CQ Clinical Trial Management System (CTMS)
A real-time view across clinical trial processes for higher-quality trial execution
Enable effective management of clinical trials with centralized data, transparent processes, and compliance with regulations
CQ CTMS powered by Cloudbyz integrates data and automates clinical workflows with visual dashboards and centralized issues management, so that you have the visibility and power to manage all your clinical trial activities in a single platform.
Effective management of clinical trials is at the heart of a successful research project completion and crucial to accelerate clinical studies. CQ CTMS powered by Cloudbyz is an intuitive site-based or decentralized clinical trials management solution that brings control and efficiency for both data flow and workflow, and quality data to every study, yielding cost savings in time, labor and operational expenses. It helps manage sites, enrollment, documents, events, milestones, site visit reports, finances, inventory and more. With CQ CTMS, research professionals have faster access to real-time data, allowing them to track and manage their studies from start to finish in compliance with Good Clinical Practices (GCP), 21 CFR Part 50 and 21 CFR Part 11.
“Make a Digital Transformation Journey Possible to Every Clinical Research Site”
Your One Place for Project and Site Management CQ CTMS enables comprehensive site and end-to-end project management of both your off-site and hybrid-based clinical project from the planning stage and throughout the conduct of the study. All your clinical project data from the planning stage and throughout the conduct of the study, is made available to you for making better real-world decisions. Your trial team can more efficiently track and manage organizational resources, tasks, milestones, budgets and activities at the Study or Site level. Site management is also equipped to set up, track and manage websites, evaluations and assessments, along with real-time site performance data and analytics.
Improve Investigator Collaboration
Getting a clinical trial started is one challenge. Getting the right qualified investigator for the trial is another. By leveraging an investigator database, CQ CTMS can easily send email campaigns targeted to different investigators and provide them access to feasibility studies of any existing/potential clinical trial. Once on-board, an Investigator Portal provides interactive data collection, robust collaboration tools and real-time data analytics with clinical sites, CRO and sponsors. It also improves data quality by having one place to access study details, payments, subject enrollment and exchange of eTMF documents. CQ CTMS offers a full suite of tools powered by data-driven insights and next generation technology to help physicians and investigators optimize the study process and to increase efficiency.
Hit Your Patient Enrollment Goals Faster
Today’s complex protocols and competing trials lead to exponentially greater challenges to recruiting and retaining qualified participants. Patient recruitment is one of the biggest risks to completing studies and hitting timelines. Sponsors need innovative approaches that seamlessly integrate unparalleled data, proven clinical capabilities, and advanced technologies across patient identification, recruitment, retention, and re-engagement. CQ CTMS offers complete end-to-end patient recruitment and retention across all the phases of clinical trials. The solution significantly empowers sponsors, CROs, and sites for the patient recruitment process with minimal handholding, better metrics, and improved analytical capabilities. It helps save your clinical research site time and money in tracking patient recruitment across selected sites, multimedia campaigns, pre-screening, subject enrollment, subject visit scheduling, and payment policies depending on budgets and protocols. A Patient Portal enables digital patient recruitment and self-registration for a better user experience. CQ CTMS eliminates redundant tasks so you can get back to the work that matters most: helping patients.
Enhance Patient Safety and Study Quality through Real-time Risk-based Monitoring and Reporting
Clinical trial monitoring requires data collection and analysis throughout a project to ensure appropriateness of the research and project design, validity and integrity of the data, compliance to standard operating procedures, and the health and protection of human subjects. Regardless of the method used, monitoring must be performed on a regular basis. CQ CTMS enhances patient safety and study quality by using data, analytics, and technology to monitor patient, site and study performance with risk-based and centralized monitoring to improve site efficiency and productivity. CQ CTMS provides the ability to plan, track and manage all aspects of on-site visits such as pre-study, site initiation, interim monitoring, and closeout. CRAs can view key information such as enrollment metrics and deviations at-a-glance, quickly author new monitoring visit reports based on configurable templates and track onsite monitoring activities. Site efficiency and productivity are improved with centralized information driving more accurate reporting and metrics. In addition, CQ CTMS facilitates secure remote monitoring and remote source data verifications, critical source document reviews, query management, action item tracking, follow-up letter generation and tracking, and automatic report roll-up to eTMF. A full complement of reports and dashboards provide total visibility into the status of each study, country, site and investigator to provide the information necessary to make the best decisions possible and ultimately to help promote good clinical practice.
Support Your Entire Clinical Organization
Every stakeholder of the clinical trial benefits from a real-time, centralized data view across the clinical trial lifecycle on multiple devices, anywhere, anytime. Our solution facilitates a significant reduction in the decision timings and accelerates on-time processing
Next generation Clinical solution easily supports your outsourcing model, study pipeline and global team to speed trial execution, improve decision making, and streamline clinical operations.
Real-time information on study participants and processes to ensure study safety, effectiveness and welfare of subjects while adhering to applicable regulations.
360-degree real-time visibility of all studies through dashboards and reports to ensure proper clinical trial execution, eTMF management, while maintaining compliance.
Digitally transform control of clinical trials from reactive to proactive through intelligence and data-driven decision-making enabling increased clinical trial success.
Easily enroll and have access to all latest study information anywhere, any device.
Better partnerships with suppliers, contractors, and sites to improve accountability, quality and safety of investigative product inventory
Improve site performance and eliminate redundant work through automated workflows and easy collection and access to real-time visit data.
Get visibility across issues in real-time to quickly identify systemic issues, reduce cost, and prevent recurrences.
Easier to monitor all safety aspects of a clinical trial through access to centralized safety data and documents to minimize delays in safety reporting.
Ensure easy access to documents and reliable clinical data anywhere, anytime.
Ensure consistency and quality of clinical research study objectives and protocols through streamlined automated processes across the entire clinical lifecycle.
Ability to drive streamlined and efficient clinical quality improvement processes ensuring compliance with cGCP and all applicable regulations.
Key CQ Clinical Solution Features
Clinical Trial Operations
Gain real-time view of operational performance to keep a smooth-running clinical trial process from start-up to closure.
Accelerate the study start-up process without sacrificing quality.
Deliver your trial on time and on budget with real-time oversight across clinical trial processes enabling faster, higher-quality trial execution.
Manage TMF content seamlessly and accurately while maintaining inspection readiness and compliance.
Fast and intuitive interface for capturing and reviewing data from anywhere, on any device.
Safety & Pharamacovigilance
Ensure participant safety, data integrity, regulatory compliance and on-time safety reporting.
Make it easy for your team to spot risk trends and resolve them proactively.
Maintain a state of inspection readiness by driving efficiency and effectiveness into the clinical audit management process.
Drive continuous improvement of your studies with a comprehensive yet easy to use solution designed to effectively manage your corrective and preventive (CAPA) processes.
Streamline your clinical supply chain by integrating quality, safety, performance management and collaboration tools to increase supplier performance while reducing risk and cost
Manage your critical trial files, SOPs, and documents at scale to drive productivity and efficiency while ensuring compliance.
Ensure your clinical team is trained, skilled and certified to drive productivity and maintain compliance.
Review, track and manage studies anywhere, at any time, on your own device.
Reporting & Analytics
Use real-time graphics for trial snap shots and trends to identify patterns as part of predictive analysis. Monitor trial open tasks and track outcomes via dashboards. Use built-in best practices reports or create your own.
Social Like & Follow
Like and follow relevant records in the system. Choose to be notified via email, dashboard, and mobile to stay abreast of developments