Clinical Conductor CTMS
By Advarra
Clinical Conductor CTMS typical implementation process:
Initial Needs Assessment: Stakeholders identify goals, workflows, and integration requirements to tailor the CTMS setup to the organization’s research and operational needs.
Project Planning & Timeline Design: A detailed implementation roadmap is created with timelines, milestones, data migration plans, and resource allocation assignments.
Configuration & Customization: The CTMS is configured based on organization-specific protocols, including role setup, permissions, templates, and workflow customization.
Data Migration: Existing study, financial, and participant data are securely migrated from legacy systems or spreadsheets into Clinical Conductor.
System Integration: APIs or direct integrations are established with other systems like eReg, EDC/EHR, or financial management platforms to streamline workflows.
Training & Onboarding: Users receive targeted training via workshops, webinars, and documentation to maximize knowledge and user adoption.
Testing & Validation: End-to-end testing is conducted to ensure all configurations, data, and integrations function as required before go-live.
Clinical Conductor CTMS is highly customizable to fit specific business needs, with configurability cited as one of its flagship strengths.
Multiple CTMS Configurations: Clinical Conductor offers multiple, role-specific configurations for research sites, networks, CROs, hospitals, health systems, and sponsors—enabling organizations to tailor the features and workflows to their exact requirements.
Granular Financial Controls: Custom budget snapshots, multiple charge masters, detailed financial tracking, and flexible billing setups adapt to varied financial structures and sponsor arrangements.
Protocol Versioning: Organizations can manage multiple protocol versions and amendments easily, supporting dynamic research environments.
User Roles and Permissions: Role-based setup allows tailoring of access, functions, and dashboards for different teams, sites, and study types.
Workflow and Scheduling Customization: Custom workflow steps and calendar management let organizations define operational processes for distinct study models or therapeutic areas.
Forms, Reporting, and Data Import/Export: The platform allows custom forms, ad hoc and customizable reports, and integration with many external systems for seamless data transfers.
Integration Flexibility: Supports API-level customizations for integrations with eReg, EDC, EHR, document management, financial software, and unique in-house applications.
Activity Tracking and Audit Trails: Customizable tracking and audit logs for compliance and GCP guidance.
Alerts and Notifications: Tailored notification settings for various study events, compliance deadlines, and operational triggers.
Clinical Conductor CTMS offers a training and support program for new users to ensure successful adoption and ongoing effective use of the platform.
Role-targeted Training: Training is tailored to various user roles such as study coordinators, research nurses, data managers, clinical trial administrators, and research site staff, addressing both basic and advanced topics relevant to their responsibilities.
Delivery Modes: Offers both in-person and online training options, with flexibility for individuals or customized group training sessions for organizations. Hands-on and scenario-based learning is emphasized for practical understanding.
Content Coverage: Training covers system navigation, study setup and configuration, participant enrollment and tracking, data entry and management, report generation, compliance workflows, and financial tracking.
Onboarding Resources: Includes access to instructional videos, webinars, comprehensive documentation, and a knowledge base for self-paced learning and reference.
Responsive Customer Support: Support is provided via phone, email, and online helpdesk, with a reputation for resolving most issues quickly, often on first contact.
Dedicated Implementation Assistance: Guidance is given during the initial rollout, including data migration, system setup, and user onboarding, with best-practice recommendations for efficient deployment.
Continuous Product Updates: Users receive frequent updates reflecting industry trends and regulatory changes, with support available to help users adapt to new features.
Clinical Conductor CTMS implements robust security measures to protect sensitive clinical research data, ensuring compliance and privacy for all users and participants.
ISO 27001:2013 Certification: Demonstrates adherence to internationally recognized information security management standards, covering confidentiality, integrity, and availability of data.
SOC 2 Type 2 Certification: Confirms compliance with rigorous standards for security, availability, processing integrity, confidentiality, and privacy in cloud environments.
HIPAA Compliance: Ensures that all patient and participant data is protected in accordance with U.S. healthcare privacy laws, including secure handling of Protected Health Information (PHI).
21 CFR Part 11 Compliance: Supports regulatory requirements for electronic records and signatures in clinical research, aiding auditability and regulatory acceptance.
Cloud Security: Operates within a fully managed, secure cloud environment designed to safeguard data from unauthorized access, breaches, and data loss.
Role-based Access Controls: Restricts system access and data visibility based on defined user roles and permissions, minimizing exposure risks.
Data Encryption: Implements encryption for data at rest and in transit to ensure confidentiality during storage and transmission.
Audit Trails: Maintains comprehensive logs of data access and system activity to enable traceability, compliance auditing, and incident investigation.
Regular Security Updates and Monitoring: Includes ongoing vulnerability assessments, patch management, and security monitoring to detect and address potential threats.
Clinical Conductor CTMS typically releases meaningful feature updates and enhancements every quarter, aligning with clinical industry needs and evolving regulatory requirements. Each release often includes new functionality, performance improvements, and user-experience optimizations.
Quarterly Release Cycle: New functionalities, compliance features, and workflow improvements are launched approximately every quarter, but urgent patches and minor updates may occur between major releases.
Advance Communication: Users and organizations are notified in advance about upcoming releases, changes, and new features to allow time for review and preparation.
Testing & Documentation: Updates are accompanied by thorough release notes, user guides, and documentation. New capabilities undergo internal and selected customer testing before full deployment to ensure stability and quality.
Seamless Rollout: Cloud-based deployment allows for smooth rollouts across all client organizations with minimal disruption to ongoing studies or operations.
Clinical Conductor CTMS’s data ownership and portability policy ensures that organizations (such as sponsors, CROs, or research sites) retain ownership and control over their study and patient data stored within the platform. The data is considered the property of the client—the entity managing or running the clinical trial.
Data Ownership: Clinical Conductor CTMS users (e.g., sponsors, CROs, or sites) are the controllers and owners of all patient and study data entered into the platform. Advarra, the provider, acts as a processor and does not claim ownership over customer data.
Contractual Clarity: Duration of data retention and responsibilities for personal information are explicitly defined in the contract with each customer, ensuring that customers govern how their data is used, retained, and eventually purged.
Data Retention: Patient and study data are retained for the period specified in the contract or as required by applicable law or regulation. Once the contract ends or the regulatory period expires, all identifiable data is securely and permanently deleted from the system.
Access Controls: Access to data is strictly regulated by robust, role-based permissions, ensuring only authorized personnel from the client organization can view or manage the data.
Data Portability: Clinical Conductor CTMS supports data import/export and third-party integrations through well-documented APIs and data transfer tools, enabling organizations to extract their data in standard formats should they change platforms or need to fulfill regulatory/data portability requests.
Cloud Security: Data is always stored securely on Advarra-managed, SOC 2-certified cloud infrastructure, with clear policies for data transfer, backup, and restoration.
Clinical Conductor CTMS contract renewal and cancellation terms are generally defined in the agreement between the client and the vendor, and reflect industry standards for clinical trial management software.
Renewal Terms: Most Clinical Conductor CTMS contracts are annual or multi-year (often 1–3 years).
Automatic Renewal: Contracts may include automatic renewal clauses unless terminated by either party through written notice before the end of the current term.
Cancellation Notice: Either party may usually terminate for convenience with written notice—often a minimum of 30 days in advance.
Outstanding Payments: Upon termination, the customer must pay any accrued but unpaid fees, and unsettled balances for services delivered up to the effective cancellation date.
Return of Confidential Information: Each party is required to return all confidential information belonging to the other party upon contract termination.
Data Handling: Data and system access will be terminated on the effective cancellation date, and all client data will be deleted or returned in compliance with contractual, legal, and regulatory requirements.
No Early Termination Penalties (SaaS model): For SaaS or dedicated hosting scenarios, some vendors (including Clinical Conductor CTMS) may not require lengthy minimum terms, offering more flexible subscription cancellation options.
Business Associate Agreement (BAA): For contracts involving PHI under HIPAA, cancellation or non-renewal terms will also reference the related BAA.
Surviving Provisions: Confidentiality, intellectual property, liability limitations, and any unsettled payment provisions remain enforceable even after cancellation.
Customization/Service Fees: Custom integrations or features delivered during the contract are typically not refunded if the contract is cancelled before completion.
Clinical Conductor CTMS meets a broad range of critical compliance standards to ensure data security, regulatory adherence, and participant privacy in clinical research operations.
ISO 27001:2013: Adheres to internationally recognized standards for information security management systems, covering confidentiality, integrity, and availability of sensitive data.
SOC 2 Type 2: Fulfills requirements for secure and trustworthy cloud operations, including security, availability, processing integrity, confidentiality, and privacy.
HIPAA: Ensures protection of patient health data in alignment with U.S. healthcare privacy laws and regulations regarding Protected Health Information (PHI).
