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Establish a clearly defined set of high-level CTMS requirements.
Enlist subject matter experts.
Define a clear implementation strategy for your organization.
Establish training and documentation expectations.
Define what information and standardized templates your team will use during site visits to ensure consistency and efficiency.
Determine the key metrics and KPIs for CTMS reports, and decide how data should be presented for quick, informed decision-making.
Plan for any new or updated SOPs and process guides needed when adopting the CTMS, to maintain quality and integrity in trial operations.
Identify your end-users and their needs. Decide on role-based access levels, mobile app necessity, and ensure the CTMS meets user expectations to drive adoption and productivity.
Outline relevant regulations (e.g., 21 CFR Part 11, GDPR) that the CTMS must comply with, so you can safeguard compliance and your organization’s reputation from day one.
Identify Configuration SMEs: Leverage internal or vendor experts who specialize in CTMS configuration. Ensure you have the right people allocated to tailor the system to your study designs and workflows.
Identify QA/Validation SMEs: Engage experts in validation and quality assurance to streamline regulatory compliance. They will help avoid non-compliance penalties, ensure data integrity, and assist in validating the system.
Set clear implementation phases and milestones. Ensure everyone knows the ideal timeline and checkpoints to stay on the right path, enabling smoother project management with minimal disruption.
Determine if and what legacy data to migrate. Outline which studies, sites, contacts, and records (e.g., protocol deviations) will be imported into the new CTMS, and plan this early to avoid missing critical information.
Decide how you will introduce the CTMS to users – for example, piloting with a subset of users or regions first to mitigate risk, then expanding. This ensures better user adoption and allows adjustments before full-scale launch.
Account for integration with other systems. List any systems (EDC, IXRS, eCOA, finance/HR, eTMF, etc.) that should interface with the CTMS. Early integration planning guarantees seamless data flow and prevents silos.
Define your validation approach. Decide who will conduct validation (internal team or vendor) and ensure the CTMS meets all operational and regulatory requirements. If the vendor offers validation packages, choose the option that best fits your needs for proper execution and documentation.
Identify what documentation (user requirements, configuration specs, SOPs, etc.) needs to be captured during implementation. Ensuring all necessary docs are prepared will facilitate compliance and user onboarding.
Effective training and comprehensive documentation are critical for maximizing the value of your CTMS. You will need to provide job aids, user guides, training videos, and role-based training to support faster user adoption and proficiency with the new CTMS.
Determine whether your internal team will create the training and documentation materials or if you will work with the CTMS vendor’s training and education services to customize the training.
MHRA Inspection Insights: ICH E6(R3) and the Next Chapter of Quality
As regulators adopt the principles of ICH E6(R3), the MHRA is taking a closer look at how organizations apply risk proportionate oversight, quality by design, and documentation that proves control.
No File Left Behind: The Great TMF Migration to Archive
Moving a TMF to archive should be predictable, complete, and auditable.
TMF Inspection Risk Score® Survey | Assess in 10 Minutes
HOW IT WORKS STEP 1 Submit the form to access your survey. STEP 2 Answer questions about commonly overlooked issues that often lead to inspection findings.
