CQ Study Start-Up
Clinical trials that get off to a good start are more likely to be successful trials. Study startup is a time-consuming component of the clinical study that can be significantly delayed due to manual and heavily paper-based processes, requiring multiple approvals and hand-offs between the sponsor and the sites. As trials and protocols increase in complexity, moving beyond spreadsheets to manage study start-up processes becomes critical to ensure on-time site activations and visibility into where bottlenecks lie. A proactive start-up plan is effective in ensuring balance, especially when coupled with the use of standardized tools, templates, and processes. CQ Study Start-Up powered by Cloudbyz provides the ability to track site performance metrics, site profiles, perform feasibility surveys and provide a centralized location for accessing and sharing all study-level information to help clinical teams make better informed decisions.
“Study failure is every sponsor’s biggest nightmare. Failure can be minimized or avoided by careful planning starting at the feasibility assessment stage where the study is reviewed from multiple angles by the different cross-functional stakeholders.”
Site Feasibility and Assessment
CQ Study Start-Up allows Sponsors to find the right site faster with built-in best practices that automate and streamline site identification, feasibility, and selection processes. It provides the ability to easily collect investigator and facility data to make better decisions about sites that should be qualified. Feasibility assessments can be quickly created from configurable templates and made accessible online to qualifying sites for easy completion and tracking. Key metrics, milestone dates and assessment responses are tracked in real-time by the system to assist Start-up specialists and managers with faster feasibility evaluation, site activation, and future planning.
Adopting an online feasibility tool can reduce the costs and effort devoted to e-mailing feasibility questionnaires, attending to follow-up reminders, and waiting to receive completed questionnaires. Manual tracking and analysis of feasibility responses are eliminated. Moreover, the availability of standard and customizable feasibility status update reports and dashboards will benefit study management teams seeking to keep up with all the activities tied to global trials.
Site Performance Metrics
Study teams need the best, real-time information to make the right decision at the right time and to keep the start-up on track. Having access to key performance indicators at multiple levels (site, study, etc.) in real time enables the study team to review individual site performance metrics such as non-enrollers, start-up metrics as well as trend data for the study and other trials. This makes it possible to closely track trends for a site or study (open queries, contract timelines, site selection/initiation visit cycle times, and enrollment factors). Data can then be compared to that from other studies, thus providing predictive intelligence and a powerful impact on future studies and startup planning. CQ Study Start-Up provides a Site Performance Metrics Portal to not only help identify weaknesses and mitigate potential roadblocks, but to also empower study teams make proactive, informed decisions. Additionally, it improves transparency and communication with all stakeholders.
With a workflow-driven process aided by secure digital capabilities, creating and updating documents is simplified. You can streamline the entire study and trial operational document review/approval process easily, on a consistent and timely basis. Increase operational efficiency by improving access to the right version of your study documentation, faster and more cost-effectively, regardless of location. With CQ Study Start-Up, you can manage the entire document lifecycle, gain complete visibility and rely on a single source of truth across all locations for more effective decision making, reducing both time and risk.
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