary Artery Bypass Surgery (CABG). They approached our client to assist in setting up an Electronic Data Capture (EDC) system to facilitate and perform data management activities and statistical analysis.
Healthark’s role
Assisted in EDC Implementation, Robust Data Management & Statistical Analysis
Healthark supported the client in the development and testing of the patient identification algorithm through the following activities:
- EDC Setup We analyzed the study protocol to identify the data collection needs and then worked with the client to define and document the EDC system requirements. Collaborating with an EDC system provider, we helped design the system, created electronic data collection forms (eCRFs), and established validation rules with input from both the client and sponsor. The system configuration involved inputting data fields, customizing the interface, and setting user roles. Thorough testing and validation were performed to ensure the system met all requirements, and any issues were resolved before obtaining final approval from the CRO and sponsor.
- Site Training We prepared training materials and scheduled sessions, which included creating training manuals and guides and planning sessions for the site staff. Separate training sessions were conducted for each site, demonstrating data entry and query resolution processes, and live support was provided.
- Data Management We monitored the site staff’s entries and performed regular data validation checks to ensure accurate and complete data entry into the EDC system. Data queries were generated to address any discrepancies. Once the data was reviewed for completeness and accuracy and all outstanding queries were resolved, the database was locked.
- Data AnalysisWe extracted the data from the EDC system, maintaining data integrity throughout the process. Subsequently, statistical analysis was conducted, resulting in the generation of tables, listings, and summary reports. These findings were then interpreted to derive meaningful conclusions from the study.
Empowering Tomorrow's Healthcare
This case study showcases the transformative impact of advanced analytics and real-world data in enhancing patient outcomes. By streamlining data management and conducting robust statistical analysis, we empower our clients to accelerate medical innovations and make informed decisions for a healthier tomorrow.
Want to learn more about Healthark’s expertise in Real-World Evidence? Explore our website or contact us today!
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