A quality system built to be tested
A Risk-Based Quality System, Proportionate to Every Study.
Our quality management system defines how clinical research work is planned, performed, documented, reviewed and improved.
The objective is not uniform control of every task; it is proportionate control of the activities and information that matter to participant protection and reliable trial results.
MDTrials maintains documented quality controls for the clinical research activities it performs. Public descriptions are limited to controls that are effective and auditable. MDTrials CRO and MDTrials Sites operate through separate legal entities, and each entity remains accountable for the procedures, training records, quality records and study responsibilities applicable to its scope. Shared governance or support processes are used only where formally defined.
Risk-based quality management
ICH E6(R3) places explicit emphasis on identifying factors critical to quality, evaluating relevant risks and applying controls proportionate to those risks. MDTrials applies this principle through study-level planning, documented risk assessment, issue escalation and periodic review as the trial evolves. [R17, R20]
Systems ownership
For systems MDTrials owns or configures, assurance is proportionate to intended use and risk. Where a sponsor or vendor provides the EDC, CTMS, eTMF, IRT or another platform, MDTrials does not imply ownership of that system validation. We control our authorised access, training, use, documentation and escalation within the responsibilities assigned to us.
Use of AI
Digital and AI-assisted tools may support administrative or regulatory work only within approved use cases. Patient-identifiable information, confidential trial data is not currently approved unless discussed within the project scope. Where an AI-assisted output contributes to a regulated record or trial decision, a qualified person remains responsible for review and approval.
Training. Delegation. Coordination.
QMS components - publish only when effective
- Controlled SOPs and document lifecycle management
- Role-based qualification and training records
- Study-level quality and risk planning
- Deviation and nonconformance management
- CAPA and effectiveness verification
- Vendor and service-provider qualification and oversight
- Trial master file and essential-document controls within assigned scope
- Audit and inspection readiness
- Management review and continuous-improvement mechanisms where implemented
Continuous improvement
Findings, deviations and audit observations feed a documented improvement process. Recurrent issues are evaluated for system causes rather than treated only as individual errors.
Frequent Questions
- What is risk-based quality management?Identifying which aspects of a trial are critical to participant safety and data reliability, assessing the risks to those aspects, and applying controls in proportion — rather than applying identical intensity to every activity.
- Can we audit your quality system?Yes. Sponsor audit rights are addressed in our services agreements, and we support vendor qualification audits as a normal part of engagement.
- How do you manage protocol deviations?Deviations are identified, documented and assessed for impact on participant safety and data integrity, escalated according to defined criteria, and where required processed through CAPA with effectiveness verification.
- Can a sponsor review our quality system?Yes. Qualification information is provided in proportion to the service being considered and subject to confidentiality controls. Sponsor audit rights, access and scope are addressed in the applicable services agreement.
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Documented, risk-based quality management aligned to ICH E6(R3) — designed to hold up under your own review.