Salesforce Life Sciences Cloud (LSC) gives biopharma, medtech, and diagnostics organizations a powerful engagement and data foundation. Cloudbyz complements it with deep, natively integrated eClinical applications—CTMS, eTMF, EDC/eCRF, ePRO/eCOA, RTSM, Safety & Pharmacovigilance, and Clinical Trial Financials (CTFM)—to close the last-mile gap between engagement workflows and regulated clinical execution.
Together, LSC + Cloudbyz deliver a single, composable platform where study start-up, site activation, subject management, safety, and inspection readiness run on harmonized data, shared identity, and common AI. The result: shorter cycle times, higher data quality, lower compliance risk, and accelerated time-to-value.
One platform, many roles: Sponsors, CRO partners, sites, monitors, PV teams, and supply managers work in a cohesive environment instead of juggling disconnected point tools.
End-to-end data continuity: From investigator outreach in LSC to protocol builds in Cloudbyz EDC, to site payments in CTFM and case processing in Safety, the same master data (studies, sites, people, products) flows without brittle integrations.
AI everywhere (governed): Salesforce Agentforce + Cloudbyz AI (Shortcuts, Automation, and Agents) infuse copilots and automations across clinical processes while honoring auditability, access controls, and validation needs.
Regulatory-grade operations: Cloudbyz eClinical is built for GxP with capabilities that support 21 CFR Part 11 expectations, ICH E6(R3) principles, and inspection-readiness across the trial lifecycle.
Speed with safety: Deliver releases faster using Salesforce metadata-driven configuration and Cloudbyz’s configurable study templates, while maintaining validation discipline through risk-based, test-automated approaches.
Engagement & orchestration (LSC):
Feasibility & investigator engagement, KOL & site network management
Patient services & enrollment outreach where relevant
Case intake channels, service workflows, and omni-channel activities
eClinical execution (Cloudbyz):
CTMS: planning, milestones, monitoring visits, issue management, site payments
eTMF: document plan, intake, quality checks, eSignatures, readiness dashboards
EDC/eCRF + ePRO/eCOA: rapid study builds, data capture, edit checks, queries
RTSM: randomization, kit supply, re-supply strategies
Safety & PV: case intake, triage, coding, assessment, reporting (supports ICH formats), signal workflows
CTFM: budgets, grants, amendments, accruals, forecasts, payable automation
Shared services: identity & access, audit trails, data catalog, Data Cloud, analytics, Agentforce/AI, integration services (EHR/EMR via FHIR, labs, IVRS, E2B gateways).
From outreach to activation: Use LSC to segment and recruit investigators; push selected sites to Cloudbyz CTMS for activation. eTMF auto-generates required document packets by country/protocol and tracks completeness and quality.
Automated TMF quality: AI-assisted checks flag missing or misfiled artifacts; readiness dashboards surface bottlenecks by site, country, or vendor.
Expected impact: Fewer back-and-forth cycles, faster green-lighting of SIVs, and earlier FPFV.
Composable eCRFs: Cloudbyz EDC uses validated libraries and rule templates to cut build time and reduce UAT rework.
eCOA/ePRO baked in: Instruments and schedules deploy alongside EDC, eliminating third-party orchestration hassles.
Expected impact: Shorter build/validate cycles, cleaner day-one data, and reduced vendor coordination risk.
CRA Copilot: AI Agents summarize source data trends, recommend targeted SDV/SDS, and pre-populate visit notes.
Issue-to-resolution loop: CTMS issues convert to actions with SLA tracking and cross-link to eTMF and EDC queries.
Expected impact: Fewer monitoring days onsite, faster query turnaround, and data quality improvements visible in real-time dashboards.
Unified intake: Cases land via LSC channels (medical information, patient services, field reps) and are routed into Cloudbyz Safety for triage.
AI-assisted case processing: NER-based extraction, dictionary coding assistance, causality consistency checks, and submission package assembly with audit trails.
Expected impact: Lower cycle times from intake to submission, consistent narratives, and robust compliance evidence.
Budget intelligence: CTFM models budgets by country/arm/visit and aligns accruals to actual EDC data.
Automated payables: Milestone and per-visit triggers flow to finance systems; sites get timely, transparent payments.
Expected impact: Forecast accuracy, fewer payment disputes, and stronger site relationships.
Continuous readiness: eTMF heatmaps, auto-QC, and completeness scoring; CTMS audit logs tie actions to users and timestamps.
Controlled AI: Every suggestion, classification, or action by an Agent is recorded with rationale and versioning for auditability.
Expected impact: Reduced “war room” lift, smoother inspections, and defensible compliance posture.
AI Shortcuts (in-flow boosts):
Generate visit reports with structured findings; draft monitoring follow-ups; propose TMF filing locations.
AI Automation (hands-off tasks):
Auto-classify and route incoming documents; pre-reconcile CRF–SDV discrepancies; pre-populate payment events from visit data.
AI Agents (goal-driven copilots):
Study Builder Agent: Assembles eCRF and edit checks from protocol synopsis + library patterns.
CRA Copilot: Plans visit focus areas, summarizes deviations, creates corrective actions.
TMF Quality Agent: Monitors completeness, runs periodic QC, and opens CAPAs if thresholds drift.
Safety Intake Agent: Normalizes narratives, suggests coding, and drafts submission artifacts.
Finance Forecast Agent: Projects accruals and flags burn-rate anomalies by site or country.
All AI features are designed to respect GxP validation boundaries, with explainability, access control, and rollback/versioning.
Operational dashboards: Enrollment velocity, query aging, TMF quality, monitor productivity, kit stockouts, budget vs. actuals.
Advanced analytics: Country startup benchmarking, protocol complexity vs. data queries, risk indicators for on-time LPO.
Data Cloud advantage: Harmonize subject, site, product, and HCP data from LSC and Cloudbyz into a governed lake for modeling, forecasting, and AI training—without copy-sprawl.
Clinical & safety data: Lab interfaces, eCOA devices, eConsent, imaging—ingested to EDC/CTMS with lineage preserved.
Healthcare connectivity: FHIR-based exchange with EHRs/EMRs where applicable to streamline eligibility and follow-up.
Regulatory exchange: Safety case formats aligned to ICH E2B standards and regional reporting requirements.
Enterprise finance/ERP: Straight-through posting of accruals and payments; vendor master alignment.
Risk-based CSV: Align implementation to ICH E6(R3) principles, GAMP 5 risk evaluation, and 21 CFR Part 11 controls (identity, eSignatures, audit trails, data integrity).
Validation as a lifecycle: Requirements traceability, OQ/PQ evidence, change control for releases, and test automation to keep pace with frequent, low-risk updates.
Least-privilege access: Profile/permission set strategy spanning LSC and Cloudbyz modules; field-level and record-level controls for sponsor/CRO/site personas.
Value mapping & scope: Pick two high-leverage flows (e.g., site activation + TMF, or EDC build + monitoring). Define KPIs (startup days, TMF QC rate, query cycle time, payment lag).
Data model alignment: Map LSC objects (accounts, HCPs, sites) to Cloudbyz study/site/subject/product models; define the system of record per entity.
Composable configuration: Use Cloudbyz study templates, CRF libraries, workflow rules, and LSC flows/OmniScripts to codify best practices.
Validation runway: Build a risk-based validation plan with automated regression packs; establish release cadences and change control.
AI enablement guardrails: Turn on specific Shortcuts/Agents where evidence and SOPs are ready; log and review AI actions for early assurance.
Adoption & training: Role-based training for CRAs, CTAs, data managers, PV staff, and finance; use in-app guidance and checklists.
Measure & iterate: Instrument dashboards to show KPI movement; expand into RTSM, Safety, or CTFM once the first wave is stable.
Faster cycle times: Accelerated site activation and FPFV, faster query resolution, and shorter case submission timelines.
Higher quality & readiness: Continuous TMF completeness/QC, traceable monitoring, and auditable AI assistance.
Financial control: Accurate, near-real-time accruals and on-time site payments that strengthen relationships.
Lower integration risk: Fewer vendors to validate, fewer interfaces to maintain, and fewer data silos to reconcile.
Happier teams: Role-aware UIs, embedded guidance, and AI that takes the busywork out of scientific workflows.
If you’re LSC-first: Add Cloudbyz CTMS + eTMF to turn investigator and site engagement into activated sites and inspection-ready documentation; follow with EDC/eCOA.
If you’re EDC-first: Layer LSC over Cloudbyz to supercharge recruitment, patient services, and field workflows; bring Safety and CTFM online next.
If you’re PV-first: Start with Safety integrated to LSC case intake; expand to CTMS/eTMF for end-to-end traceability from event to action.
Clinical operations demand both breadth and depth: broad engagement and data capabilities from Salesforce Life Sciences Cloud and deep, regulated eClinical execution from Cloudbyz. By combining them on a single, composable platform—with shared data, shared AI, and shared governance—sponsors and CROs can move from siloed tools and manual workarounds to a unified, inspection-ready engine that accelerates every study milestone.