Application Development And Data Management
CurrentAs a key contributor to the TrialPoint EDC platform, I design and implement innovative solutions that drive efficiency, accuracy, and patient engagement in clinical data management. My work spans across multiple areas, from AI-driven automation to mobile applications, with a focus on streamlining complex clinical processes and improving data quality.Key Areas of Expertise:AI & Automation Integration• Integrated AI models for document analysis to automate the import of paper case report forms (CRFs) into the EDC system, reducing manual effort and enhancing data accuracy.• Led the development of test automation solutions for EDC projects, optimizing workflows and minimizing errors.Clinical Data Management• Expertise in designing electronic case report forms (eCRFs) and clinical databases to ensure seamless data collection and integrity.• Implemented edit checks and managed processes such as data entry and verification, resolving data discrepancies, SAE reconciliation, database finalization, and database lock.Mobile & Patient-Reported Outcomes (ePRO)• Designed and developed a mobile ePRO (electronic Patient-Reported Outcomes) platform, improving the collection of patient-reported health outcomes and quality of life data directly from patients, ensuring better data quality and real-time insights.Device Accountability - Designed and developed a Device Accountability application, streamlining the tracking and management of investigational devices to ensure compliance with regulatory requirements and reduce operational complexity.Leadership & Support:• Provided ongoing support and training to clinical data associates, fostering skill development and enhancing team efficiency across multiple studies.• Worked closely with cross-functional teams to analyze and configure study protocols within the EDC system, ensuring alignment with study needs, regulatory standards, and best practices.