Revol LIMS delivers multi-sponsor study management with configurable data segregation, sponsor data transfer and regulatory submission package generation, GxP-aligned audit trail and data integrity management, and built-in ICH E6 GCP, OECD GLP, 21 CFR Parts 11/58, and CDISC compliance — in one platform built for the contract research business model.
Contract Research Organisations support the drug development programmes of multiple pharmaceutical, biotechnology, and agrochemical sponsors simultaneously — each with their own protocols, data requirements, regulatory submission targets, and confidentiality obligations. Three challenges define the CRO laboratory environment:
Revol LIMS provides configurable, sponsor-specific data access controls that enforce complete information barrier between concurrent sponsor studies with role-based visibility restricted to contracted studies, data categories, and reporting formats
Revol LIMS generates sponsor-ready data transfer packages formatted to each sponsor’s regulatory submission requirements directly from validated GxP-compliant analytical data.
Revol LIMS maintains ALCOA+-compliant data integrity controls across all CRO laboratory operations — with the immutable audit trail, electronic signature workflows, and sponsor audit support tools that pharmaceutical quality auditors and regulatory agencies both expect from a GxP-compliant contract research organisation.
Revol LIMS manages biological sample chain-of-custody across CRO laboratory sites from clinical site or investigator collection through CRO receipt, analysis, and long-term archiving.
Across bioanalytical CROs, nonclinical contract laboratories, and clinical pharmacology service providers, the same recurring challenges create sponsor relationship risk and regulatory inspection exposure:
Without configurable information barriers, the risk of cross-sponsor data exposure in shared system environments creates intellectual property, confidentiality, and regulatory compliance risk that sponsor audits routinely identify.
Assembling CDISC-formatted data transfers, raw data archives, and audit trail exports that meet each sponsor’s specific regulatory submission requirements manually requires specialist bioinformatics resources and creates submission deadline risk.
CRO studies running across bioanalytical, toxicology, and clinical pharmacology sites with different systems create sample tracking gaps, result consistency issues, and audit trail discontinuities that surface during sponsor audits and regulatory inspections.
When a pharmaceutical sponsor conducts a quality audit of a CRO, they expect to examine the complete study audit trail, data segregation controls, and data integrity evidence for their specific studies in real time — on demand, during the audit itself.
Maintaining GLP-compliant study validation documentation and FDA/EMA-aligned bioanalytical method validation packages for multiple concurrent sponsor studies through shared spreadsheets creates version-control failures that surface as data integrity observations at inspection.
When a sponsor issues a protocol amendment, propagating the change to every affected analyst, instrument, and SOP across a multi-site operation manually creates implementation gaps that become protocol deviation findings.
CRO laboratories face compliance obligations spanning every major GxP framework and the specific regulatory submission requirements of sponsor target agencies worldwide. Revol LIMS provides a single configurable platform that meets sponsor data integrity expectations and regulatory inspection standards.
| ISO 20387:2018 (Biobanking) | How Revol LIMS Supports Compliance |
|---|---|
| ICH E6 (R2/R3) GCP | Trial sample chain-of-custody, specimen handling procedures, laboratory personnel qualification records, and quality management documentation aligned to Good Clinical Practice for CRO laboratories supporting clinical development programmes. |
| OECD GLP Principles | Study management, raw data archiving, sponsor notification, audit trail, and personnel qualification documentation aligned to Good Laboratory Practice for nonclinical regulatory studies submitted to FDA, EMA, and international agencies. |
| 21 CFR Part 11 | Immutable, time-stamped electronic audit trails, role-based access controls, and compliant electronic signature workflows for FDA-regulated CRO laboratory data delivered as part of sponsor regulatory submissions. |
| 21 CFR Part 58 (GLP) | Study management, raw data, and audit trail documentation aligned to FDA GLP regulations for nonclinical pharmacology and toxicology studies submitted as part of IND, NDA, and BLA applications. |
| EMA GCP/GLP Requirements | Laboratory data integrity, audit trail, and record management practices aligned to EMA GCP and GLP requirements for CRO studies supporting European regulatory submissions. |
| CDISC CDASH / SDTM | Configurable data export templates aligned to CDISC CDASH data collection standards and SDTM submission datasets for sponsor data transfers supporting FDA eCTD, EMA CTD, and PMDA eCTD laboratory data packages. |
| FDA Bioanalytical Method Validation (2018) | Configurable validation experiment templates and acceptance criteria aligned to FDA Guidance for Industry: Bioanalytical Method Validation (2018) for PK, immunogenicity, and biomarker assays conducted at CRO bioanalytical facilities. |
| ISO/IEC 17025:2017 | Method validation, measurement uncertainty, equipment calibration, and proficiency testing documentation for CRO laboratories also seeking or maintaining ISO 17025 accreditation for analytical testing services. |
| ALCOA+ Data Integrity | All CRO laboratory data is Attributable, Legible, Contemporaneous, Original, and Accurate — with immutable audit trails satisfying FDA, MHRA, EMA, and PMDA inspectors and sponsor quality auditors across every study. |
Provides configurable sponsor-specific data access controls enforcing complete information barriers across concurrent sponsor studies.
Generates sponsor-ready CDISC-formatted data transfer packages and regulatory submission data directly from validated GxP data.
Maintains ALCOA+-compliant data integrity controls with immutable audit trail, electronic signatures, and purpose-built sponsor audit access that protects other sponsors’ data.
Manages biological sample chain-of-custody across the CRO laboratory network from clinical site collection through analysis and long-term archiving.
Manages GLP study validation and FDA/EMA bioanalytical method validation across concurrent sponsor studies with configurable acceptance criteria per study.
Surfaces intelligence that protects sponsor satisfaction, data integrity performance, and regulatory submission readiness across the CRO study portfolio.
| Feature | Revol LIMS | Legacy Vendors |
|---|---|---|
| Data Segregation | Configurable - sponsor-specific access controls enforcing complete information barriers across concurrent studies by design. | Shared system environments with manual access management; cross-sponsor data exposure risk identified in sponsor audits. |
| Sponsor Audit Readiness | Purpose-built — sponsor audit access mode: study-specific read-only entry with full audit trail export — no other sponsor data exposed. | Audit preparation requires manual data extraction from multiple systems; data segregation relies on procedural controls that auditors routinely challenge. |
| Sponsor Data Transfer | CDISC SDTM-formatted — packages, raw data archives, and audit trail exports generated directly per sponsor specification. | Manual data assembly and format conversion requiring specialist resources; submission deadline risk at every delivery. |
| Data Integrity (GxP) | Immutable : Part 11-compliant audit trail, electronic signatures, and data integrity review dashboards spanning all studies and sites. | Spreadsheet records with shared login and no systematic audit trail; recurring FDA 483 and sponsor audit observations. |
| Multi-Site Management | Unified platform — across all CRO laboratory sites with consistent data structure, sample tracking, and sponsor data segregation. | Site-specific systems with incompatible formats; sample tracking gaps surface in sponsor oversight audits. |
| Implementation Time | 3–4 Months — with GxP-validated implementation methodology aligned to sponsor and regulatory inspection expectations. | 9–12+ Months with custom configuration and validation documentation effort. |
Revol LIMS gives Contract Research Organisations the platform infrastructure to enforce sponsor data segregation without compromise, pass sponsor quality audits with confidence, deliver CDISC-formatted data packages on schedule, and maintain ALCOA+-compliant data integrity across every GxP framework — satisfying sponsor quality auditors and regulatory inspectors at every visit.
“Ready to modernise your CRO laboratory operations? Book your FREE no-obligation demo today.0”
Revol LIMS provides configurable, study-level access role matrices that restrict each user’s data visibility to the specific studies, data categories, and reporting formats they are authorised to access. No user can access another sponsor’s data, samples, or study documentation without explicit authorisation, and confidential data interlocks prevent sponsor-identifiable information appearing in cross-study operational reports.
Revol LIMS provides a purpose-built sponsor audit access mode that grants read-only, study-specific access to sponsor quality auditors — showing them the complete, immutable audit trail for every data entry, modification, and approval on their studies; the data segregation controls preventing access to other sponsors’ data; personnel qualification records; instrument calibration documentation; and method validation and QC performance history — all in one system, without exposing any other sponsor’s data. On-demand audit trail exports by study, analyst, date range, and data category can be generated immediately during the audit itself, removing the manual preparation burden that typically precedes a sponsor audit.
Yes. Revol LIMS supports configurable sponsor-specific data transfer templates in CDISC SDTM, CSV, SAS transport, and XML formats. FDA eCTD, EMA CTD, and PMDA eCTD-compatible laboratory data packages are generated directly from validated GxP-compliant analytical data, with completeness and format validation pre-checks before delivery.
Yes. Revol LIMS maintains an immutable, time-stamped, user-attributed audit trail for every data entry, modification, and approval. Electronic signature workflows are 21 CFR Part 11-compliant. Data integrity review dashboards with anomaly detection support routine audit trail review as required by FDA and MHRA data integrity guidance.
Yes. Revol LIMS manages biological sample chain-of-custody across the CRO laboratory network from clinical site collection through multi-site receipt, analysis, inter-site transfer, and long-term archiving, with sponsor-specific sample labelling, temperature-controlled transport logging, and sponsor-defined retention policy configuration.
Revol LIMS manages protocol parameters centrally — when a sponsor issues a protocol amendment, changes to analytical parameters, QC acceptance criteria, or sample handling procedures are updated centrally and propagated to all affected study records, analyst configurations, and instrument parameter sets, ensuring consistent implementation across all laboratory sites.
Revol LIMS is available as SaaS (cloud-hosted with validated infrastructure), PaaS, and on-premise deployments. For CROs with specific information security requirements, sponsor data sovereignty obligations, or firewall-protected laboratory IT environments, on-premise and private cloud deployment options are fully supported with GAMP 5-aligned implementation documentation.
