As clinical trials progress and the risk of potential issues within the process rises, organizations are tasked with finding a way to efficiently manage these risks without impacting costs or pushing back schedules. Managers tasked with clinical trial oversight are at the epicenter of analyzing and controlling these evolving risks.Cloud Concinnity® provides invaluable help for clinical trials administrators by centralizing all information securely in the cloud, automating critical compliance processes and pushing critical evaluations and alerts to decision makers.
Cloud Concinnity® equips teams with automated alerts, assessments, collaboration tools, and more, giving them complete control over their data and mitigating risk while helping to ensure they remain compliant.
How Cloud Concinnity® Helps Minimize Risks in Clinical Trials
Clinical trials are essential in ensuring that new treatments and drugs are safe and effective for patients. However, they come with a certain level of risk that can be difficult to manage. That's where Cloud Concinnity® comes in.
From tracking participant information to securely storing trial data, Cloud Concinnity® offers a comprehensive solution to help trial sponsors and their administrators focus on what matters: ensuring patient safety, treatment efficacy and regulatory compliance. With its user-friendly interface and advanced security features, Cloud Concinnity® is poised to transform the way clinical trials are conducted.
Some of our client's favorite risk-management features include:
Centralized Information Management
Workflow Automation
Centralized Meeting Management and Collaboration
Audit-Ready Information Output
Verified Security and Regulatory Compliance
1. Centralized Information Management
With the ongoing digitization of clinical trials, how study data is captured and recorded is undergoing significant changes. This transformation, in turn, has a substantial effect on the way oversight committees assess data. Our cloud-based platform serves as a centralized hub for the clinical trial information governance and oversight ecosystem - streamlining access to necessary tools and making them available from any location through significant web browsers.
Our easy-to-use interface is built to allow study administrators to grant or revoke system access to specific individuals based on their roles. Thus, users can only access the information they need to complete their work.
Role-based access is paired with a robust notification center to inform your team with reminders that can be sent through text and email.
2. Workflow Automation
Cloud Concinnity® uses automated workflows to provide a double-whammy of risk mitigation. First, you can ensure critical tasks and communications are sent out without issue or manual involvement by automating your mission-critical workflows. This helps to free up additional time, allowing your team to focus on other tasks - reducing labor overhead and streamlining operations.
Second, automating repetitive workflows ensures process consistency, which is critical in clinical trials to ensure patient safety and regulatory compliance. Process quality is difficult to control when manual and almost impossible to prove in terms of compliance. Cloud Concinnity virtually eliminates this risk.
3. Centralized Meeting Management and Collaboration
Who hasn't wasted hours trying to schedule a meeting with multiple team members? Cloud Concinnity® is here to help with end to end meeting management
Our robust platform comes equipped with a host of features to help you schedule meetings, including:
Online Meeting Polling Functionalities
Automated Meeting Reminders
Video Conference Integrations
Calendar Syncing
All of these work together to save administrators time while allowing committees (like DMCs) to stay up-to-date with critical updates and mitigate any risk of meetings NOT happening according to protocols, critical timeframes and regulatory requirements.
4. Audit-Ready Information Output
Cloud Concinnity® was built to meet the specific reporting needs of Trial Sponsors CROs and their oversight teams. As such, our platform has push-of-a-button access to information required for external and internal audits.
This functionality includes audit-ready tracking of tasks, messages, role changes, meeting minutes, documents, and critical actions taken and more.! Your team can use the standard or custom eTMF and FDA templates to create audit and compliance documents.
5. Verified Security and Regulatory Compliance
Tools and processes with verified security and regulatory compliance are crucial for clinical trial risk management because it ensures that your organization operates and complies with applicable laws. This compliance also helps to demonstrate the trial organizer's commitment to ensuring the safety and security of its participants, employees, and stakeholders.
Cloud Concinnity® has a host of security and compliance features, including:
Two-Factor Authentication
SOC 2 Attestation
21 CFR Part 11, Annex 11, GDPR and HIPAA Compliance
Risk mitigation in clinical trials is essential for ensuring patient safety and process efficacy. Cloud Concinnity® helps organizations minimize risks with a suite of features built specifically for clinical trial oversight. Learn more about Cloud Concinnity® and schedule a demo today.