Accelerate Study Start-up. Activate Sites Faster. Launch With Confidence.

Cloudbyz Study Start-up turns feasibility, regulatory, contracts, vendor readiness, and site activation into one connected workflow — so clinical teams reduce cycle time, eliminate delays, and stay inspection-ready from day one.

Standardize startup milestones across countries and sites

Track contracts, regulatory, vendors, and readiness in one place

Built-in evidence and audit trails for inspection readiness

Trusted by Top Companies

Study Start-up Is Still Where Clinical Operations Loses Time and Control

Even with CTMS, eTMF, and document systems in place, study start-up remains fragmented. Work happens across email, spreadsheets, shared drives, and disconnected vendor portals — creating delays that cascade into enrollment, timelines, and cost.

What Cloudbyz Study Start-up Delivers

Cloudbyz is designed to make study start-up measurable, repeatable, and scalable — across studies, countries, sites, and partners.

Faster site activation and reduced startup cycle time

Real-time visibility across countries, sites, and vendors

Fewer handoff errors and less rework

Better predictability for enrollment and timelines

Stronger inspection readiness through evidence-backed execution

Scale start-up without scaling headcount

More Than Tracking — Study Start-up as an Execution System

Most tools track start-up status. Cloudbyz executes it.

Cloudbyz Study Start-up standardizes key startup milestones to ensure consistent and structured execution across studies.
It automates workflows to streamline processes and reduce manual coordination efforts.
The system captures and maintains documented evidence to support readiness and compliance.
Fully unified with Cloudbyz CTMS and the broader Cloudbyz eClinical platform, it creates a single source of truth for study readiness.

Core Capabilities

Milestone Packs, Dependencies & Readiness Scoring

Standardize What “Ready” Means — Across Every Country and Site

Cloudbyz replaces inconsistent startup trackers with structured milestone packs aligned to your SOPs. Teams can define readiness once, reuse it across studies, and scale globally without reinventing the process.

Includes:

Country and site milestone templates
Dependency logic (parallel vs blocking tasks)
Readiness scoring (Green / Yellow / Red)
Portfolio dashboards across studies, countries, and sites

Milestone Packs, Dependencies & Readiness Scoring

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Site Feasibility, Profiling & Selection

Faster Feasibility With Data-Driven Site Selection

Cloudbyz enables sponsors and CROs to run feasibility and site profiling at scale. Capture structured responses, compare sites consistently, and make faster selection decisions with confidence.

Includes:

Configurable feasibility questionnaires
Site profiling and capabilities tracking
Site scoring models (experience, capacity, performance)
Historical site performance and reuse of preferred sites

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Contract & Budget Workflow Tracking

Make Contracts and Budgets Visible — Without Slowing the Team

Contract and budget negotiation is one of the biggest sources of activation delays. Cloudbyz brings CTA and budget workflows into the start-up execution layer so teams can see bottlenecks early and keep timelines realistic.

Includes:

CTA and budget status workflows
Redline and negotiation cycle tracking
Approvals, escalations, and audit history
Capture key terms and payment triggers

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Regulatory Submission & Approval Tracking

Manage Regulatory and Ethics Readiness as a Controlled Process

Cloudbyz centralizes IRB/EC submissions and regulatory approvals so teams always know what has been submitted, what is approved, what is expiring, and what is blocking activation.

Includes:

Central vs local IRB/EC tracking
Country regulatory authority submissions
Approval expiry, renewal, and amendment tracking
Submission completeness checks and evidence capture

Regulatory Submission & Approval Tracking

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Vendor Readiness Coordination

Bring Vendor Start-up Into One Control Plane

Start-up timelines are often delayed by vendors: labs, imaging, IRT, logistics, and eCOA. Cloudbyz tracks vendor deliverables in the same readiness model so you can coordinate across all parties with shared accountability.

Includes:

Vendor onboarding checklists and milestones
Lab, imaging, IRT/RTSM, eCOA, and logistics readiness
Shared views across sponsors, CROs, and vendors
Delay tracking and escalation workflows

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Site Onboarding & Training Readiness

Ensure Sites Are Truly Ready to Enroll

A site is not ready because an approval exists — it is ready when staff, training, systems access, and documentation are complete. Cloudbyz helps teams standardize onboarding and capture readiness evidence.

Includes:

Site training checklists (protocol, GCP, EDC, IRT, safety)
Training completion evidence capture
Staff roster and role readiness
Activation gating logic based on readiness

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Essential Documents & Inspection Readiness

Build Inspection Readiness Into Start-up — Not After

Cloudbyz captures evidence as part of the workflow. Every milestone can require documentation, approvals, and artifacts — automatically organized and audit-ready.

Includes:

Evidence requirements per milestone
Document versioning and audit trails
“Proof of readiness” summaries by site/country
Continuous readiness instead of last-minute cleanup

Essential Documents & Inspection Readiness

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Activation Forecasting & Bottleneck Analytics

Predict Activation — Don’t Just Report Status

Cloudbyz turns start-up execution data into forecasting and analytics. Teams can see expected activation timelines, top delay drivers, and where intervention will make the biggest impact.

Includes:

Forecasted activation dates by site/country
Cycle-time benchmarking
Bottleneck dashboards (contracts, regulatory, vendors, training)
Executive-ready weekly summaries

Activation Forecasting & Bottleneck Analytics

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AI Agents for Study Start-up

AI Agents That Remove the Manual Work — Without Losing Control

Study start-up is high-volume, document-heavy, and full of repetitive follow-ups. Cloudbyz AI Agents automate the work that slows teams down while maintaining audit trails and human oversight.

AI Agents Included

AI Feasibility Agent

Reviews feasibility responses, flags inconsistencies, and scores sites — accelerating site selection.

AI Start-up Coordinator Agent

Tracks milestone progress, identifies blockers, and nudges stakeholders automatically.

AI eTMF Agent

Automates document intake, classification, metadata capture, and QC validating completeness, flagging gaps, and generating inspection-ready summaries so your TMF team can focus on oversight, not admin.