Clinical Ops & Data Management
EDC, eTMF, CTMS/RIMS, and Analytics that Power Compliant, Insight-Driven Trials
Celito enables clinical programs through standardized clinical platforms, proprietary accelerators, and integrated data architectures that support compliant, on-time, and insight-driven trials from first-patient-in through regulatory submission.
Why It Matters
Disconnected EDC exports, ad-hoc eTMF filing, and Excel-based study trackers slow decisions and increase inspection risk. Standardized clinical platforms (EDC, eTMF, CTMS, RIMS, and analytics) and unified data pipelines provide one version of truth for teams and a defensible audit trail for regulators.
What We Deliver
EDC & CDMS Deployment
- Vendor selection, URS, and demo orchestration (Medidata Rave, Veeva CDMS, OpenClinica) using standardized evaluation frameworks.
- Configuration, UAT coordination, and validation package (URS → IQ/OQ/PQ) supporting GxP compliance.
eTMF & Inspection Readiness
- eTMF platform rollout (Veeva Vault eTMF, MasterControl) with standardized reference model mapping and governance structures.
- Automated QC workflows and completeness dashboards aligned to TMF maturity metrics.
- Ongoing eTMF health checks and inspection readiness activities.
CTMS for Study Oversight
- Global CTMS implementation using standardized study oversight and milestone tracking models.
- Integrated workflows supporting coordinated execution across regulatory, clinical, and pharmacovigilance teams.
Clinical Data Warehouse & Analytics
- Centralized clinical data lake platform ingesting EDC, eTMF, CTMS, CRO feeds, and lab results.
- CDISC-aligned harmonization (SDTM/ADaM) and real-time Spotfire or Power BI or Tableau dashboards.
- Advanced analytics surfacing enrollment lags, protocol deviations, and safety alerts earlier in the study lifecycle.
Compliance & Validation
- 21 CFR Part 11 and GDPR‑aligned data governance.
- GCP validation deliverables and periodic review SOPs.
- Role‑based security, audit logging, and document watermarking.
Our 4‑Step Methodology
Assess
Current‑state process, system, and data flow mapping.
Blueprint
Future‑state architecture, vendor selection, CSV plan.
Implement
Config, integrations, validation, and go‑live enablement.
Advance
Continuous improvement, analytics, and managed support.
Flexible Ways to Engage
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Model
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Typical Use Case
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Commitment
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|---|---|---|
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Clinical Stack Integration
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Connect EDC, eTMF, CTMS, RIMS, and clinical data platforms
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Project‑based
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Clinical Platform Operations
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Operate and enhance clinical systems post go-live
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Ongoing
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Analytics Accelerator
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Rapid deployment of dashboards and signal detection on trial data
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6‑8 weeks
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Proven Outcomes
eTMF completeness scores sustained at >95 % across Phase 2/3 programs.
Clinical data wrangling effort cut by >60 % via AI‑powered ingestion & harmonization.
Portfolio dashboards improve decision cycle time by 30 % for study leadership.
Zero critical findings in FDA and MHRA inspections for supported clients (2024‑2025).