Just a moment, the page is loading...
Browse ALL STUDIES
Keyword Search
View All Selected
Clear All
Login / Create Account
Login
Create Account
Home
About Us
Privacy Policy
Minimum System Requirements
How To Join
Mission
Data Sponsors
Researchers
How It Works
How to Request Data
Review of Requests
Data Sharing Agreement
Access to Data
Independent Review Panel
Metrics
FAQs
News
Help/Contact Us
Development of an Automated Clinical Data Management and Analysis Platform for Streamlined Reporting and Regulatory Compliance
Proposal
12612
Title of Proposed Research
Development of an Automated Clinical Data Management and Analysis Platform for Streamlined Reporting and Regulatory Compliance
Lead Researcher
Anil Mogha
Affiliation
K3-Innovations, Inc
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
31 March 2025
Lay Summary
Overview: The purpose of this project is to develop a software application that can help organizations better manage and analyze clinical trial data. Clinical trials produce large amounts of data that must be processed, analyzed, and reported accurately to ensure that new treatments are safe and effective. However, handling this data manually can be time-consuming and prone to errors.Background: Currently, many organizations face challenges in efficiently managing clinical trial data and generating the necessary reports for regulatory approval. These challenges are due to the complexity of clinical data and the need to follow strict regulatory standards. Our project aims to address this by creating an automated platform that can streamline data management, perform statistical analyses, and generate reports that meet regulatory standards. By automating these tasks, we hope to reduce the time and effort required, and minimize the risk of errors.Objectives: The main goal of this research is to develop a user-friendly software application that can automatically process clinical data, perform necessary statistical analyses, and generate standardized reports. This software will help researchers and organizations save time, improve accuracy, and comply with regulatory requirements. The project will focus on refining the software's capabilities and demonstrating its effectiveness using real clinical study data.
Study Data Provided
[{ "PostingID": 4189, "Title": "NOVARTIS-CZOL446H2310", "Description": "Multinational, multicenter, double-blind, randomized, placebo-controlled, parallel group study assessing the efficacy of intravenous zoledronic acid in preventing subsequent osteoporotic fractures after a hip fracture" },{ "PostingID": 21045, "Title": "NOVARTIS-CACZ885M2301", "Description": "Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events) (CANTOS)" },{ "PostingID": 21068, "Title": "NOVARTIS-CAIN457F2310", "Description": "16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis (MEASURE2)" }]
Statistical Analysis Plan
Publication Citation
© 2025 ideaPoint. All Rights Reserved.
Powered by ideaPoint.
Help
Privacy Policy
Cookie Policy
Help and Resources