Resource library
Our regulatory position papers and whitepapers on digital health technologies in clinical trials. Three download without an account; a free account opens the rest after email confirmation and personal approval, usually within one business day. No sales calls attached.
CSV Maintenance — service brochure
Keeping validated systems in a validated state — periodic review, change control and revalidation for computerised systems.
Download PDF →Computer System Validation — service brochure
Computer system validation across the full lifecycle, from validation planning and risk assessment through to execution and reporting.
Download PDF →Data Integrity — service brochure
Data integrity services built on ALCOA+ — governance, gap assessment, remediation and controls across GxP data.
Download PDF →Digital Transformation — service brochure
Digital transformation support for clinical and quality operations — target operating model, process redesign and adoption.
Download PDF →Information Systems Compliance — service brochure
Information systems compliance — bringing IT processes, controls and documentation into line with GxP expectations.
Download PDF →Information Systems QMS Audit — service brochure
Information systems QMS and audit — internal audit, supplier audit and QMS readiness for IT organisations.
Download PDF →Infrastructure Qualification — service brochure
Infrastructure qualification and IT service management — qualifying the platforms and environments that GxP systems run on.
Download PDF →Medical Device Software Development — service brochure
Medical device software development, from planning and requirements through risk management (ISO 14971), development and verification.
Download PDF →Patient Engagement — service brochure
Patient engagement services that strengthen the patient–provider relationship to improve adherence, insight and outcomes.
Download PDF →Quality & Regulatory Assurance — service brochure
Quality and regulatory assurance — QMS design, regulatory strategy and ongoing compliance support for life-science organisations.
Download PDF →Strategy & Thought Leadership — service brochure
Thought leadership, business and project strategy, development and implementation services for life-science companies.
Download PDF →qointa service overview
qointa's full service portfolio across quality management, regulatory compliance, software development, contract research, patient engagement and digital transformation.
Download PDF →A paper raised a question about your study?
The people who wrote these papers run the assessments. Bring the device and the protocol; fifteen minutes is enough to know whether it matters for your trial.
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