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
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
Trusted by Teams At
Electronic Records,Audit Trails &Controlled Access
HIPAA-Eligible Service Configurations Across The Stack
Regional Processing Options & Data Protection Agreements
Consent, Opt-Out, Quiet Hours & Frequency Governance
Platform-Level Security Certifications
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.
CTMS · 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
Three AI agents that extract, redact and de-identify regulatory content, with every sign-off left to humans.
AI eTMF Agent
Automates TMF intake, quality and compliance, from drag-and-drop ingestion to inspection-ready filing.
AI RegCheck Agent
Builds the FDA submission checklist, validates every document and routes exceptions for approval.
Evidence IQ Agent
Finds and ranks safety-relevant literature, then turns it into a review-ready case.
AI RegIntel Agent
Clear, sourced answers to submission questions in seconds, straight from regulator rulebooks.
AI Protocol Intel Agent
Reads the schedule of assessments and operational data to flag compliance risks early.
CRA Monitoring Copilot
Assembles pre-visit packages and drafts monitoring letters, while monitors make every call.
Financial Navigator Agent
A read-only analyst inside CTFM that answers financial questions in real time.
Invoice Reconciliation Agent
Reconciles site invoices against proformas in seconds, with humans approving every exception.
AI Case Quality Co-pilot
Checks keyed case data against source documents and flags every mismatch, with citations.
Cloudbyz eClinical Solutions
Study Start-Up
Streamlines site selection, feasibility assessments, and helps track regulatory approvals to accelerate trial initiation.
CTMS
Trial planning, budgeting and oversight, end to end
CTFM
Trial budgets, forecasting and site payments
eTMF
Inspection-ready trial documents in real time
EDC
Data capture built for 21 CFR Part 11, GCP and GDPR
ePRO
Electronically captures patient/clinician-reported outcomes and eDiaries, enhancing data quality.
Study Start-Up
Manages trial supplies, drug dosing, inventory tracking, and complex randomization schemes.
Safety & PV
Case intake to E2B R3 submission, in one system
Take-Home Reading
Can't Make It to Barcelona?
Book a demo and the Cloudbyz team will walk you through the platform on a call.
At Cloudbyz, our mission is to empower our clients to achieve their business goals by delivering innovative, scalable, and intuitive cloud-based solutions that enable them to streamline their operations, maximize efficiency, and drive growth. We strive to be a trusted partner, dedicated to providing exceptional service, exceptional products, and unparalleled support, while fostering a culture of innovation, collaboration, and excellence in everything we do.
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