Leveraging Automation in Toxicology Data Ingestion Systems: A Case Study on Streamlining SDTM and CDISC Compliance
Main Article Content
Abstract
Toxicology studies play a critical role in ensuring the safety of pharmaceutical products, yet the process of ingesting and managing toxicology data for regulatory submission often remains labor-intensive and error-prone. This paper explores the application of automation in toxicology data ingestion systems to streamline the preparation of datasets compliant with the Study Data Tabulation Model (SDTM) and Clinical Data Interchange Standards Consortium (CDISC) guidelines. Through a detailed case study, we demonstrate how leveraging automation tools and workflows enhances efficiency, accuracy, and compliance in toxicology data management.
Our approach integrates robotic process automation (RPA), machine learning (ML), and rule-based systems to automate repetitive tasks, such as data extraction, transformation, validation, and mapping to SDTM formats. The proposed system significantly reduces manual effort, accelerates data preparation timelines, and minimizes errors, ensuring adherence to CDISC standards. Additionally, we examine key challenges, including data heterogeneity and interoperability issues, and propose scalable solutions for managing these complexities.
The case study highlights measurable benefits, such as a 40% reduction in data preparation time and improved accuracy in mapping datasets. Furthermore, the automated system facilitates real-time data tracking, enhances traceability, and provides audit-ready documentation, which are crucial for regulatory submissions. By adopting automation, organizations can optimize their toxicology workflows, align with industry standards, and focus resources on critical analysis rather than administrative tasks. This paper underscores the transformative potential of automation in advancing the efficiency and reliability of toxicology data management systems
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References
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• Shachi Ghanshyam Sayata, Priyank Mohan, Rahul Arulkumaran, Om Goel, Dr. Lalit Kumar, Prof. (Dr.) Arpit Jain. The Use of PowerBI and MATLAB for Financial Product Prototyping and Testing. Iconic Research And Engineering Journals Volume 7 Issue 3 2023 Page 635-664.
• Krishnamurthy, Satish, Nanda Kishore Gannamneni, Rakesh Jena, Raghav Agarwal, Sangeet Vashishtha, and Shalu Jain. “Real-Time Data Streaming for Improved Decision-Making in Retail Technology.” International Journal of Computer Science and Engineering 12(2):517–544.
• Mahaveer Siddagoni Bikshapathi, Sandhyarani Ganipaneni, Sivaprasad Nadukuru, Om Goel, Niharika Singh, and Prof. (Dr.) Arpit Jain. 2023. "Leveraging Agile and TDD Methodologies in Embedded Software Development." Iconic Research And Engineering Journals Volume 7 Issue 3, 457-477.
• Rajkumar Kyadasu, Sandhyarani Ganipaneni, Sivaprasad Nadukuru, Om Goel, Niharika Singh, and Prof. (Dr.) Arpit Jain. 2023. "Leveraging Kubernetes for Scalable Data Processing and Automation in Cloud DevOps." Iconic Research And Engineering Journals Volume 7 Issue 3, 546-571.
• Hrishikesh Rajesh Mane, Vanitha Sivasankaran Balasubramaniam, Ravi Kiran Pagidi, Dr. S P Singh, Prof. (Dr.) Sandeep Kumar, Shalu Jain. 2023. "Optimizing User and Developer Experiences with Nx Monorepo Structures." Iconic Research And Engineering Journals Volume 7 Issue 3, 572-595.
• Krishnamurthy, Satish, Abhijeet Bajaj, Priyank Mohan, Punit Goel, Satendra Pal Singh, and Arpit Jain. “Microservices Architecture in Cloud-Native Retail Solutions: Benefits and Challenges.” International Journal of Research in Modern Engineering and Emerging Technology (IJRMEET) 11(8):21. Retrieved October 17, 2024 (https://www.ijrmeet.org).
• Krishnamurthy, Satish, Ramya Ramachandran, Imran Khan, Om Goel, Prof. (Dr.) Arpit Jain, and Dr. Lalit Kumar. “Developing Scalable Recommendation Engines Using AI For E-Commerce Growth.” International Journal of Current Science 13(4):594.
• Rohan Viswanatha Prasad, Arth Dave, Rahul Arulkumaran, Om Goel, Dr. Lalit Kumar, Prof. (Dr.) Arpit Jain. 2023. "Integrating Secure Authentication Across Distributed Systems." Iconic Research And Engineering Journals Volume 7 Issue 3, Pages 498–516.
• Antony Satya Vivek Vardhan Akisetty, Ashish Kumar, Murali Mohana Krishna Dandu, Prof. (Dr.) Punit Goel, Prof. (Dr.) Arpit Jain; Er. Aman Shrivastav. 2023. "Automating ETL Workflows with CI/CD Pipelines for Machine Learning Applications." Iconic Research And Engineering Journals Volume 7 Issue 3, Pages 478–497.
• Rafa Abdul, Aravind Ayyagari, Krishna Kishor Tirupati, Prof. (Dr.) Sandeep Kumar, Prof. (Dr.) MSR Prasad, Prof. (Dr.) Sangeet Vashishtha. 2023. "Automating Change Management Processes for Improved Efficiency in PLM Systems." Iconic Research And Engineering Journals Volume 7 Issue 3, Pages 517–545.
• Gaikwad, Akshay, Srikanthudu Avancha, Vijay Bhasker Reddy Bhimanapati, Om Goel, Niharika Singh, and Raghav Agarwal. “Predictive Maintenance Strategies for Prolonging Lifespan of Electromechanical Components.” International Journal of Computer Science and Engineering (IJCSE) 12(2):323–372. ISSN (P): 2278–9960; ISSN (E): 2278–9979. © IASET.
• Dharuman, Narrain Prithvi, Aravind Sundeep Musunuri, Viharika Bhimanapati, S. P. Singh, Om Goel, and Shalu Jain. “The Role of Virtual Platforms in Early Firmware Development.” International Journal of Computer Science and Engineering (IJCSE) 12(2):295–322. https://doi.org/ISSN2278–9960.
• Gaikwad, Akshay, Dasaiah Pakanati, Dignesh Kumar Khatri, Om Goel, Dr. Lalit Kumar, and Prof. Dr. Arpit Jain. “Reliability Estimation and Lifecycle Assessment of Electronics in Extreme Conditions.” International Research Journal of Modernization in Engineering, Technology, and Science 6(8):3119. Retrieved October 24, 2024 (https://www.irjmets.com).
• Dharuman, Narrain Prithvi, Srikanthudu Avancha, Vijay Bhasker Reddy Bhimanapati, Om Goel, Niharika Singh, and Raghav Agarwal. “Multi Controller Base Station Architecture for Efficient 2G 3G Network Operations.” International Journal of Research in Modern Engineering and Emerging Technology 12(10):106. ISSN: 2320-6586. Online International, Refereed, Peer-Reviewed & Indexed Monthly Journal. www.ijrmeet.org
• Tirupathi, Rajesh, Sneha Aravind, Hemant Singh Sengar, Lalit Kumar, Satendra Pal Singh, and Punit Goel. 2023. Integrating AI and Data Analytics in SAP S/4 HANA for Enhanced Business Intelligence. International Journal of Computer Science and Engineering (IJCSE) 12(1):1–24.
• Tirupathi, Rajesh, Ashish Kumar, Srinivasulu Harshavardhan Kendyala, Om Goel, Raghav Agarwal, and Shalu Jain. 2023. Automating SAP Data Migration with Predictive Models for Higher Data Quality. International Journal of Research in Modern Engineering and Emerging Technology (IJRMEET) 11(8):69.
• Tirupathi, Rajesh, Sneha Aravind, Ashish Kumar, Satendra Pal Singh, Om Goel, and Punit Goel. 2023. Improving Efficiency in SAP EPPM Through AI-Driven Resource Allocation Strategies. International Journal of Current Science (IJCSPUB) 13(4):572.
• Das, Abhishek, Abhijeet Bajaj, Priyank Mohan, Punit Goel, Satendra Pal Singh, and Arpit Jain. 2023. Scalable Solutions for Real-Time Machine Learning Inference in Multi-Tenant Platforms. International Journal of Computer Science and Engineering (IJCSE) 12(2):493–516.
• Das, Abhishek, Ramya Ramachandran, Imran Khan, Om Goel, Arpit Jain, and Lalit Kumar. 2023. GDPR Compliance Resolution Techniques for Petabyte-Scale Data Systems. International Journal of Research in Modern Engineering and Emerging Technology (IJRMEET) 11(8):95.
• Das, Abhishek, Balachandar Ramalingam, Hemant Singh Sengar, Lalit Kumar, Satendra Pal Singh, and Punit Goel. 2023. Designing Distributed Systems for On-Demand Scoring and Prediction Services. International Journal of Current Science 13(4):514.
• Das, Abhishek, Srinivasulu Harshavardhan Kendyala, Ashish Kumar, Om Goel, Raghav Agarwal, and Shalu Jain. 2023. Architecting Cloud-Native Solutions for Large Language Models in Real-Time Applications. International Journal of Worldwide Engineering Research 2(7):1-17.
• 2. Kendyala, Srinivasulu Harshavardhan, Ashvini Byri, Ashish Kumar, Satendra Pal Singh, Om Goel, and Punit Goel. (2023). Implementing Adaptive Authentication Using Risk-Based Analysis in Federated Systems. International Journal of Computer Science and Engineering, 12(2): 401–430.
Kendyala, Srinivasulu Harshavardhan, Archit Joshi, Indra Reddy Mallela, Satendra Pal Singh, Shalu Jain, and Om Goel. (2023). High Availability Strategies for Identity Access Management Systems in Large Enterprises. International Journal of Current Science, 13(4): 544. doi:10.IJCSP23D1176.
Ramachandran, Ramya, Satish Vadlamani, Ashish Kumar, Om Goel, Raghav Agarwal, and Shalu Jain. (2023). Data Migration Strategies for Seamless ERP System Upgrades. International Journal of Computer Science and Engineering (IJCSE), 12(2): 431–462.
Ramachandran, Ramya, Nishit Agarwal, Shyamakrishna Siddharth Chamarthy, Om Goel, Punit Goel, and Arpit Jain. (2023). Best Practices for Agile Project Management in ERP Implementations. International Journal of Current Science (IJCSPUB), 13(4): 499.
Ramalingam, Balachandar, Satish Vadlamani, Ashish Kumar, Om Goel, Raghav Agarwal, and Shalu Jain. (2023). Implementing Digital Product Threads for Seamless Data Connectivity across the Product Lifecycle. International Journal of Computer Science and Engineering (IJCSE), 12(2): 463–492.
Ramalingam, Balachandar, Nishit Agarwal, Shyamakrishna Siddharth Chamarthy, Om Goel, Punit Goel, and Arpit Jain. (2023). Utilizing Generative AI for Design Automation in Product Development. International Journal of Current Science (IJCSPUB), 13(4): 558. doi:10.12345/IJCSP23D1177.
• Vanitha Sivasankaran Balasubramaniam, Siddhey Mahadik, Md Abul Khair, Om Goel, & Prof.(Dr.) Arpit Jain. (2023). Effective Risk Mitigation Strategies in Digital Project Management. Innovative Research Thoughts, 9(1), 538–567. https://doi.org/10.36676/irt.v9.i1.1500
• Sengar, Hemant Singh, Nanda Kishore Gannamneni, Bipin Gajbhiye, Prof. (Dr.) Sangeet Vashishtha, Raghav Agarwal, and Shalu Jain. 2024. Designing Scalable Data Warehouse Architectures for Real-Time Financial Reporting. International Journal of Worldwide Engineering Research 2(6):76–94. doi: [Impact Factor 5.212]. (https://www.ijwer.com).
• Rajesh Tirupathi, Abhijeet Bajaj, Priyank Mohan, Prof.(Dr) Punit Goel, Dr Satendra Pal Singh, & Prof.(Dr.) Arpit Jain. (2024). Optimizing SAP Project Systems (PS) for Agile Project Management. Darpan International Research Analysis, 12(3), 978–1006. https://doi.org/10.36676/dira.v12.i3.138
• Siddagoni Bikshapathi, Mahaveer, Ashish Kumar, Murali Mohana Krishna Dandu, Punit Goel, Arpit Jain, and Aman Shrivastav. 2024. "Implementation of ACPI Protocols for Windows on ARM Systems Using I2C SMBus." International Journal of Research in Modern Engineering and Emerging Technology 12(5): 68-78. ISSN: 2320-6586. Retrieved from www.ijrmeet.org.
• Bikshapathi, M. S., Dave, A., Arulkumaran, R., Goel, O., Kumar, D. L., & Jain, P. A. 2024. "Optimizing Thermal Printer Performance with On-Time RTOS for Industrial Applications." Journal of Quantum Science and Technology (JQST), 1(3), Aug(70–85). Retrieved from https://jqst.org/index.php/j/article/view/91.
• Kyadasu, R., Dave, A., Arulkumaran, R., Goel, O., Kumar, D. L., & Jain, P. A. 2024. "Exploring Infrastructure as Code Using Terraform in Multi-Cloud Deployments." Journal of Quantum Science and Technology (JQST), 1(4), Nov(1–24). Retrieved from https://jqst.org/index.php/j/article/view/94.
• Kyadasu, Rajkumar, Shyamakrishna Siddharth Chamarthy, Vanitha Sivasankaran Balasubramaniam, MSR Prasad, Sandeep Kumar, and Sangeet. 2024. "Optimizing Predictive Analytics with PySpark and Machine Learning Models on Databricks." International Journal of Research in Modern Engineering and Emerging Technology 12(5): 83. Retrieved from https://www.ijrmeet.org.
• Mane, Hrishikesh Rajesh, Shyamakrishna Siddharth Chamarthy, Vanitha Sivasankaran Balasubramaniam, T. Aswini Devi, Sandeep Kumar, and Sangeet. 2024. "Low-Code Platform Development: Reducing Man-Hours in Startup Environments." International Journal of Research in Modern Engineering and Emerging Technology 12(5): 107. Retrieved from www.ijrmeet.org.
• Mane, H. R., Kumar, A., Dandu, M. M. K., Goel, P. (Dr) P., Jain, P. A., & Shrivastav, E. A. 2024. "Micro Frontend Architecture With Webpack Module Federation: Enhancing Modularity Focusing On Results And Their Implications." Journal of Quantum Science and Technology (JQST), 1(4), Nov(25–57). Retrieved from https://jqst.org/index.php/j/article/view/95.
• Bisetty, S. S. S. S., Chamarthy, S. S., Balasubramaniam, V. S., Prasad, P. (Dr) M., Kumar, P. (Dr) S., & Vashishtha, P. (Dr) S. 2024. "Analyzing Vendor Evaluation Techniques for On-Time Delivery Optimization." Journal of Quantum Science and Technology (JQST), 1(4), Nov(58–87). Retrieved from https://jqst.org/index.php/j/article/view/96.
• Bisetty, Sanyasi Sarat Satya Sukumar, Aravind Ayyagari, Archit Joshi, Om Goel, Lalit Kumar, and Arpit Jain. 2024. "Automating Invoice Verification through ERP Solutions." International Journal of Research in Modern Engineering and Emerging Technology 12(5): 131. Retrieved from https://www.ijrmeet.org.
• Tirupathi, R., Ramachandran, R., Khan, I., Goel, O., Jain, P. A., & Kumar, D. L. (2024). Leveraging Machine Learning for Predictive Maintenance in SAP Plant Maintenance (PM). Journal of Quantum Science and Technology (JQST), 1(2), 18–55. Retrieved from https://jqst.org/index.php/j/article/view/7
• Abhishek Das, Sivaprasad Nadukuru, Saurabh Ashwini kumar Dave, Om Goel, Prof.(Dr.) Arpit Jain, & Dr. Lalit Kumar. (2024). N Optimizing Multi-Tenant DAG Execution Systems for High-Throughput Inference. Darpan International Research Analysis, 12(3), 1007–1036. https://doi.org/10.36676/dira.v12.i3.139
• Das, A., Gannamneni, N. K., Jena, R., Agarwal, R., Vashishtha, P. (Dr) S., & Jain, S. (2024). Implementing Low-Latency Machine Learning Pipelines Using Directed Acyclic Graphs. Journal of Quantum Science and Technology (JQST), 1(2), 56–95. Retrieved from https://jqst.org/index.php/j/article/view/8
• Prasad, Rohan Viswanatha, Aravind Ayyagari, Ravi Kiran Pagidi, S. P. Singh, Sandeep Kumar, and Shalu Jain. 2024. "AI-Powered Data Lake Implementations: Improving Analytics Efficiency." International Journal of Research in Modern Engineering and Emerging Technology (IJRMEET) 12(5):1.
• Prasad, R. V., Ganipaneni, S., Nadukuru3, S., Goel, O., Singh, N., & Jain, P. A. 2024. "Event-Driven Systems: Reducing Latency in Distributed Architectures." Journal of Quantum Science and Technology (JQST), 1(3), Aug(1–19).
• Akisetty, Antony Satya Vivek Vardhan, Rakesh Jena, Rajas Paresh Kshirsagar, Om Goel, Arpit Jain, and Punit Goel. 2024. "Leveraging NLP for Automated Customer Support with Conversational AI Agents." International Journal of Research in Modern Engineering and Emerging Technology 12(5).
• Akisetty, A. S. V. V., Ayyagari, A., Pagidi, R. K., Singh, D. S. P., Kumar, P. (Dr.) S., & Jain, S. 2024. "Optimizing Marketing Strategies with MMM (Marketing Mix Modeling) Techniques." Journal of Quantum Science and Technology (JQST), 1(3), Aug(20–36).
• Kar, Arnab, Ashvini Byri, Sivaprasad Nadukuru, Om Goel, Niharika Singh, and Arpit Jain. Climate-Aware Investing: Integrating ML with Financial and Environmental Data. International Journal of Research in Modern Engineering and Emerging Technology 12(5).
• Kar, A., Chamarthy, S. S., Tirupati, K. K., Kumar, P. (Dr) S., Prasad, P. (Dr) M., & Vashishtha, P. (Dr) S. Social Media Misinformation Detection NLP Approaches for Risk. Journal of Quantum Science and Technology (JQST), 1(4), Nov(88–124).
• Sayata, Shachi Ghanshyam, Rahul Arulkumaran, Ravi Kiran Pagidi, Dr. S. P. Singh, Prof. (Dr.) Sandeep Kumar, and Shalu Jain. Developing and Managing Risk Margins for CDS Index Options. International Journal of Research in Modern Engineering and Emerging Technology 12(5):189.
• Sayata, S. G., Byri, A., Nadukuru, S., Goel, O., Singh, N., & Jain, P. A. Impact of Change Management Systems in Enterprise IT Operations. Journal of Quantum Science and Technology (JQST), 1(4), Nov(125–149).
• Garudasu, S., Arulkumaran, R., Pagidi, R. K., Singh, D. S. P., Kumar, P. (Dr) S., & Jain, S. Integrating Power Apps and Azure SQL for Real-Time Data Management and Reporting. Journal of Quantum Science and Technology (JQST), 1(3), Aug(86–116).