Streamlining Biotech Trials with Cloudbyz’s Unified eClinical Platform

In today’s high-stakes biotech environment, clinical development is under immense pressure—shorten timelines, reduce costs, ensure regulatory compliance, and demonstrate value to investors. Yet many biotech organizations, especially early-stage and mid-sized companies, find themselves grappling with fragmented systems, disconnected workflows, and manual processes that slow progress and increase operational risk.

At Cloudbyz, we believe that the key to accelerating clinical trials lies in unifying operations, data, and teams. That’s why we’ve built a comprehensive eClinical platform that integrates CTMS, EDC, and eTMF—designed specifically to empower biotech innovators to streamline trials from study start-up through closeout.

Breaking Down Silos in Clinical Operations

Most biotech companies rely on a mix of tools: spreadsheets for project tracking, emails for communications, separate vendors for EDC and eTMF, and external CRO portals for status updates. This disconnected approach creates:

• Inefficient handoffs between teams

• Data delays and duplication

• Compliance gaps from fragmented documentation

• Limited oversight of study progress and risks

With Cloudbyz’s unified platform, biotech sponsors gain an end-to-end digital environment where trial planning, execution, data collection, and document management live in one place—removing silos and friction from clinical operations.

A Fully Integrated CTMS, EDC, and eTMF—Built on Salesforce

What sets Cloudbyz apart is the native integration across CTMS, EDC, and eTMF modules, all built on the Salesforce platform—renowned for its scalability, security, and configurability. Here's how each module contributes to a streamlined experience:

Clinical Trial Management System (CTMS)

• Real-time dashboards for study milestones, monitoring visits, issues, deviations

• Automated site tracking, document checklists, and monitoring workflows

• Centralized collaboration with CROs and investigators

Electronic Data Capture (EDC)

• Rapid eCRF design without IT support

• Real-time query resolution and source data review

• Integrated data export for analysis, safety, and regulatory use

Electronic Trial Master File (eTMF)

• AI-powered document categorization and completeness checks

• Automated filing and version control

• Inspection-ready dashboards with audit trails and regulatory tagging

This seamless integration ensures that data flows freely across modules, eliminating duplication and manual entry. For biotech teams operating with lean resources, this translates into higher productivity and quality with less overhead.

Accelerating Decision-Making with Real-Time Insights

In biotech, time-to-decision is everything—whether it's selecting the right site, resolving a protocol deviation, or preparing for an interim analysis. Cloudbyz’s unified platform provides real-time visibility into:

• Site activation timelines

• Patient recruitment progress

• Data collection status and queries

• Document completion and compliance

• CRO performance metrics

All of this is accessible through interactive dashboards, configurable reports, and automated alerts. With better data and cross-functional insights, sponsors can make faster, data-driven decisions—and pivot as needed to stay on track.

Enhancing Compliance and Audit Readiness

Regulatory scrutiny is increasing, especially as biotech sponsors pursue global trials and accelerated approvals. Cloudbyz simplifies compliance by:

• Enforcing role-based access and 21 CFR Part 11 compliance

• Tracking all user activity with audit trails

• Auto-generating inspection-ready TMF completeness reports

• Maintaining consistent SOP-aligned workflows across studies

When sponsors, CROs, and sites all operate in the same system, compliance becomes part of the process—not a scramble before inspections.

Designed for Biotech: Agile, Scalable, and Cost-Effective

Unlike legacy systems designed for large pharma, Cloudbyz is built with biotech realities in mind:

• Rapid deployment with minimal IT involvement

• Flexible configurations that adapt to evolving processes

• Pay-as-you-grow pricing to match study scale and budget

• Global accessibility for distributed teams and CRO partners

• Unified support and training across modules

Whether you're preparing your first IND or scaling up for Phase III trials, Cloudbyz evolves with your pipeline and strategy.

The Future of Biotech Trials is Unified

Biotech companies are driving the next generation of innovation—from cell therapies to RNA platforms and rare disease breakthroughs. To bring these complex therapies to market faster and more efficiently, they need a clinical operations model that is connected, intelligent, and compliant.

Cloudbyz’s unified eClinical platform is that model. By bringing together CTMS, EDC, and eTMF in one powerful, user-friendly solution, we empower biotech sponsors to:

✅ Accelerate study timelines
✅ Improve operational oversight
✅ Reduce compliance risk
✅ Scale faster with confidence

Ready to transform how your biotech company runs clinical trials?
Connect with us to schedule a personalized demo of Cloudbyz’s unified platform.