Clinical Research
Validation Platform
GoVal gives clinical research organisations, sponsors, and CROs a single GCP-compliant platform to validate EDC, CTMS, eTMF, and IVRS systems — faster, paperless, and always audit-ready for FDA and sponsor inspections.
What is clinical research validation?
Clinical research validation is the process of providing documented, GCP-compliant evidence that computerised systems used in clinical trials — including EDC, CTMS, eTMF, and IVRS platforms — perform consistently as intended and protect the integrity of clinical data. Required under FDA 21 CFR Part 11, ICH E6 R3 Good Clinical Practice, and EU Clinical Trials Regulation 536/2014, it ensures trial data is trustworthy, audit-ready, and fit to support regulatory submissions. GoVal is a purpose-built VLMS for clinical research teams that digitises this entire process.
Clinical System Validation is Delaying Your Trials
Paper-based validation processes, disconnected quality tools, and inconsistent GCP documentation practices are slowing study startup and creating silent inspection risk.
Study Startup Bottlenecks
EDC and CTMS validation cycles running 8–12 weeks on paper lock out study teams from live systems — delaying first-patient-in dates and compressing trial timelines across every site.
GCP Audit Trail Gaps
Clinical system validation records spread across email chains, Word documents, and shared drives fail ICH E6 R3 audit trail requirements — creating 483 findings and BIMO inspection risk.
Multi-System Complexity
Sponsors manage EDC, CTMS, eTMF, RTSM, and ePRO systems from multiple vendors — each with separate validation documentation and no consolidated oversight for sponsor QA or regulatory inspection.
Protocol Amendments Drive Re-Validation Debt
Every protocol amendment that touches EDC build triggers a re-validation cycle. Without structured change control, teams accumulate undocumented changes that compound inspection risk across multi-year studies.
One Platform for the Full Clinical Validation Lifecycle
GoVal digitises every step of clinical system validation — from URS and risk assessment through IQ/OQ/PQ execution, e-signatures, and Validation Summary Reports — in a single GCP-compliant environment.
GCP-Aligned Validation Templates
Pre-built, customisable URS, risk assessment, IQ/OQ/PQ, and VSR templates for EDC, CTMS, eTMF, IVRS, RTSM, and ePRO systems — reducing scripting effort by up to 60% from the first study.
Paperless IQ/OQ/PQ Execution
Execute Installation, Operational, and Performance Qualification protocols entirely within GoVal — with real-time pass/fail recording, inline deviation capture, and role-based electronic execution across sponsor, CRO, and vendor teams.
Live Clinical RTM
Every clinical system requirement is automatically traced from protocol URS through risk scoring to test case to test result. The Requirements Traceability Matrix updates in real time — no spreadsheet maintenance, no pre-inspection gaps.
21 CFR Part 11 E-Signatures
Enforce fully compliant electronic signatures for all clinical validation approvals — with meaning statements, role-based identity verification, and tamper-evident binding to the signed record. Eliminates wet-ink routing and DocuSign workarounds.
Structured Change Control for Protocol Amendments
Every EDC build change or system update triggers a controlled change management workflow — with impact assessment, re-validation scope determination, and electronic approval chains that document each amendment's validation response.
Sponsor & CRO Oversight Dashboards
Real-time visibility into validation status, open deviations, overdue reviews, and e-signature queues across all clinical systems and trial sites — giving sponsors and CRO QA teams the cross-study oversight ICH E6 R3 demands.
Every Clinical Trial System. One Validation Platform.
GoVal provides purpose-built validation templates and workflows for every major clinical trial computerised system category — reducing time-to-validate from months to weeks.
Electronic Data Capture
EDC · eCRF · Data Management
Clinical Trial Management
CTMS · Site Management · Milestones
Electronic Trial Master File
eTMF · Document Management · ICH E6
IVRS / IWRS / RTSM
Randomisation · Supply Management
ePRO / eCOA Systems
Patient-Reported Outcomes · Clinical Outcomes
Safety Reporting Platforms
SUSAR · SAE · Pharmacovigilance Systems
Faster Trials. Stronger Compliance. Fewer Inspection Findings.
Reduce EDC and CTMS validation cycles from 8–12 weeks to 3–5 weeks — accelerating study startup and protecting timelines across all sites from day one.
Validation documentation, audit trails, and e-signature records are available for FDA Bioresearch Monitoring (BIMO) inspection at any time — never rebuilt weeks before an announced visit.
When protocols change, GoVal's change control workflows automatically determine re-validation scope, generate impact assessment documentation, and route approvals — eliminating the undocumented change backlog that accumulates on paper-managed studies.
Sponsors managing validation across multiple CRO partners gain centralised dashboards showing clinical system validation status, open deviations, and periodic review schedules — satisfying ICH E6 R3 vendor oversight obligations without manual reporting.
Built for Every Clinical Regulatory Framework
GoVal operationalises compliance with every major regulation governing clinical trial computerised systems — globally.
21 CFR Part 11
Electronic records and signatures for FDA-regulated clinical trials. GoVal satisfies all Part 11 technical requirements — audit trails, e-signatures, access controls, and system validation — in a pre-validated environment.
ICH E6 R3 GCP
Good Clinical Practice guidelines requiring that trial systems be validated, maintained under change control, and supported by audit trails. GoVal's workflows are structured around ICH E6 R3 Section 5.5 computerised systems requirements.
EU CTR 536/2014
European Union Clinical Trials Regulation requirements for electronic systems used in clinical trial management. GoVal supports EU CTR data integrity and audit trail obligations for EU-based and multi-regional trials.
ISPE GAMP 5 (2nd Ed.)
Risk-based validation methodology classifying clinical software from Category 1 (infrastructure) to Category 5 (custom). GoVal's risk engine applies GAMP 5 classification automatically, generating proportionate validation scope for each system.
FDA CSA Guidance
FDA's Computer Software Assurance guidance applies to clinical trial systems as much as manufacturing. GoVal's critical-thinking, risk-proportionate approach aligns with CSA for clinical IT — reducing documentation overhead without reducing compliance.
ALCOA+ Data Integrity
Clinical trial data must be Attributable, Legible, Contemporaneous, Original, and Accurate. GoVal enforces all ALCOA+ attributes by design across every clinical validation record — supporting both FDA and MHRA data integrity expectations.
Clinical Research Validation — Questions Answered
Direct answers for clinical operations, regulatory affairs, and clinical IT teams evaluating a GCP-compliant validation platform.
What is clinical research validation?
Clinical research validation is the process of providing documented, GCP-compliant evidence that computerised systems used in clinical trials — including EDC, CTMS, eTMF, and IVRS platforms — perform consistently as intended and protect the integrity of clinical data. Required under FDA 21 CFR Part 11, ICH E6 R3 Good Clinical Practice, and EU Clinical Trials Regulation 536/2014, it ensures trial data is trustworthy, audit-ready, and fit to support regulatory submissions. GoVal is a purpose-built VLMS for clinical research teams that digitises this entire process.
Why do clinical trial systems need to be validated?
Clinical systems must be validated because they capture, manage, and transmit patient safety and efficacy data that underpins regulatory submissions. FDA 21 CFR Part 11 and ICH E6 R3 require that such systems be fit for purpose, validated, and supported by audit trails. Unvalidated systems risk FDA 483 observations, complete response letters, and data integrity findings that can delay or invalidate submissions.
What regulations govern clinical research system validation?
Key regulations include FDA 21 CFR Part 11 (electronic records and signatures), ICH E6 R3 Good Clinical Practice, EU Clinical Trials Regulation 536/2014, ISPE GAMP 5 Second Edition, and FDA Computer Software Assurance guidance. GoVal satisfies all of these frameworks in a single, pre-validated platform — applicable to sponsor, CRO, and site-level systems globally.
What clinical systems does GoVal validate?
GoVal provides pre-built validation templates and workflows for Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), electronic Trial Master File (eTMF), IVRS/IWRS/RTSM, electronic Patient-Reported Outcomes (ePRO/eCOA), clinical safety reporting (SUSAR) platforms, and clinical data warehouses — covering every system type in the modern clinical trial technology stack.
How does GoVal support EDC validation?
GoVal manages the complete EDC validation lifecycle — from User Requirements Specification through GAMP 5 risk assessment, IQ/OQ/PQ execution, live RTM, Part 11 e-signatures, and one-click Validation Summary Report generation. Pre-built EDC templates reduce scripting effort by up to 60%, and automated traceability ensures every protocol requirement is linked to documented test evidence at all times.
How does GoVal handle protocol amendments and re-validation?
GoVal's structured change control workflows automatically assess the validation impact of every protocol amendment. When an EDC build changes, GoVal identifies affected requirements, generates a proportionate re-validation scope, and routes electronic approvals — preventing the undocumented change backlog that accumulates on paper-managed studies and surfaces during BIMO inspections.
Can GoVal support sponsor oversight of CRO validation activities?
Yes. GoVal's multi-site architecture allows sponsors to maintain a centralised view of all clinical system validation activities — across multiple CRO partners, sites, and studies. CRO teams execute validations within client-controlled workspaces, while sponsor QA has read-access dashboards for real-time oversight without day-to-day involvement in execution.
How quickly can a CRO or sponsor implement GoVal for clinical research?
Most clinical research teams go live with GoVal in 3–6 weeks. GoVal ships pre-validated with vendor IQ/OQ documentation, eliminating the need for a platform validation project before real work begins. Pre-built clinical system templates further reduce configuration time — so teams are executing EDC validations in a compliant environment within weeks of contract signature.