Clinical Ops & Data Management
EDC, eTMF, CTMS/RIMS, and Analytics that Power Compliant, Insight-Driven Trials
Celito designs, implements, and operates the clinical systems and data pipelines that keep trials compliant, on‑time, and insight driven - from first‑patient‑in through NDA filing.
Why It Matters
Disconnected EDC exports, ad‑hoc eTMF filing, and Excel‑based study trackers slow decisions and invite findings. Celito unifies your clinical operations stack – EDC, eTMF, CTMS, RIMS, and analytics – so teams see one version of truth and regulators see a clean audit trail.
What We Deliver
EDC & CDMS Implementation
- Vendor selection, URS, and demo orchestration (Medidata Rave, Veeva CDMS, OpenClinica).
- Configuration, UAT coordination, and CSV package (URS → IQ/OQ/PQ).
eTMF & Inspection Readiness
- eTMF platform rollout (Veeva Vault eTMF, MasterControl) with DIA reference model mapping.
- Automated QC workflows and completeness dashboards against TMF maturity metrics.
- Mock inspections and eTMF health checks to maintain constant readiness.
CTMS for Study Oversight
- Global CTMS implementation for site, subject, and milestone tracking.
- Seamless hand‑offs between RA, Clinical, and PV teams.
Clinical Data Warehouse & Analytics
- Centralized data lake ingesting EDC, eTMF, CTMS, CRO feeds, and lab results.
- CDISC‑aligned harmonization (SDTM/ADaM) and real‑time Power BI / Tableau dashboards.
- AI signal finder surfaces enrollment lags, protocol deviations, and safety alerts weeks earlier.
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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Clinical Stack Integration
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Connect EDC, eTMF, CTMS, RIMS, data lake
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Project‑based
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Managed Trial Ops IT
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Operate & enhance clinical systems post go‑live
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Ongoing
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Analytics Accelerator
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Dashboards & signal finder 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).