Clinical Conductor CTMS

Clinical Conductor CTMS offers a training and support program for new users to ensure successful adoption and ongoing effective use of the platform.

Training for New Users:

• 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.

Ongoing Support:

• 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.

• Community Access: New users can join the Onsemble Community to collaborate, share experiences, and gain tips from other Clinical Conductor users and experts.

Clinical Conductor CTMS implements robust security measures to protect sensitive clinical research data, ensuring compliance and privacy for all users and participants.

Security Measures

• 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.

• Disaster Recovery and Backup: Leverages robust backup protocols and disaster recovery planning to ensure data continuity and resilience in case of system failures.

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.

Update Frequency and Management

• 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.

• Support for Adaption: Post-release, users have access to training resources, customer support, and the Onsemble Community to ensure quick adoption and resolve any issues.

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.

Key Points on Data Ownership and Portability

• 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.

• Compliance: The platform’s approach to data ownership and portability aligns with privacy regulations such as HIPAA, GDPR, and 21 CFR Part 11, ensuring both legal compliance and audit readiness.

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.

Key Data Points

• 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.

• Right to Amend Terms: The vendor usually reserves the right to amend terms by providing advance written notice, but clients may have the right to cancel if they do not accept new terms.

Clinical Conductor CTMS meets a broad range of critical compliance standards to ensure data security, regulatory adherence, and participant privacy in clinical research operations.

Key Compliance Standards

• 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).

• 21 CFR Part 11: Complies with FDA standards for electronic records and electronic signatures in clinical studies, supporting audit trails and data integrity for regulated research.