CQ Electronic Data Capture (EDC)
The right clinical data, at the right time, on any device providing the power of insights beyond just numbers
Streamline data collection and management in real time to ensure transparency, data integrity and quality of your data integrated with your CTMS
CQ EDC powered by Cloudbyz streamlines the clinical trial data collection process so that you have visibility and capability to manage all your clinical data in a single platform already connected to your CTMS.
The success of a clinical trial depends on data received at the end of the trial. Data collection faces many challenges including trials that span across several locations and countries comprising of hundreds of different pieces of data to be compiled and processed for statistical analysis. By providing a single portal and database, clinical trial investigators and managers have a single source of highly organized and standardized information with the privacy, performance, and ability to meet regulatory requirements, facilitate trouble-free data entry, and to gain data insights in real-time.
Electronic Case Report Form (eCRF)
By providing a single portal and database to input, visualize and analyze data, clinical trial investigators and managers have a single source to turn to for highly organized, standardized and quality information that can be quickly analyzed, sorted, drilled down for quality check reviews, and exported for clinical trial’s progress.
- Leverage eCRF templates for quick setup and to ensure accurate structuring and easy submission and navigation.
- Data entry screens match paper CRFs for easy user adoption.
- Allows study team to provide their own devices to patients or allow patients to use their own devices.
- Provides more timely, complete, and accurate case data in real time action.
- Helps in early detection of patient/therapy issues that can be responded to quickly.
- Able to identify trends and risk factors for proactive decision-making.
- Eliminates the errors that could occur in manual data entry, reporting and maintenance.
eCOA / ePRO
Enhance patient experience, view data in real-time, and manage responses all in one place while assuring your data is more accurate, complete, and secure.
Today, more than 25% of clinical trials use patient-reported outcomes, digital or otherwise. With the healthcare industry’s focus on the “patient,” PROs (or Diaries) are an important tool for understanding the real impact of a new potential treatment on patients. While some measures can be effectively captured during site visits, others are better tracked as close to real-time as possible, such as pain symptoms. This is where capturing electronic patient-reported outcomes (ePRO) allows for immediate and regular collection of symptom data resulting in better data quality, increased compliance, and reduced patient burden.
- You can collect data from anywhere – at home, work, or in-clinic on whichever device meets your patients’ needs.
- Improve adherence with flexible scheduling based on patients’ time zones, closeout windows that support time-sensitive data collection, and notifications that integrate with each patient’s lifestyle – all while ensuring compliance with your protocol and boosting patient engagement.
- Reduce the time burden of completing the questionnaire eliminating missing and data duplication, transcription errors, incorrect interpretation of hand-written responses, and the need for source data verification.
- Patients have a better overall experience and are more compliant when using electronic devices to record outcomes rather than paper diaries.
- Patients feel safer knowing clinicians have real-time access to the information they report
In addition, the same can be applied to electronic clinical outcome assessments (eCOA) that can easily capture input provided by clinicians for electronically recorded outcomes.
The availability of ePRO and EDC together enables a centralized view of all clinical and patient-reported data resulting in an accelerated study build time. It ensures flexible workflows to support both remote and on-site clinical trials.
eConsent
Improve your consent process, gain insight, optimize the patient experience, and ensure patient comprehension.
With 85% of studies failing to retain enough patients, 30% of patients dropping out of studies, and 8% of those patients dropping out due to failure to understand study requirements, the consent process can make or break study success.
eConsent offers a better way to reach your patients, explain your expectations, and even enhance your compliance—no paper needed. eConsent enables you to create patient-friendly template-driven informed consent forms for mobile devices enhanced with advanced digital features like video and audio and translation to native languages, without sacrificing global compliance.
eConsent does more than digitize patient enrollment. It raises patient comprehension and retention, eases workloads for study teams and sites, and improves data quality to support clear and confident decision-making. It improves adherence in clinical trials by ensuring study participants sign the correct consent form version with date and time stamps. And it provides traceable consenting to eliminate data ambiguities and inspection findings.
eConsent helps you maintain complete control over your consent process with a clear understanding of subject status, including reasons for refusal. It improves your data quality, reduces errors, be certain your consent process is compliant and provides real-time triggers, notifications, progress metrics, and reporting. By switching from traditional forms to eConsent forms, sponsors can expect significant improvements, such as enhanced clinical data quality and traceability, minimized audit findings, real-time visibility and monitoring, increased site efficiencies, as well as a centralized data.
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
Sponsors
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.
Investigators
Real-time information on study participants and processes to ensure study safety, effectiveness and welfare of subjects while adhering to applicable regulations.
Clinical Operations
360-degree real-time visibility of all studies through dashboards and reports to ensure proper clinical trial execution, eTMF management, while maintaining compliance.
CROs
Digitally transform control of clinical trials from reactive to proactive through intelligence and data-driven decision-making enabling increased clinical trial success.
Patients
Easily enroll and have access to all latest study information anywhere, any device.
Clinical Supply
Better partnerships with suppliers, contractors, and sites to improve accountability, quality and safety of investigative product inventory
Sites
Improve site performance and eliminate redundant work through automated workflows and easy collection and access to real-time visit data.
Management
Get visibility across issues in real-time to quickly identify systemic issues, reduce cost, and prevent recurrences.
Regulatory/Safety
Easier to monitor all safety aspects of a clinical trial through access to centralized safety data and documents to minimize delays in safety reporting.
Monitors
Ensure easy access to documents and reliable clinical data anywhere, anytime.
Clinical Development
Ensure consistency and quality of clinical research study objectives and protocols through streamlined automated processes across the entire clinical lifecycle.
Quality
Ability to drive streamlined and efficient clinical quality improvement processes ensuring compliance with cGCP and all applicable regulations.
Key CQ Clinical Solution Features
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.
Study Start-Up
Accelerate the study start-up process without sacrificing quality.
CTMS
Deliver your trial on time and on budget with real-time oversight across clinical trial processes enabling faster, higher-quality trial execution.
eTMF
Manage TMF content seamlessly and accurately while maintaining inspection readiness and compliance.
EDC
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.
Risk
Make it easy for your team to spot risk trends and resolve them proactively.
Audit
Maintain a state of inspection readiness by driving efficiency and effectiveness into the clinical audit management process.
CAPA
Drive continuous improvement of your studies with a comprehensive yet easy to use solution designed to effectively manage your corrective and preventive (CAPA) processes.
Supplier Management
Streamline your clinical supply chain by integrating quality, safety, performance management and collaboration tools to increase supplier performance while reducing risk and cost
Document Management
Manage your critical trial files, SOPs, and documents at scale to drive productivity and efficiency while ensuring compliance.
Training
Ensure your clinical team is trained, skilled and certified to drive productivity and maintain compliance.
Mobile Access
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
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