How Cloudbyz Empowers Diagnostics & Laboratory Innovation with Unified eClinical Platforms

As the diagnostics and laboratory medicine industry undergoes a digital revolution, organizations face growing pressure to accelerate innovation, streamline operations, and ensure compliance with evolving regulatory frameworks. From in vitro diagnostics (IVD) and laboratory-developed tests (LDTs) to biomarker-driven companion diagnostics and point-of-care solutions, today’s diagnostics companies must navigate increasingly complex clinical and regulatory landscapes.

Cloudbyz, a unified eClinical platform built natively on Salesforce, is leading the charge in enabling diagnostics and lab innovators to bring products to market faster, more efficiently, and with greater confidence. Here's how.

1. The Need for Digitally Connected Diagnostics Trials

Diagnostics trials differ from traditional pharmaceutical clinical trials in several ways:

• They often involve multiple endpoints, including analytical and clinical validation.

• Trials are distributed across labs, clinical sites, and reference testing facilities.

• Regulatory bodies like the FDA (21 CFR 809), EMA, and under IVDR in the EU demand detailed documentation and traceability.

However, many diagnostics companies still manage trials using spreadsheets, fragmented tools, or generic clinical software not built for the specific needs of lab-based validation studies. These outdated methods hinder collaboration, delay submissions, and increase the risk of compliance issues.

2. Cloudbyz: Built for the Unique Needs of Diagnostics

Cloudbyz’s unified eClinical platform addresses these challenges with a purpose-built, modular suite that integrates Clinical Trial Management (CTMS), Electronic Data Capture (EDC), eTMF, eSource, Randomization and Trial Supply Management (RTSM), and Safety—all in one centralized environment.

Key Benefits for Diagnostics Companies:

• ✅ Study Execution at Scale: Plan, launch, and manage multiple diagnostic trials with reusable templates and configurable workflows.

• ✅ Real-Time Data Collection: Capture lab and site data directly into a secure EDC system, eliminating data transcription errors.

• ✅ Compliance Built-In: Automatically generate audit trails, version control, and SOP tracking aligned with FDA, CLIA, CAP, and IVDR requirements.

• ✅ Connected Processes: Seamlessly link CTMS, EDC, and eTMF to track recruitment, sample handling, document readiness, and site performance—all in real time.

3. Powering Innovation Through Salesforce-Native Architecture

As a Salesforce-native solution, Cloudbyz offers unmatched flexibility, scalability, and security. Diagnostics companies benefit from:

• 🔒 Enterprise-grade security and compliance (HIPAA, GDPR, GxP)

• 🔧 No-code configuration to rapidly adjust workflows for new test protocols

• 📊 Real-time dashboards and analytics to monitor study KPIs, lab performance, and regulatory readiness

For example, a diagnostics sponsor can track every sample’s journey—from subject enrollment and specimen collection through testing, result review, and final submission—all within one unified platform.

4. Accelerating Regulatory Submissions with eTMF & Automation

Diagnostics companies often struggle with regulatory submissions due to scattered documentation and inconsistent tracking. Cloudbyz eTMF enables full lifecycle document management with:

• Metadata-driven automation

• Role-based access and digital signatures

• Intelligent redaction (via Cloudbyz ClinRedact) for public and regulator-specific versions

• Metadata extraction and indexing (via Cloudbyz ClinExtract) for faster document classification and searchability

These features reduce submission preparation time, enhance audit readiness, and ensure confidence during FDA, EMA, and notified body inspections.

5. AI & Automation: Enabling the Future of Diagnostics R&D

Cloudbyz is pioneering AI-driven capabilities to further transform diagnostics innovation:

• 🔍 Automated Protocol Parsing: Extract protocol elements to auto-generate study plans and data entry forms.

• 🧠 AI Agents for trial oversight, deviation tracking, and predictive analytics.

• 📁 Smart Document Management: Classify, redact, and annotate documents automatically.

• 🔬 Adverse Event Automation: Detect and triage lab incidents and device-related events in real-time.

These AI enhancements allow diagnostic R&D teams to focus on science and strategy—not paperwork and process gaps.

6. Real-World Impact: Diagnostic Innovation in Action

Diagnostics organizations using Cloudbyz have reported:

• 40–60% reduction in study start-up time

• 100% inspection-ready documentation from day one

• Over 50% increase in team productivity via centralized data access

• Faster go/no-go decisions with real-time study analytics

Whether managing early feasibility studies or global validation trials, Cloudbyz enables diagnostics companies to execute faster, collaborate better, and submit confidently.

Conclusion: Driving the Future of Diagnostics Innovation

In a world where speed, precision, and compliance define success in diagnostics and laboratory innovation, Cloudbyz empowers companies to operate at the intersection of clinical excellence and digital agility. With a unified eClinical platform tailored to the complex needs of diagnostics research, Cloudbyz ensures that lab innovations translate to market-ready products with maximum efficiency and minimum risk.

As diagnostics companies continue to innovate—from molecular testing to personalized medicine—Cloudbyz stands ready as a trusted digital partner for every step of the journey.