CQ Electronic Trial Master File (eTMF)
Manage essential trial documents, stay inspection ready and collaborate in real-time with study partners
Know what is required, what is completed, and what is missing in your eTMF at all times
Managing essential documentation for clinical trials has become quite complex in today’s clinical research environment. Study sponsors are required to implement a quality system to ensure regulatory compliance of data and documentation and ensure availability of study documentation throughout the trial and for years after the study is completed. With this increased complexity of clinical trials today, larger volumes of documentation are being captured across multiple departments accelerating the need to shift from the traditional paper-based approach to a smarter, digitalized and organized manner of managing trial master files.
CQ eTMF solution, based on the DIA TMF Reference Model, increases real-time visibility into all TMF artifact activities and integrates with other quality and compliance-critical functions. Know what is required, what is completed, and what is missing in your eTMF at all times. The solution alleviates administrative burden and simplifies assigning, creating, collaborating, reviewing, and approving all TMF artifacts with more efficiency.
“38% of clinical trial sponsors currently describe their ability to access data and records from the TMF archive as ‘extremely inadequate’. This rises to 65% amongst QA, compliance, legal and regulatory professionals.” -Arkivum report: TMF Futures, Keeping Data Alive, 23 September 2020
CQ eTMF provides the ability to include all contributors, such as sponsors, CROs, vendors and study sites in a secure and organized manner. It ensures quality, completeness, compliance and a constant state of inspection readiness of an electronic clinical trial master file and proof of a study’s compliance with current good clinical practice (GCP). Additional features include pre-built templates, ZIP file downloads to facilitate file submissions, folder structure access on clinical study record level, and restricted/user permission configured file access.
Flexible Pre-Defined TMF Reference Model
CQ’s eTMF solution enables clinical trial organizations and stakeholders to automate the labor intensive clinical trial content management processes of your eTMFs. It’s pre-configured to the current DIA TMF Reference Model and modifiable to meet your business needs. Users can easily create the relevant artifacts with published templates to speed time to creation and minimize errors.
Drag & Drop Upload
The drag & drop functionality in CQ eTMF ensures flexibility with easy movement of one or more files for uploading in the desired electronic trial master file folder. Easy to use bulk importing / exporting of artifacts and related documents provide for easy transfer of study documentation at study start-up and study closeout.
Document Approval and Generation
CQ eTMF’s document approval feature transforms manual paper handling tasks with automated collection, classification, indexing, email archives, and medical imaging for ideal results. In addition, it facilitates easy document generation in the CTMS such as site green light process, protocol deviation, adverse events and trip reports and saves them to your eTMF with the click of a button.
Collaboration across your Stakeholders
Managing collaborative processes within the eTMF combines information exchange and tracking into a single system. CQ eTMF provides a secure environment to view and access content with internal contributors and across trial partners, sites, and team members for better collaboration and faster trials. All parties have direct access thus making physical distribution of content obsolete and in turn eliminating the need to email copies of documents as attachments. With controlled security, long-term retention of archived clinical trial documents is possible and they remain accessible online for instant viewing and sharing by your clinical study team. Not only does collecting TMF documents become more efficient, but all parties gain visibility into the status and outstanding tasks.
Real-time Connectivity and Communications throughout the Study
Clinical trial stakeholders can securely access your trial master file on the
go–anywhere, anytime and on any device. Complete access to the solution including artifacts, reports, approvals, record views, reviews, alerts etc. ensures business continuity and improves clinical efficiency, visibility and flexibility. The solution also enables notifications about an artifact change of state and any task item needing attention. Chatter function helps study teams discuss changes to artifacts in real time thus cutting down on meetings and email traffic while keeping all comments with the related artifacts for easy reference.
“The knowledge worker spends about 2.5 hours per day, or roughly 30% of the workday, searching for information.”
Robust Searching and Reporting Capabilities
CQ eTMF solution supports full text search of documents, metadata and attachments to find and review critical trial information faster. Study teams can spend less time searching and more time managing the eTMF process. In addition, you can easily report on any data collected in the system. Stakeholders can view and assess critical metrics through reports and dashboards about timeliness, quality, missing approvals, expiring documents and completeness of your eTMF. Study team and management have immediate insight about the health of all your clinical documents.
Inspection Readiness and Compliance
Fully compliant with 21 CFR Part 11, Annex 11, GDPR, and HIPAA regulations including compliant eSignatures and fully automated audit trails, CQ eTMF solution keeps you inspection ready.
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