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Let's Meet for Coffee in Barcelona.

Dinesh Kashyap, Founder & CEO of Cloudbyz, is at SCOPE Europe and setting aside time for 30-minute conversations with life sciences executives and clinical operations, regulatory and safety leaders.

Who You'll Meet

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Dinesh Kashyap

Founder & CEO, Cloudbyz

Dinesh is the Founder & CEO of Cloudbyz, where he leads a unified eClinical and Safety platform built natively on Salesforce, alongside a family of AI agents for clinical, regulatory and safety teams. He brings 20+ years across enterprise CRM, life sciences technology and clinical research operations.

He works directly with CEOs and heads of clinical operations, regulatory and safety to move trials from spreadsheet-driven management to real-time, data-driven execution.

  • MIT Sloan
  • Johns Hopkins
  • UC San Diego
  • GCP certified

Worth a Coffee if You Are Thinking About

A few topics on our minds lately. See something you've been thinking about too? Let's talk about it over coffee.

Enhancing Predictability in European Clinical Trial Start-Up

Why EU CTR harmonization still hasn't made multi-country start-up predictable, and where the real bottlenecks hide.

Accelerating European Clinical Trials: Key Strategies to Speed Up EDC Go-Live

The weeks lost after approval to country-by-country EDC builds, translations and validation, and how to win them back.

What Actually Delays Site Activation Across US and EU

Where activation drag builds up when CTMS, finance and eTMF run as separate systems.

6Findings That Show Up Again and Again in FDA and EMA Trial Inspections

The GCP findings that recur most often, and the point at which each one was already catchable.

4 Gaps That Show Up When CRO Oversight Runs on Dashboards Instead of Data

What E6(R3) service-provider delegation means for sponsors whose TMF lives with their CRO.

3 E6(R3) Requirements That Make the Pre-Inspection TMF Scramble Obsolete

With E6(R3) now in effect in the EU, why inspection readiness has to be continuous, not a last-minute clean-up.

About Cloudbyz

The Unified eClinical Platform, Built for Life Sciences

Cloudbyz brings study start-up, CTMS, trial finance, eTMF, EDC, eCOA, RTSM, eRegulatory and safety & pharmacovigilance into one platform. Sponsors, CROs and sites of every size use it to run trials efficiently and bring therapies to patients faster. Separately, Cloudbyz offers AI agents as well: Agentforce copilots for clinical operations and trial finance, and stand-alone agents for TMF, regulatory and safety work.

Serving pharma · biotech · CROs · diagnostics · medical devices · cosmetics & consumer goods

Recognition
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Trusted by Teams At
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ACR
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Electronic Records,Audit Trails &Controlled Access
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HIPAA-Eligible Service Configurations Across The Stack
GDPR compliant
Regional Processing Options & Data Protection Agreements
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Consent, Opt-Out, Quiet Hours & Frequency Governance
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Platform-Level Security Certifications
ICH-GCP-compliant 3
Aligned To Good Clinical Practice Expectations

What Teams are Achieving with Cloudbyz

50% Faster Clinical Reporting

A full-service global CRO replaced its legacy CTMS and siloed tools, connecting its existing EDC and eTMF systems through open APIs.

CTMS · Investigator & Sponsor Portals · DCT

Clinical and Financial Operations, in One Place

A leading biotech brought trial management and budget management together on Cloudbyz CTMS and CTFM.

Device Vigilance, Streamlined

A global medical device leader moved device vigilance onto the Cloudbyz Safety platform.

Safety & Vigilance

Explore Cloudbyz

Cloudbyz AI Agents for Life Sciences

AI RCM Agent-1

AI RCM Agent

Three AI agents that extract, redact and de-identify regulatory content, with every sign-off left to humans.
AI eTMF Agent

AI eTMF Agent

Automates TMF intake, quality and compliance, from drag-and-drop ingestion to inspection-ready filing.
AI RegCheck Agent-1

AI RegCheck Agent

Builds the FDA submission checklist, validates every document and routes exceptions for approval.
Evidence IQ

Evidence IQ Agent

Finds and ranks safety-relevant literature, then turns it into a review-ready case.
AI RegIntel Agent

AI RegIntel Agent

Clear, sourced answers to submission questions in seconds, straight from regulator rulebooks.
AI Protocol Intel Agent

AI Protocol Intel Agent

Reads the schedule of assessments and operational data to flag compliance risks early.
CRA Monitoring CoPilot

CRA Monitoring Copilot

Assembles pre-visit packages and drafts monitoring letters, while monitors make every call.
Financial Navigator Agent

Financial Navigator Agent

A read-only analyst inside CTFM that answers financial questions in real time.
Invoice Reconciliation Agent

Invoice Reconciliation Agent

Reconciles site invoices against proformas in seconds, with humans approving every exception.
AI Case intake Co-Pilot

AI Case Quality Co-pilot

Checks keyed case data against source documents and flags every mismatch, with citations.

Cloudbyz eClinical Solutions

Study start-up

Study Start-Up

Streamlines site selection, feasibility assessments, and helps track regulatory approvals to accelerate trial initiation.
CTMS

CTMS

Trial planning, budgeting and oversight, end to end
CTFM

CTFM

Trial budgets, forecasting and site payments
eTMF

eTMF

Inspection-ready trial documents in real time
EDC

EDC

Data capture built for 21 CFR Part 11, GCP and GDPR
ePRO

ePRO

 Electronically captures patient/clinician-reported outcomes and eDiaries, enhancing data quality.
RTSM

Study Start-Up

Manages trial supplies, drug dosing, inventory tracking, and complex randomization schemes.
Safety & PV

Safety & PV

Case intake to E2B R3 submission, in one system

Take-Home Reading

Case Studies

How sponsors and CROs run on Cloudbyz

AI eTMF Agent Brief

PDF product brief

Product Brochures

CTMS, eTMF, EDC, Safety and more

Whitepapers

Clinical trial technology and best practice

In the News

Leading cosmetics brands partner with Cloudbyz

Can't Make It to Barcelona?

Book a demo and the Cloudbyz team will walk you through the platform on a call.