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Clinical Quality Management System

A clinical quality management system (CQMS) is a comprehensive framework to streamline processes, policies, and technologies to ensure the highest patient care and safety standards.

It has various data collection, analysis, and reporting tools. Healthcare providers can use these tools to identify and address issues such as adverse events, patient outcomes, and compliance with regulatory requirements.

clinical quality management system
clinical quality management system

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.

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What is a Clinical Quality Management System (CQMS)?

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.

clinical quality management system cqms

Key Elements of the Clinical Quality Management System

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.

Clinical and Quality Management

Need for Clinical AND Quality Management in Clinical Research

Why is a Clinical Quality Management System a Must?

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:

  • Manage the complete clinical trial lifecycle

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.

  • Collaborate with CROs, sponsors, and sites in real-time

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.

  • Reducing variation in data collection

Having a centralized data view enhances safety signal detection, thus easing site burden.

  • Faster trials increase speed time to market

As there is comprehensive control, organizations can witness a significant reduction in the decision timings and accelerates on-time processing.

why is a clinical quality management system a must

clinical quality management system datasheet


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clinical quality management system datasheet
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Benefits of CQ’s Advanced Clinical Quality Management System

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.

Great product, support, and people to work with!

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

continental contitech
continental contitech

Clinical challenges can be Effectively Handled with CQ's CQMS

effectively handled clinical challenges with CQ's clinical quality management system

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:

  • Financial challenges such as resource upskilling cost, mismatched and delayed payments hampering overall trial, and loss of revenue from delayed market introduction.
  • Branding challenges including regulatory or compliance penalties, stakeholder, partner, and study collaborator dissatisfaction, or brand erosion.
  • Clinical challenges like a delayed clinical trial start-up with fragmented information, no CAPA for flawed processes around clinical trials, patient drop-outs and retention issues, and no data-driven decision making.
  • Time-bound challenges such as downtime impact, increased time-to-market, delayed product approvals, and no real-time data visibility lead to delayed decision-making.
how AI helps in clinical trial and clinical quality management system

How can Artificial Intelligence (AI) Help Clinical Trials?

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:

  • Innovative study design
  • Smart data-driven analysis
  • Smart assistant with Salesforce Einstein platform, which can be integrated into a CTMS

To know more, read our white paper on ‘End-to-End Management of Clinical Trials: Why Digital Transformation Holds the Key.’

CQ’s Clinical Quality Management System supports end-to-end clinical trial operations with real-time data visibility by accelerating timely processing and reducing decision-making time.

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Quality-centric Companies Rely on CQ QMS

  • affinivax mono
  • verily mono
  • 3m logo mono
  • tupperware mono
  • continental logo mono
  • vyaire mono
  • lifescan mono
  • janssen mono
  • lundbeck mono
  • cdc logo mono
  • qlik mono
  • csa group mono
  • impossible mono
  • fluence mono

Frequently Asked Questions

  • 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.


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