Quality, built into every study.
From study design to delivery, our documented, ISO 9001-certified quality system brings ICH-GCP and ALCOA++ principles into the way evidence is planned, captured and managed.
A quality framework sponsors can work with.
Our approach brings quality, compliance, security and operational continuity into one clear framework for collaboration.
Four foundations under every study.
Quality Management System
A documented QMS governs every study: SOPs, controlled documents, training records, CAPA and continuous improvement, so quality is systematic by design.
ISO 9001 certified
Our quality management is TÜV SÜD ISO 9001 certified and independently audited, across the full study lifecycle, delivered full-service, as FSP, under an ECS® licence or as a consultative engagement.
ICH-GCP & E6(R3)
Studies are designed and conducted to ICH E6(R3) Good Clinical Practice and current EMA/FDA guidance, including for decentralised and hybrid designs.
ALCOA++ data integrity
Data is Attributable, Legible, Contemporaneous, Original and Accurate, Complete, Consistent, Enduring and Available, enforced by ECS® audit trails and e-signatures.
How quality supports every study.
Pharmacovigilance & safety
End-to-end PV and safety monitoring, adverse-event capture, reporting and medical oversight throughout the study lifecycle.
Risk-based quality management (RBQM)
Centralised and remote quality oversight against a documented risk plan, with ViSA surfacing signals early.
D-T-P governed to ICH E6(R3)
Direct-to-Participant execution governed to ICH E6(R3): remote eConsent, decentralised source data, home visits and IMP supply, with data integrity preserved wherever the study reaches the participant.
Audit & inspection readiness
Studies are kept inspection-ready; we host and support regulatory inspections and client audits, with documentation retained per regulation and the CTA.
CAPA & continuous improvement
Deviations and findings are managed through corrective/preventive action, feeding back into SOPs and training.
Validated systems
ECS® is cloud-based and validated to US FDA 21 CFR Part 11, with de-identification, electronic signatures, encryption and comprehensive audit trails.
Independent statistics & reporting
Biostatistics and a Statistical Analysis Plan independent from the sponsor, to CDISC standards, for clear, traceable results.
Built around recognised frameworks.
ECS® and our processes bring recognised data-protection, GCP and security frameworks together across the evidence journey.
- EU Reg. 679/2016 (GDPR)
- HIPAA guidelines
- ICH-GCP
- ALCOA++
- ISO 27001
- US FDA 21 CFR Part 11
- OSSTMM
- OWASP
- NIST 800-115
Your data, protected at every step.
Four operating pillars turn recognised frameworks into consistent data governance across ECS® and every study.
Data ownership & sovereignty
The sponsor owns the data. EU hosting, documented chain-of-custody and guaranteed portability, with a clean exit path from day one.
Privacy by design (GDPR/HIPAA)
Pseudonymisation and data minimisation from capture, granular eConsent, a DPIA per study and DPAs with every processor.
Security controls (ISO 27001)
Encryption in transit and at rest, MFA, role-based access, key management, immutable logging and periodic penetration testing (OSSTMM, OWASP, NIST 800-115).
Audit trail & 21 CFR Part 11
Full ALCOA++ audit trail, electronic signatures, versioning and retention aligned to the Clinical Trial Agreement and applicable regulations.
Certified and independently recognised.
Certificates and our quality policy are available on request. Evidilya is also EcoVadis rated, see Sustainability & CSR and our Code of Ethics.
Quality is a system.
Building your next study?
Tell us what you are planning and explore how our quality framework can support delivery.