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Product Lifecycle Management
Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Design Quality
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Complaints Management
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Document and Learning Management
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Quality Management
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Risk Management
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Supplier Management
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Safety Management
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
Environment and Sustainability
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
Leveraging CAPA for Continuous Improvement
Ensure your laboratory is compliant with systematic and efficient laboratory investigations
Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
Conduct smart management review meetings with a tower of data to improve your quality and safety systems
Gain 360 degree vision into enterprise wide Safety risks
Enhance Safety and Compliance with Smarter Chemical Management
Ensuring Quality across Departments & Locations
Partner With Suppliers And Vendors To Improve Quality And Safety
Create Loyalty by Addressing Customer Complaints Smartly
Bring Consistency to Permit Practices
Make it easy for your people to manage, track and analyze environmental and sustainability metrics
Bring higher quality products to market quicker with design controls, projects & DHF
Streamline Permit Management and Ensure Compliance
When Learning Propels Organizational Growth
Improve efficiency, productivity, and compliance with a solution designed for today's diverse workforce learning styles
Strategically manage the complete lifecycle of your product
Efficient Waste Management for Compliance & Sustainability
Relevant Information within reach - Always.
Assuring Quality Products and Services
Self-guided Product Tours
Product Demo Videos
Pricing
ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
Salesforce
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
CQ Platform
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
Recent Blogs
Recent Infographics
Recent Case Studies
Featured Case Study
ComplianceQuest Medical Devices QMS Success Stories eBook
Recent Checklists
Featured Checklist
Complaint Handling Process for MedTech and Life Science Companies
Course Offerings
Recent CQ Guides
Featured CQ Guide
Datasheets
Brochures
Demo Center
Podcasts
Podcast
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Videos
Recent Webinars
Webinar
Unlocking the Value of Complaints
Recent Whitepapers
Whitepaper
Why You Need to Digitally Transform Your QMS
Recent Compliance
Compliance
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Infographic
Safety Technology Trends to Watch in 2023 (Infographic)
Recent Toolkits
Featured Toolkit
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
Events and Webinars
Events
Upcoming Webinars
Featured Event
Interphex
01 Apr, 2025
New York, NY
About
About ComplianceQuest
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase product, quality, safety, and supplier as they bring their products from concept to customer success.
Meet the Leadership Team
Careers
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Corporate Citizenship
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
Customers & Testimonials
Newsroom
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Partners
Stronger Together: How our partnerships drive success and innovation
Upcoming Events
A Clinical Quality Management System is a comprehensive framework focusing on patient safety, regulatory compliance, and continuous improvement
With CQMS, healthcare practitioners can improve overall clinical performance and patient satisfaction
Effective clinical trial management is critical to research success and accelerating clinical studies. This requires data collection and analysis throughout the entire project period while meeting the needs of research and project design, validity and integrity of the data, compliance with SOPs, and the health and protection of the participants. There are various challenges while conducting clinical trials, including patient recruitment, getting the right qualified investigator for the trials, and managing all the data throughout the trial period. Due to the various parameters involved, regulatory bodies started to enforce a robust Clinical Quality Management System that will help organizations handle trials systematically and diligently.
Circuit Clinical is Raising the Bar on Quality as it Scales and Matures
The quality assurance transformation of one clinical research startup can be largely attributed to the visionary leadership of Mariah Fisher.…
Often clinical trial management and quality management are viewed as separate activities with different teams taking responsibility for each. However,…
A clinical trial takes years to conclude. Organizations such as biotechnology, pharmaceutical, medical devices company, and healthcare institution that conduct these trials need a proper system through a streamlined process. A Clinical Quality Management System (CQMS) is used exclusively to handle clinical research. Using a Clinical Quality Management System (CQMS) helps reduce data processing time and improve clinical study administration throughout the entire trial lifecycle. These systems help meet regulatory standards, enhance protocol and document management, and accelerate the trial’s ability to meet the goal.
ComplianceQuest offers a robust Clinical Quality Management System (CQMS) that supports end-to-end clinical trial operations with real-time data visibility. This solution becomes a ‘one-stop-shop’ for all clinical operations and quality needs. Team members across various departments can collaborate on a single task for the same study and access the updated data in real time. The single platform helps consolidate and update data that all stakeholders can use to make data-backed real-time decisions.
A Clinical Quality Management System solution is aimed at reducing decision timings and accelerating on-time processing. To that end, there are five key elements that should be considered important in a CQMS. They are:
Reduce dependency on manual methods of pulling trial-critical information to improve patient and participant safety.
Track and manage clinical trial studies from start to finish in compliance with Good Clinical Practices (GCP), FDA 21 CFR Part 50, and 21 CFR Part 11.
Leverage data, analytics, and technology to monitor patient, site, and study performance with a risk-based approach and create a centralized monitoring system to improve site efficiency and productivity, and quality assurance.
A single platform that includes reports and dashboards provides total visibility into the status of each study, country, site, and investigator to create a holistic approach to patient study and trial.
A Patient Portal enables digital patient recruitment and self-registration to eliminate redundant tasks and instill proactiveness among participants.
A research study, such as a clinical trial, is a large and complex process. Doctors and researchers spend years on a single clinical trial to understand the severity of a disease or even develop new drugs to cure them. However, the length of the study comes with its own set of challenges, including limited resources, capital, and operational investment for different phases of the trial, and participant selection, among others. Research facilities and life-sciences organizations need a streamlined process to properly execute clinical trials. Manual handling of paperwork or legacy methods such as spreadsheets comes with its own drawbacks. This is where a robust Clinical Quality Management System comes into play. Having a Clinical Quality Management System will help:
With the availability of consolidated and updated data on a single platform, stakeholders of the clinical trial can track all parties involved and benefit from data-backed real-time decision-making.
Modern CQMS offers visual dashboards and centralized issue management that all stakeholders can leverage to gain visibility and power to manage all trial activities in a single system. Integrating data and automating clinical workflows makes it easier to conduct decentralized or virtual trials.
Having a centralized data view enhances safety signal detection, thus easing site burden.
As there is comprehensive control, organizations can witness a significant reduction in the decision timings and accelerates on-time processing.
CQ Clinical QMS fosters best practices for study team members to work together:
Quickly resolve any patient or participant-related queries and accelerate go-to-market time.
Use the solution as a single source of truth to improve the overall health and effectiveness of clinical trials.
Minimize risks such as non-compliance or any other potential disruptions through change traceability across the organization.
Support every stakeholder of the clinical trial, including sponsors, CROs, sites, monitors, investigators, patients, management.
Seamlessly use the system to manage clinical development, operations, supply, regulations, and quality.
Stay compliant with regulations, including ISO 14155, ICH E6 (R2), and other EU regulations, while being audit ready.
We have rolled-out CQ across our company to automate various elements of QMS requirements such as Document Management, Complaints, Non-conformances, Corrective Action (8D and A3), Supplier Management and Audit Management. We have been using the software for more than 2 years. We are glad to see how well the system is being used across the company. We have several thousand users on the system currently and working to scale the usage further. CQ solution has been configured to meet our needs, works elegantly across languages, across time zones, and business verticals. With integration between CQ and SAP to exchange critical data, the process automation provides a lot of productivity.
Lia Budiman,Solution Consultant, Continental Contitech
Powered by Cloudbyz, CQ Clinical Quality Management System is a next-generation end-to-end clinical trial operations system that improves clinical data access. It is a cloud-based, centralized solution that offers real-time data visibility. CQ Clinical QMS is focused on offering streamlined, customer-centric support across all four phases of clinical trials, including study-start-up, patient recruitment, budgeting, pharmacovigilance, and much more. With CQ’s CQMS, companies can handle various challenges, including:
AI in clinical trials is gaining momentum for its ability to dramatically improve the probability of success and reduce timelines. This is because it uses predictive analysis from available historical data. The average timeline for a drug molecule to be released from lab to market is nine years, with a median development cost of $2 billion. The objective of AI implementation is to eliminate unnecessary repeated clinical evaluations, save costs & time, and thereby ensure successful clinical trials. AI-based Clinical Trial transformation process can be divided into three main components:
To know more, read our white paper on ‘End-to-End Management of Clinical Trials: Why Digital Transformation Holds the Key.’
MDSAP Quality Management System (QMS) Assessment Checklist (Part 4): Nonconformity, Corrective Actions and More
Checklist | April 6th, 2022
Pharmaceutical Quality Management System – Continual Improvement (Part – B)
Checklist | July 28th, 2021
Quality Management System for Clinical Trials: A Risk-based Approach
Checklist | October 12th, 2021
Pharmaceutical Quality Management System – An Effectiveness Review (Part – A)
ICH E6 (R2) Good Clinical Practice is an international ethical and scientific quality standard that was developed to provide public assurance that the safety, rights, and well-being of trial participants are protected and consistent with the principles throughout the trial.
ISO 14155:2020 is an international quality standard that acts as a guideline to manage clinical investigations of medical devices for human subjects.
(EU) No 536/2014 from European Medicines Agency Clinical Trials Regulation mandates clinical research companies to comply with the standard to assure the public and the regulatory agencies that the subjects are protected while the data generated is robust and reliable.
Gain a real-time view of clinical trial operations.
Accelerate the study start-up process without sacrificing quality.
Maintain inspection readiness and compliance while managing TMF content accurately.
Ensure participant safety, data integrity, regulatory compliance, and on-time safety reporting.
Maintain a state of inspection readiness by driving efficiency and effectiveness into the clinical audit management process.
Ensure all members of the clinical team are trained and certified.
In today’s interconnected and fast-evolving global supply chain landscape, ensuring supplier quality is no longer a back-office task—it’s a strategic…
Selecting the right Quality Management System is one of the…
In the high-stakes world of electronics manufacturing, ensuring product quality…
In today’s global and “connected” manufacturing landscape, contract manufacturers play…
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