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Audit Management Software System for Progressive Companies

Audit Defense Readiness

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CQ Clinical is your ‘one-stop-shop’ for all clinical operations and clinical quality needs

Accelerate clinical trial processes with the next generation cloud solution to reduce data processing time and improve clinical study administration across the entire trial lifecycle

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Why CQ Clinical Management Solutions

CQ Clinical, powered by Cloudbyz, delivers a next generation modern cloud, centralized solution of end-to-end clinical trial operations with real-time data visibility. CQ Clinical ensures streamlined, customer-centric support throughout the distinctive requirements across all four phases of clinical trials including study-start-up, patient recruitment, budgeting, pharmacovigilance, and much more. It also helps in cohesive communication amongst CROs, sponsors, sites, and all other stakeholders involved.

Challenge

A clinical trial is a large and complex process and Study teams are increasingly being challenged to do more with fewer resources. On average, the lifecycle of a clinical trial across all phases can be over 12 years with the capital and operational investment might be nothing less than million dollars per phase. Therefore, proper execution of clinical trials through a streamlined process is paramount for optimal outcomes.

 

Financial Impact

  • Higher study partner and resource maintenance cost
  • Increased cost per process/ phase/ downtime
  • Resource upskilling cost
  • Mismatched and delayed payments hampering overall trial
  • Loss of revenue from delayed market introduction

Brand Impact

  • Increased clinical trial risk
  • Multiple trial failures impacting brand credibility
  • Regulatory or compliance penalties
  • Stakeholder, partner, and study collaborator dissatisfaction
  • Brand erosion

Clinical Impact

  • Delayed clinical trial start-up with fragmented information
  • No corrective plans (CAPA) for flawed processes around clinical trials
  • Patient drop-outs and retention issues
  • No data-driven decision making

Time Impact

  • No real-time data visibility leading to delayed decision-making
  • Increased time-to-market and delayed product approvals
  • Downtime impacts
  • Time-lapse in several site management

Who We Help

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.

Who We Help
CQ Clinical Solution 6 Key Areas

CQ Clinical Solution 6 Key Areas

  • 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 & Pharmacovigilance: Ensure participant safety, data integrity, regulatory compliance and on-time safety reporting.

Manage the Complete Clinical Trial Lifecycle

CQ Clinical, powered by Cloudbyz, gives companies comprehensive control over how clinical trials are operated, streamlined, recorded, reported, and tracked in compliance with industry regulations and benchmarks. With the availability of consolidated and updated data on a single platform, stakeholders of the clinical trial can track all parties involved and benefit with data-backed real-time decision making.
“You need a next gen clinical trial management system that unifies and streamlines workflows while still maintaining full visibility.”

Complete Clinical Trial Lifecycle
CTMS

Collaborate across CROs, Sponsors, and Sites in Real-Time

With the significant disruption in clinical trials in 2020 and the new normal that has been established, life science companies are looking for novel ways to digitally transform their clinical trials to improve speed, agility, and patient engagement. Your entire team can benefit from transforming how you work with your CROs, sites and other stakeholder by integrating a collaborative system into your operations.
CQ Clinical fosters best practices for members of a study team to work together.  Team members can collaborate on a single task for the same study with the confidence that they are all accessing the latest data.  Sponsors, CROs, Sites and other vendors can also collaborate to share the responsibility of keeping study tracking data up to date ensuring quality, compliance and readiness.
By integrating data and automating clinical workflows with visual dashboards and providing centralized issue management, all stakeholders have visibility and power to manage all trial activities in a single system. This makes it easier for conducting decentralized (virtual) trials, reducing variation in data collection, enhancing safety signal detection, easing the burden on your sites, and making it more appealing for patients to remain engaged, resulting in faster trials to speed time to market.
“Improved oversight to deliver your trial on time and on budget.”

CQ Clinical Benefits

Increase Visibility and Gain Insight throughout the Clinical Lifecycle

  • Gain a single source of truth about the overall health and effectiveness of your clinical trials
  • Reduce dependency on manual methods of pulling trial-critical information
  • Easily monitor and gain complete visibility and control over all clinical processes
  • Improve clinical data access from anywhere, any device
  • Increase organizational/process communication and transparency across CRO, sponsor, sites
  • Make effective decisions based on real-time insight of clinical data

Accelerate Go-to-Market

  • Accelerate clinical data capture with real-time centralized solution
  • Quickly resolve patient queries to improve patient loyalty and confidence
  • Gain greater efficiency by getting things right the first time
  • Unite and collaborate teams across your clinical trial
  • Reduce costly delays due to data silos, human errors, and cycle times
  • Increase efficiency and economies of scale by eliminating redundancies in your clinical practices and procedures

Risk Reduction

  • Minimize risk through change traceability across the organization
  • Reduce the likelihood of a major non-compliance event
  • Instill a culture of risk-based thinking into your entire clinical ecosystem
  • Keep clinical processes repeatable to increase knowledgeable staff and reduce human error
  • Ensure quality standards are being met throughout your clinical trial
  • Predictive analysis of data reduces potential disruptions to stay on time and under budget.

Stay Compliant and Audit Ready

  • Improve site/study management aligned to amendments, protocol, subject deviations, and staff credentials
  • Increase competence to deal with new regulations
  • Improve visibility over trial compliance gaps and easily convert into corrective and preventative actions
  • Ensure on-time adverse event reporting
  • Quickly search and retrieve content for inspection readiness

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