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The AI-Enabled eClinical Platform

The pioneering
AI-enabled eClinical
platform. Data integrity
by design.

EDC. eTMF. CTMS. eConsent. C2TA. One AI-enabled platform from study startup to first clinical study report. Real-time data integrity, integrated trial finance, and minimal-downtime architecture. FDA 21 CFR Part 11 from day one.

Book a 30-Minute Demo See How It Works
50%
Trial time reduced
(IGMCRI)
12 days
150 patients enrolled
(planned: 12 months)
8+
Hospitals in
live trials now
4x
Prix Galien nominee
2022 to 2025
AI Monitoring
0
Anomalies today
C2TA Payment
$48,200
Sent same-day
Trial Progress
78%
Phase II Oncology
EDC C2TA eTMF
Quality by Design
Real-Time Data Capture
21 CFR Part 11
GCP Compliant
ICH E6
eTMF
EDC Software
eSource
End-to-End Hybrid Trials
ePRO
CTMS
Audit-Ready
Data Integrity
Immutable Audit Trail
Sponsor Finance
Minimal Downtime
AI-Enabled Platform
Quality by Design
Real-Time Data Capture
21 CFR Part 11
GCP Compliant
ICH E6
eTMF
EDC Software
eSource
End-to-End Hybrid Trials
ePRO
CTMS
Audit-Ready
Data Integrity
Immutable Audit Trail
Sponsor Finance
Minimal Downtime
AI-Enabled Platform
Data Integrity
Every record cryptographically verified at the moment of capture. GCP compliant by architecture.
21 CFR Part 11
FDA compliance from day one. Not retrofitted. Built into the data layer as a structural requirement.
Minimal Downtime
Distributed architecture with no single point of failure. Proved under conditions no test could simulate.
AI-Enabled
Real-time monitoring built into the clinical data layer. Anomaly detection, risk scoring, financial intelligence.
Validated by
Prix Galien SCOPE 2024 ConV2X First Prize NTT DATA Partner CDISC Member 21 CFR Part 11 HIPAA GDPR

Who This Is For

Do you recognise yourself
in one of these?

The same process problem shows up differently depending on where you sit in a trial.

"We have a drug candidate. We have funding. We cannot spend $50K a month on software."

Bloqcube gives your team one system for every function at a price your trial budget can absorb.

The drug is real. What kills momentum is operations. Five systems that do not talk to each other, a coordinator re-entering data all day, and a CFO with no real-time view of trial spend. Quality by Design requires data to be right at entry - not corrected in reconciliation weeks later.

  • One login for EDC, eTMF, CTMS, eConsent, and integrated finance
  • Live in two weeks - cloud-based, no IT overhead
  • C2TA links patient visits to same-day payment automatically
  • AI layer monitors data quality in real time - no end-of-week surprises
See this on your study
$2.6B
Average cost to bring a drug to market
2 weeks
Typical go-live from contract to first data entry
50%
Trial time reduction vs conventional workflows
2 hrs
Team training vs 3 weeks on legacy platforms

"Eight trials. Five sponsors. A different system for each one. Someone is going to introduce a data quality problem we cannot find until audit."

Bloqcube keeps one verified source of truth across every trial. Real-time processing flags anomalies the moment they occur.

Fragmentation is the core liability in CRO operations. Data integrity gaps accumulate silently. The formal audit finds them 3 to 5 years later. By then they are embedded in regulatory submissions. Bloqcube's real-time data processing means quality gates fire at entry - not at inspection.

  • One platform across all sponsors and all active trials
  • Distributed audit trail flags quality exceptions the moment they occur
  • C2TA automates site, investigator, and patient payments
  • AI predicts site performance risk weeks before it becomes critical
See multi-sponsor operations
75%
Sponsors using 5+ disconnected systems per study
$35M
Lost when an FDA audit found data integrity exceptions
3–5 yrs
Typical gap between data entry error and audit review
Day 1
When Bloqcube real-time processing surfaces anomalies

"My coordinator manages five sponsor portals and re-enters the same patient data three times. Patients keep asking where their payments are."

Bloqcube reduces the load at the point where it actually happens - fewer logins, no duplicate entry, patients paid the same day.

Site coordinators are the backbone of every trial. Multiple logins, duplicate data entry, paper consent forms, and 30 to 45 day payment delays that drive patient dropout. Each of these is a process design gap that Bloqcube addresses at the system level.

  • Two-hour training - not three weeks of onboarding
  • iPad-ready, works offline and syncs on reconnection
  • eConsent fully digital, remote or in-person, complete audit trail
  • Patient payments triggered same day on visit completion
See a live site workflow demo
74%
Sites still paper-based for source data (Florence 2025)
30–40%
Patient dropout driven by payment delays and travel
5+
Sponsor portals a typical coordinator manages simultaneously
Same day
Patient payments vs 30–45 day industry average

How It Works

Four data integrity challenges every trial faces.
Open each card for the fix.

Each card states the data integrity challenge and the documented outcome. Open it to read how Bloqcube addresses it at the system level.

Patient Retention

30–40% of patients drop out before a trial ends. Travel is the main reason.

Outcome: 150 patients completed in 12 days on a study planned for 12 months.

Distance, repeated in-person visits, and 30 to 45 day payment delays drive dropout. Each dropout costs $50K to $200K and creates a protocol deviation.

Bloqcube's hybrid trial capability lets patients participate remotely. eConsent, ePRO, and AE reporting on any device. Real-time data flows directly from patient to sponsor without paper at any step.

Data Fragmentation

Five systems that do not talk to each other create more quality risk than paper ever did.

Architecture: Distributed verified records with no single point of failure. Minimal-downtime under direct infrastructure attack.

Every data transfer between systems is a Quality by Design risk point. Re-entry errors accumulate silently. By the time audit finds them, they are in regulatory submissions.

EDC, eTMF, CTMS, eConsent, and C2TA in one integrated platform. Data does not transfer between tools - it lives in one cryptographically verified record from the moment of capture. Real-time processing, zero reconciliation cycles.

Audit Readiness

A safety signal that takes 48 hours to surface is a regulatory liability, not monitoring.

Compliance: FDA 21 CFR Part 11. GCP. ICH E6. HIPAA. GDPR. From day one.

GCP requires timely AE reporting. Real-time integrity monitoring means anomalies surface immediately - not in end-of-month reconciliation or pre-inspection preparation.

Every entry is cryptographically time-stamped at the moment of capture. Tamper-evident. The AI layer monitors continuously. Quality by Design means the system enforces data standards at entry - FDA inspectors review the audit trail and move on.

Financial Visibility

Patients wait 45 days for payment. Sponsors run budgets on last month's spreadsheet.

Unique: The only platform that connects clinical events to payment in real time. Nothing else does this natively.

Payment delays drive dropout. Budget opacity means financial decisions run on stale data. Clinical operations and finance are completely siloed from each other.

C2TA (patent pending) links clinical activity to real-time payment processing. Visit completed, payment triggered same day. Budget updates live. AI forecasts payment volumes and flags overruns before they occur.

See the full platform breakdown

The Platform

Build your trial stack
module by module.

Choose the modules your study needs today. Slot in more as your trials grow. Every module connects to the same verified data foundation - nothing migrates, nothing breaks, no integration fees between modules.

Start with EDC and eConsent. Add eTMF when you enter Phase II. Layer in CTMS when you go multi-site. Activate C2TA when payment delays start affecting retention. Add the AI layer when you need proactive anomaly detection.

Start here: core compliance
EDC
Start here
eConsent
Start here
Add as you grow
eTMF / eISF
Phase II+
CTMS
Multi-site
C2TA
Retention
Expand further
BloqBridge
Supply chain
AI Layer
Sept 2026
More coming
2026
Electronic Data Capture | EDC Software | eSource
EDC
Real-time data capture at site or remotely. Every entry cryptographically verified at the moment it is made.
Dynamic eCRF forms with conditional logic. Offline capture that syncs on reconnection. Edit checks fire at entry - not in weekly reconciliation. Every entry creates a tamper-evident, time-stamped audit record. FDA 21 CFR Part 11 compliant. Works on iPad, tablet, or desktop. QbD data standards enforced at source.
Electronic Informed Consent | eConsent | Remote Consent
eConsent
Remote or in-person. Audio and written formats. Multi-factor authentication. Time-stamped consent records with full audit trail.
Re-consent workflows. Multi-language. ICH E6 GCP compliant. Works on tablet at bedside or on the patient's device remotely. Full witness and LAR signature flows. Every consent action is cryptographically time-stamped - satisfying FDA electronic signature requirements under 21 CFR Part 11.
Electronic Trial Master File | eTMF/eISF | Regulatory Documents
eTMF / eISF
Regulatory document vault and Investigator Site File (eISF). The documents FDA inspectors check first. Native in the same system as EDC and CTMS - no separate tool, no data bridge.
Not available natively on most platforms
DIA TMF Reference Model compliant. Automated document placement. Version control and edit history on every document. Inspection readiness dashboard. Real-time completeness tracking. Because eTMF shares a verified data foundation with EDC, cross-referencing during inspection is automatic - no manual reconciliation before audits.
Clinical Trial Management System | CTMS | Site Management
CTMS
Site performance, enrollment tracking, milestones, and monitoring visit management. Connected directly to live EDC data - no separate update cycle.
Site activation and investigator qualification tracking. Protocol deviation management. Monitoring visit reports. Real-time enrollment projections built from live EDC data. Per-site budget tracking. No weekly reconciliation meeting to decide which number is right - metrics are always current.
Integrated Trial Finance | C2TA | Patient Payments | Budget
C2TA
Clinical activity triggers payment automatically in real time. Patient completes a visit, payment goes out same day. Budget updates live across the program.
Unique to Bloqcube - patent pending
C2TA (Clinical-to-Trial Activity) connects the clinical and financial layer in real time. Patient completes a visit, C2TA triggers payment via Stripe, CBDC, or configured gateway - same-day settlement. Site payments and investigator fees follow the same logic. Program-level budget updates in real time. No other platform does this natively.
Supply Chain Management | BloqBridge | Drug Accountability
BloqBridge
Investigational product tracking from manufacturing to patient administration. Tamper-evident chain of custody across all sites.
Real-time drug inventory across all sites. Automated dispensing records linked to patient visits in EDC. Returns and destruction tracking. Temperature excursion alerts. Expiry management. Every movement cryptographically verified - a tamper-evident record from manufacturing release to patient administration.
See the platform on your specific trial design
SARA AI  |  Now in Development  |  Sept 2026

Bloqcube AI.
Data integrity enforced
at every step of your trial.

Clinical trials lose time and data quality at invisible gates - data quality thresholds that cross in silence, enrollment rates that miss projections by 11 days, budget lines that overspend before anyone checks the spreadsheet. Bloqcube AI monitors your live trial continuously and flags quality exceptions the moment a threshold is crossed, not after damage is done.

How Bloqcube AI Works
01
Ingest live trial data
AI connects directly to your EDC, eTMF, CTMS, and C2TA in real time. No export, no manual data pull required.
02
Find the gates
AI identifies quality thresholds, enrollment gaps, site risk signals, and budget drift the moment they emerge from the data stream.
03
Battle the process friction
AI surfaces the specific action needed - not just an alert. It proposes the escalation, the query, the site intervention, or the budget reforecast.
04
Close the loop
Every AI action is logged in the verified audit trail. No shadow decision-making. Full GCP compliance and regulatory defensibility at every step.
Data integrity monitoring
Monitors EDC data continuously. Flags protocol deviations, data quality exceptions, and AE signals before they require manual review - at the moment of entry, not end of week.
Enrollment prediction and site risk scoring
Predicts lock dates from current site performance. Identifies underperforming sites weeks before they become critical path problems. Time to intervene, not react.
Regulatory readiness assistant
Natural language queries against your eTMF and EDC. Ask about document completeness, open queries, or inspection readiness. Answers sourced directly from your verified trial record in seconds.
C2TA financial intelligence
Forecasts payment volumes in real time. Flags budget overruns before they occur. Models the financial impact of protocol amendments across all active sites before you approve the change.
Join the Early Access List Read the AI brief
Bloqcube AI - Trial Query Interface
Live
What is the current data query rate on Site 04 and is it affecting our lock timeline?
Site 04 query rate: 8.2% - above the 5% GCP threshold.

At current resolution pace, this delays data lock by 11 days against your Sept 30 target.

3 of the 7 open queries are on the same CRF field - Visit 3, Vital Signs row 4. Likely a field-level logic issue. I can auto-escalate to the site coordinator and flag for a validation check. Proceed?
Yes. Also check if any other sites have the same pattern.
GCP Compliant  ·  21 CFR Part 11
Powered by Bloqcube verified data layer

What We Are Built On

Six principles behind every design decision.

Not features. The structural reasons the platform works the way it does.

Quality by Design at the data layer
Data standards enforced at point of entry - not corrected in reconciliation weeks later.
QbD is an ICH and FDA principle that design decisions should prevent problems rather than detect them after the fact. Edit checks, field validation, and audit trail generation are built into the data capture layer - not applied as compliance overlays later.
Finance is part of the clinical system
C2TA connects clinical activity to real-time payment - because payment delays are a data quality and retention problem.
Patent pending
Patients who are paid on time complete their visits. Patients who wait drop out. Dropout is not just a retention metric - it is a data completeness and protocol deviation risk. Payment is a clinical problem.
eTMF is not optional
Regulatory documents and trial data share a verified foundation. Inspection readiness is automatic, not a preparation exercise.
When eTMF and EDC share the same verified data layer, an inspector's question about a data point is answered in seconds - pulling both the source record and the governing document from the same audit trail with cryptographic proof neither has been altered.
Designed for small and medium-sized life science companies
Most clinical trials are run by small and medium-sized life science companies. Most clinical trial software was built for large enterprises.
Two-hour training. iPad-ready. No IT department required. We did not take an enterprise product and remove features - we built for small teams from the start. The workflows make sense to someone running their first trial.
Minimal-downtime by architecture
Distributed verified architecture means no single point of failure. Proved under conditions no test environment could simulate.
Standard centralised systems require a switchover when the primary fails - that process takes time and loses transactions. Bloqcube's distributed architecture stores data across multiple nodes. When a data center was struck by a direct attack in the Gulf, every active trial continued. Zero data loss. Minimal downtime.
Pricing that does not assume enterprise budgets
We publish our pricing. You know what you pay before the first call. No integration fees between modules.
The number you see is the number you pay. No hidden module connectivity fees, no minimum seat counts, no integration costs between components. If our pricing does not work for your study, we tell you that on the first call - not after a 6-week evaluation.

Case Studies

What happened when real
trials ran on Bloqcube.

Documented outcomes. Click any card to read the full story.

From the Blog

Written by the people
who built the platform.

Practitioners with decades inside pharma and regulatory. Not marketing content.

FDA
FDA | Data Integrity | QbD
Data Integrity, AI Governance and Quality-by-Design Compliance
The FDA 2024 guidance and January 2026 AI principles make one thing clear: data integrity is no longer a GxP checkbox.
PN
Dr. P.K. NarangChief Scientific Officer
Read the full article
Investors
Investors | Market Analysis
Why eClinical Integration Is the Fastest-Growing Segment in Clinical Software
The eClinical integration market grows at 17.54% CAGR. Here is what is driving it and why C2TA sits at the centre.
RR
Rama K. RaoCEO and Founder
Read the full article
AI
AI | Clinical Operations
How AI Agents Are Changing Real-Time Trial Monitoring
AI is not replacing clinical operations - it is processing the data volume that human monitoring cannot keep up with in real time.
BQ
Bloqcube Product TeamAI and Platform Development
Read the full article
See all articles - FDA, Investors, AI, Clinical Operations

Recognised by

Gartner
Named in the Gartner Hype Cycle for Data Integrity in Healthcare
Prix Galien
Best Startup Nominee 2022 to 2025
SCOPE 2024
Clinical Trials Technologies Finalist
ConV2X 2023
First Prize, Verified Data in Healthcare
PM360
Innovators Award 2022, 2023, 2024
HITLAB
Columbia University Validation
NTT DATA
Partner
CDISC
Member

FAQs

Frequently asked questions about the platform.

Bloqcube is an AI-enabled eClinical platform combining EDC, eTMF, CTMS, eConsent, and C2TA integrated trial finance in one FDA 21 CFR Part 11 compliant system. Built on a distributed verified data architecture that ensures real-time data integrity and minimal-downtime operation. Founded 2017, headquartered in Piscataway, New Jersey.
C2TA (Clinical-to-Trial Activity, patent pending) links patient clinical activity to real-time payment processing. Patient completes a visit, C2TA triggers payment via Stripe or CBDC the same day. No 30 to 45 day delays. No manual reconciliation. Payment delays are one of the top drivers of patient dropout - eliminating the delay directly improves retention. No other platform offers this natively.
Data integrity is enforced at the point of entry - not applied as a compliance overlay after the fact. Every record is cryptographically time-stamped when created. Edit checks fire in real time. The audit trail is generated automatically and cannot be altered without creating a visible discrepancy. This is Quality by Design applied to the data layer: the system structure prevents problems rather than detecting them in reconciliation. FDA 21 CFR Part 11 compliant by architecture.
Standard centralised systems rely on a primary server with failover. When the primary fails, a switchover begins - during which transactions can be lost. Bloqcube's distributed verified architecture stores data across multiple nodes simultaneously. There is no primary node to fail. A physical infrastructure attack on a data center in the Gulf left active trials running without interruption. Zero data loss. Minimal downtime.
Most deployments are live within two weeks. Cloud-based means no infrastructure setup. Two-hour team training. No 8 to 12 week enterprise implementation cycle. You can be running eConsent and capturing real-time data while platforms requiring extended configuration are still in kickoff.
Yes. Bloqcube is modular by design. Start with EDC and eConsent for your first study. Add eTMF when you move to Phase II. Layer in CTMS when you go multi-site. Activate C2TA when payment delays start affecting retention. Every module connects to the same verified data foundation - nothing migrates, nothing requires re-implementation, no integration project between modules.
Already using Bloqcube? Visit the Help Centre Have a specific question? Ask us directly in a demo call

Book a Demo

Bring your study.
We walk through it together.

30 minutes. No generic product tour. Bring your trial design and we show you exactly how Bloqcube handles it - which modules your study needs, what it costs, and a realistic go-live timeline.

  • Live platform walkthrough on your trial type and phase
  • Real-time data integrity demonstration on your CRF structure
  • C2TA finance demo on your budget and payment model
  • Module recommendation for your study today vs year two
  • Transparent pricing - everything included, no surprises
  • Go-live timeline specific to your study design
Schedule Your Demo
Pick a time. 30 minutes. No prep required on your end.
Pick a time
Or email: info@bloqcube.com

The People Behind It

Built by people who spent their careers inside the problem.

Not software engineers who studied clinical trials. People who ran them.

RR
Rama K. Rao
CEO and Founder
28 years in pharma. Built Bloqcube because he watched the same operational failures repeat across every trial he oversaw.
28 years across Eli Lilly and Novartis. Ex-CFO Novartis Pharma Canada and Russia. Ex-Global Head of Development Finance, Novartis Oncology. Managed a $3 billion P and L. Presented at JPMorgan Healthcare Conference, SCOPE, and Bio-IT World. Co-leads IEEE AI in Clinical Research standards development.
PN
Dr. P.K. Narang
Chief Scientific Officer
Ex-Head of Novartis Oncology Global Regulatory Affairs. Architected Bloqcube's GCP and data integrity compliance framework.
Decades in clinical development and regulatory strategy across FDA and EMA. Authored the data integrity and AI governance methodology that Bloqcube's platform is built on. PhD and FCP credentials.
AC
Dr. Alex Cahana
Distributed Systems Advisor
Expert at UN/CEFACT Economic Commission for Europe. Designed the verified distributed architecture behind Bloqcube's minimal-downtime data layer.
Distributed ledger technology expert at UN/CEFACT Economic Commission for Europe. One of the most credentialed practitioners globally at the intersection of verified data systems and healthcare. Shaped the architectural decisions behind Bloqcube's immutable audit layer and its regulatory defensibility under FDA and EMA scrutiny.