Benefits of a Clinical Trial Management System
Recent Articles AI-Powered Clinical Data Validation: Ensuring Accuracy, Efficiency, and Compliance September 21, 2024 Read More AI in Clinical Trials: Key to Accelerated Timelines & Reduced Costs July 29, 2024 Read More Simplifying eCRFs: A Look at the Future of Clinical Data Management July 8, 2024 Read More Benefits of a Clinical Trial Management System Clinion Team / January 20, 2020 Clinion CTMS – Discover, Transform and Enhance your Clinical Trials Clinical Trials are a humongous undertaking. They involve massive amounts of data, hundreds of people and many sites for investigation. Managing these trials in the highly regulated clinical research field is challenging. It involves the integration of various processes, risk management and adherence to stringent schedules. Clinion Clinical Trial Management System (CTMS) has been designed to simplify this complex operation and bring all the various elements of a study working together harmoniously under one system. Clinion CTMS Solutions – Simplifying Clinical Trials management Clinion’s wide expertise in scientific and medical domains bring with them capabilities to simplify clinical studies, reduce pain points and improve overall efficiency. Our solutions are effective, affordable and customizable to industry demand. Benefits of Clinion CTMS include: ➤ Clinion CTMS allows real-time management of multiple clinical trials ➤ CROs / Sponsors can efficiently manage their studies and obtain real-time information about: ➤ Study status – recruitment across sites – targets vs actuals ➤ SAE / AE reporting ➤ Budgeting, Expenses and invoicing ➤ Real-time Scheduling and monitoring of sites ➤ Efficient IP inventory management ➤ Clinical trial progress ➤ Improved operational efficiency ➤ Reduced costs CTMS Features- Adaptability and Robustness are our Strengths We offer a robust CTMS solution that can adapt to your project size and scale. Be it a single clinical study or a complete portfolio, Clinion CTMS is all you need to get the most of your clinical study processes and accelerate results. The features that are a part of Clinion CTMS are: Dashboards and Reports Comprehensive dashboards and reports show all action items on a single page. You can view inventory reports, finance and costing reports, budget reports, pending payments and invoices in this feature. Budgeting and Accounting Through this feature, our clients can frame the budget for each project, track invoices, and expenses, manage payments, and allow integration with third-party accounting software. Site Monitoring You can view the activity calendar, monitor various reports such as recruitment, safety features, CRF review and deviations from the protocol. Subject Recruitment This feature shows a comparative study of actual and target numbers. Reporting is done on metrics such as screened, randomized, excluded, dropped and integrations with EDC. Project Planning This is a critical reporting feature of our CTMS. You can use this to set up and view project milestones, assign CRA to sites, create schedules, plans and monitor them. IP Inventory Management This feature provides stock status updates, drug expiry reports, inventory receipts, and batch management. Document Management System (DMS) This CTMS feature allows the user to upload and share documents, folders, and grant permission to access them. Safety Reporting This allows for SAE reporting and tracking, SAE data import and integration with EDC system. Regulatory Compliance Activity logs are maintained with checks for compliance with 21 CFR Part 11 and SOP’s are documented. Why is CTMS right for your clinical studies? We can make your clinical trial management effective through the following ways: · Our project management tools allow for real-time clinical study management · Through our system, project managers can study and update reports in real-time. · Our inventory management system tracks the inventory right from the issue until delivery. It maintains stock info and issues alerts for refills in real-time. · Our powerful financial management feature helps keep track of milestones, expenses, payments, and budgeting · Due to continuous monitoring of finances and inventory, a high degree of operational efficiency is achieved. Optimized project management techniques are the primary feature of our CTMS System which will contribute immensely towards cost reduction for your business.
Implementing a Clinical Data Management System (CDMS)
Recent Articles AI-Powered Clinical Data Validation: Ensuring Accuracy, Efficiency, and Compliance September 21, 2024 Read More AI in Clinical Trials: Key to Accelerated Timelines & Reduced Costs July 29, 2024 Read More Simplifying eCRFs: A Look at the Future of Clinical Data Management July 8, 2024 Read More Implementing a Clinical Data Management System (CDMS) Clinion Team / November 27, 2019 Clinion – Clinical Data Management System We at Clinion understand how clinical data can completely impact the cost, effectiveness and turnaround time of any clinical study. Clinion’s Clinical Data Management System (CDMS) works towards storing and managing EDC and Paper-based data of clinical studies. The clinical data gathered as a result of the investigative process is stored in CDMS. Clinion’s CDMS is responsible for collecting, cleansing and maintaining accurate, high-quality data compliant with all regulations. The key function of our CDMS is to reduce the errors in data handling and make it qualified for analysis in minimum cycle time. Clinion-Complete Solutions for Data Management For any clinical trial, Clinical data management system data is critical as it can make or break the CDMS project in terms of results, costs, and time. As the demand for pharmaceutical products increases, accurate data that meets the quality assurance standards is imperative in the drug evaluation process. The steps in Clinion CDMS to produce feasible, scalable and error-free clinical data are: Data Design Data design involves creating multiple studies through logical steps using various design tools such as eCRF (Electronic Case Report Form) Designer and Global Library. The complete CRF is generated dynamically by the system based on the study configuration. The driving standard for this is the clinical trial protocol and the Case Report Form (CRF). Data Entry and Capture Data entry occurs as per the clinical data management process. The eCRF controls data entry, validation, changes, updates, deletions, and edition. All these are monitored and tracked by the CDMS. Data entry access is controlled and verifiable. Data entry is also immutable – all changes are tracked and can be retrieved at any point in time, making the system compliant with FDA guidelines. Data Management Form design and validation checks are key to data consistency and reducing data discrepancies. Various tools like edit checks, source document verification, query workflow, dashboards, AE/SAE reports are available to data managers to ensure high-quality data capture and storage. Accurate validation checks are mandatory in Clinion CDMS. How our solutions help accelerate clinical trials Our CDMS system improves the productivity of clinical studies significantly by: Setting up a Clinical Study in days instead of weeks or months We have simple, robust, user-friendly application interfaces that allow users to quickly configure forms and edit checks and publish the site to production for data capture. No compromise on Data Accuracy While our system provides user-friendly data forms for rapid data entry, we leave no scope for inaccuracy. There are manual and auto edit checks throughout to ensure the correctness of data. The key features of Clinion CDMS are: Enables quick clinical study setup Captures robust and accurate data Maintains data accuracy through edit checks, source data verification, querying reports and alerts and notifications. Helps monitor real-time data Ability to integrate with CTMS, IWRS, CDISC, and other applications Simple to set up and implement Effortless data sharing made possible through our Cloud-based system We, at Clinion have over a decade of expertise in providing clinical trial solutions to pharmaceutical, biotech, and medical device companies. Our innovative technologies and advanced clinical data management solutions have streamlined and optimized clinical studies significantly. Want to know more about what Clinion eClinical Platform has to offer? Request a Demo
