Connected · Configurable · Clinically Informed

One Connected eClinical Platform for Faster Trial Execution

Run EDC, RTSM, CTMS/eTMF, ePRO and eConsent through a configurable cloud platform built for sponsors and CROs — with study builds in days, not months.

Pharma Sponsors
CROs
Sites
Connected · Configurable · Clinically Informed
Sponsors
CROs
Sites
Patients
Connected Platform Architecture
100% Parameter-Driven
Days Study Build Time
Hours RTSM Go-Live
40% Less IP Waste
3 Continents Served
 21 CFR Part 11 Ready

The Problem We Solve

Fragmented trial systems are costing you time, data quality, and competitive advantage

Most clinical teams juggle 4–6 disconnected point solutions. The result: duplicate data entry, manual reconciliation, and months lost before first patient first visit.

Months to First Patient

Legacy EDC and RTSM vendors take 8–24 weeks to build a study. Every week of delay costs clinical budget and competitive advantage.

Data Silos & Reconciliation

When EDC, RTSM, and CTMS are separate systems, data never stays in sync. Teams waste weeks on reconciliation that should be instant.

Enterprise Cost, SME Budget

Medidata and Veeva were built for large pharma. Small and mid-size sponsors and CROs end up overpaying for capabilities they cannot fully use.

Unified eClinical Suite

End-to-end platform connecting every stakeholder and system in your clinical trial ecosystem

Site Intelligence

AI Driven Site Feasibility & Selection

Transform site selection with AI-powered scoring, achieving up to 90% predictive accuracy and reducing site failure rates dramatically.

AI-Powered Site Scoring
Predictive models analyze historical performance, enrollment, dropout, and logistics
One-Click Feasibility
Digital questionnaires with 95% response rates in under a week
DEI Metrics & Risk Insights
Predictive enrollment risk with diversity metrics aligned to protocol targets
Geo-Logistics Optimization
Smart site selection considering geographic distribution and accessibility

Site Selection Dashboard

AI Powered

Geographic Site Distribution

Interactive Map View

Memorial Research Center
High enrollment rate • Strong DEI
Score: 94
City Clinical Institute
Good logistics • Proven track
Score: 87
Regional Health Network
Diverse population • Rapid startup
Score: 82
156
Sites Evaluated
95%
Response Rate
5 days
Avg. Completion
AI Authoring

AI Protocol & CSR Authoring

Cut protocol and CSR writing time by 60–70% with AI-driven drafting, guided workflows, and automated compliance checks.

Human-Reviewed AI Drafting
Generate first drafts for protocols and CSRs using templates and historical content
Guided Workflows
Orchestrate review tasks, approvals, and audit trails automatically
Compliance Checks
Automated validation for ICH, FDA, and EMA guidelines with version control
Templates & Analytics
Pre-built templates with time-saved dashboards and standardization metrics

Protocol Editor

AI Assist — Human Review Required
Section
1.0 Synopsis
Status
✓ Draft Complete

1.1 Study Objectives: The primary objective is to evaluate the efficacy and safety of…

1.2 Study Design: This is a Phase III, multicenter, randomized, double-blind…

1.3 Study Population: Approximately 450 adult patients with confirmed diagnosis…

AI Suggestion
Consider adding DEI enrollment targets and decentralized visit options per FDA 2023 guidance.
2.0 Study Objectives
3.0 Study Endpoints
4.0 Safety Assessments

Solutions for End-to-End Clinical Operations

Specialized services that complement our eClinical products, helping sponsors and CROs manage data, projects, and compliance across the full trial lifecycle

Clinical Data Management

CDM services ensure accuracy, completeness, and consistency of clinical trial data while meeting regulatory requirements

Design and build CRFs/EDC databases leveraging SOLASTA@edc for efficient data capture

Manage data validation, discrepancy handling, and medical coding to maintain clean datasets

Oversee database lock and data extraction processes supporting statistical analysis

Project Management

Shilowiz project managers coordinate cross-functional clinical teams to deliver studies on time, within scope, and to quality expectations

End-to-end planning, timelines, and resource allocation for clinical activities

Risk and issue tracking with proactive mitigation and stakeholder communication

Progress tracking using dashboards integrated with Shilowiz platforms

Consulting Services

Shilowiz provides QA, validation, and regulatory consulting to help clients design compliant processes and systems

QA and validation support for eClinical systems, including document review

Process and SOP consulting to align trial operations with GCP expectations

Audit readiness and remediation guidance for inspection-ready documentation

Looking for a tailored combination of technology and services?

Who We Serve

Built for the Teams Running Clinical Trials

Different buyers have different priorities. Select your role to see how Shilowiz addresses your specific challenges.

Pharma & Biotech

Your challenges as a sponsor

  • Protocol amendments derail timelines and require expensive re-validation cycles with your current vendor
  • Your EDC, RTSM, and CTMS don't talk to each other — reconciliation is manual and error-prone
  • Enterprise vendor pricing wasn't built for your company size — you're paying for capability you can't use
  • Regulatory submissions require extensive manual documentation that slows down your quality team

How Shilowiz helps: One unified platform means your EDC, RTSM, and CTMS share a single data model. Protocol amendments apply in hours with controlled change records. Regulatory documentation — audit trails, e-signatures, RBAC controls — is built in, not a consultant add-on.

Days
Study build vs 8–24 week legacy average
Hours
Protocol amendment turnaround
Single
Login across EDC, RTSM, CTMS, eTMF, ePRO
30–40%
Lower total cost of ownership

Compliance controls included:

Audit trailE-signaturesRBAC 21 CFR Part 11ICH E6 R3GDPR Validation docsChange control
Contract Research Organisations

Your challenges as a CRO

  • Every sponsor wants a different EDC or RTSM — your team ends up managing 5 different platforms
  • Study builds take weeks — you're losing bids to vendors who promise faster startup
  • Site activation is bottlenecked by slow feasibility and fragmented site management processes
  • Sponsor qualification questionnaires require documentation your current vendors don't provide easily

How Shilowiz helps: One platform your team learns once — configurable per sponsor, per study. NAVON@site accelerates feasibility with 95% response rates in under a week. Vendor qualification documentation is packaged and ready for sponsor review.

95%
Feasibility response rate in under a week
Days
From protocol to study build go-live
One
Platform for all sponsors — configurable per study
Ready
Vendor qualification documentation on request

Products most used by CROs:

SOLASTA@edc COPIOUS@rtsm NAVON@site ALLEGIANT@ctms
Research Sites & Investigators

Your challenges as a site

  • Your coordinators log into a different system for every study — training overhead is significant
  • Data entry screens are complex and generate excessive queries that take hours to resolve
  • Patient randomisation requires calling an IRT hotline or navigating a complex separate system
  • eTMF submissions are manual, time-consuming, and always seem to be flagged at inspection

How Shilowiz helps: One login gives site coordinators access to EDC, randomisation, and eTMF. AI-driven query reduction means 80% fewer queries to resolve. COPIOUS@rtsm integrates directly into the EDC workflow — no separate IRT login.

80%
Fewer data queries vs legacy EDC
One
Login for EDC, RTSM, eTMF, ePRO
Instant
Randomisation integrated with EDC workflow
98%
eTMF inspection-readiness rate

Site training time:

Most site coordinators are proficient in SOLASTA@edc within a single half-day onboarding session. The interface is designed for clinical staff, not IT professionals.

Why Shilowiz vs Fragmented Systems

Move beyond disconnected point solutions to a unified eClinical OS that accelerates trials and reduces costs

Single Source of Truth

Eliminate data silos with unified data architecture across EDC, RTSM, CTMS, and AI tools. Real-time synchronization ensures consistency.

No double data entry

Instant cross-system updates

Unified reporting dashboard

Dynamic Configuration

Parameter-driven design enables zero-code changes and rapid mid-study amendments without validation cycles or downtime.

Changes in hours, not weeks

Controlled changes preserve change history and validation documentation

Full audit trail maintained

Enterprise Integration

API-first architecture with Documented API connectors for labs, safety, CTMS, EDC, RTSM, analytics, and identity systems and SSO. Integrate with existing enterprise systems seamlessly.

RESTful APIs & webhooks

Single sign-on enabled

Cloud-native & scalable

Proven Impact Metrics
Real results from unified eClinical systems
Weeks, not Months
Go-Live Time
Rapid deployment with pre-configured templates and automated setup
60–70% Faster
Authoring Speed
AI-powered protocol and CSR writing cuts development time significantly
30–40% Lower
Total Cost
Reduced TCO through automation, integration, and operational efficiency
Faster Study Startup
Accelerate from protocol to first patient with integrated feasibility and site activation
Reduced Site Failure
AI-powered site selection identifies high-performing sites with up to 90% accuracy
Higher Data Quality
Real-time validation, AI query automation, and unified data architecture ensure clean data
Regulatory Ready
Designed to support regulated workflows with audit trails, e-signatures, RBAC, version control, and validation documentation — aligned to 21 CFR Part 11, Annex 11, ICH-GCP, and GDPR requirements

Contact Us

Reach out with questions about our eClinical products, services, or partnerships. Our team will respond promptly to discuss how Shilowiz can support your clinical trial needs.

We'll reply to you soon

Book a Meeting Now

Schedule time directly with the Shilowiz team for personalized demos or in-depth discussions about your clinical trial requirements.

Schedule a Demo

Choose a convenient slot to speak with our experts about your study needs

Other Ways to Connect

Support Hours
Mon-Fri, 9AM-6PM EST

One Integrated eClinical Suite for Modern Trials

Unify data from protocol design through site selection, randomization, execution, and reporting with the Shilowiz eClinical OS

SOLASTA@edc

EDC (Electronic Data Capture) — faster builds, cleaner data, built-in ePRO

  • Go live in 2 weeks
  • 80% fewer queries with AI
  • Built-in ePRO & eConsent
Learn more
COPIOUS@rtsm

RTSM (Randomisation & Trial Supply) — go live in hours, 40% less IP waste

  • Live in hours, not weeks
  • 40% reduction in IP waste
  • DCT ready with geo-tracking
Learn more
NEW
ALLEGIANT@ctms

CTMS built for CROs — executive oversight, risk-based monitoring, site visits, and payments natively connected to EDC & RTSM

  • One-week onboarding, per-study pricing
  • Native sync with SOLASTA & COPIOUS
  • Built-in AI assistant & GST invoicing
View product
NAVON@site

Site Intelligence — AI-powered feasibility scoring with 90% predictive accuracy

  • 90% predictive accuracy
  • 95% response in under a week
  • DEI metrics & risk insights
View product
BINAH@ai

Clinical AI Authoring — human-reviewed AI drafting for protocols and CSRs

  • 60-70% faster authoring
  • ICH E6 R3, 21 CFR Part 11, and Annex 11 controls
  • Role-based workflow
View product
 Integration Layer
ISHLOV@Integration

Real-time, bidirectional synchronisation engine that keeps EDC, RTSM, and CTMS aligned — with native SSO and zero reconciliation debt

  • Free within the full Shilowiz stack
  • Live in ~1 week, parameter-driven
  • Native SSO across EDC, RTSM, CTMS
View product
Managed Services

SaaS, managed services, and hybrid deployment models tailored to your needs

  • Flexible deployment options
  • 24/7 support & monitoring
  • Dedicated success team
Learn more
Study Oversight
ALLEGIANT@ctms

Enterprise CTMS at Per-Study Pricing — For CROs of Any Size

ALLEGIANT@CTMS delivers executive-grade portfolio oversight, risk-based monitoring, site visit management, GST-compliant payments, and eTMF compliance — natively connected to SOLASTA@EDC and COPIOUS@RTSM.

True SSO across CTMS, EDC, RTSM, ePRO, and eTMF with unified user management

API-first SaaS architecture with Documented API connectors for labs, safety, CTMS, EDC, RTSM, analytics, and identity systems to existing systems

Dynamic real-time reconciliation with SOLASTA@edc and COPIOUS@rtsm

Instant mid-study changes with unified dashboards and faster milestone delivery

Watch ALLEGIANT@ctms Overview
Product demo video
847
Active Sites
98.2%
eTMF Ready
15ms
Sync Time
Intelligent EDC & eSource
SOLASTA@edc

Faster Builds, Cleaner Data

Rapid configuration, AI-assisted cleaning, built-in ePRO/eConsent, and risk-based monitoring in one powerful EDC platform

SOLASTA@EDC screenshot 1
1 / 6
Data Entry — Subject Grid
Real-time status tracking across all enrolled subjects with colour-coded CRF completion indicators
Go Live in 2 Weeks

Rapid study build with pre-configured templates and automated CRF generation. First patient first visit in record time.

Reduced faster FPFV
Zero Code Amendments

Mid-study changes implemented in hours with parameter-driven configuration. Controlled mid-study changes reduce rebuild effort while preserving change control, audit history, and validation documentation.

Amendments in hours
AI Query Automation

Reduce manual queries by 80% with intelligent data validation, auto-resolution, and machine learning-powered cleaning.

Rapid DB lock
Built-In Patient Experience

Integrated ePRO, eConsent, and patient-facing mobile apps. No third-party integrations needed – everything works together seamlessly.

Mobile-first ePRO & eDiary

Interactive eConsent workflows

Multi-language support

Real-Time Risk-Based Monitoring

AI-powered risk indicators, automated SDV triggers, and centralized monitoring dashboards that prioritize site visits and interventions.

Predictive risk scoring

Automated KRI dashboards

Targeted SDV workflows

Connected by Design

SOLASTA@edc seamlessly integrates with COPIOUS@rtsm and ALLEGIANT@ctms – kit reconciliation to CRF in real-time with zero manual work

SOLASTA@edc
COPIOUS@rtsm
ALLEGIANT@ctms
COPIOUS@rtsm

Smarter Randomization, Confident Supply

Cloud-native RTSM with adaptive randomization engines and predictive supply management that eliminates waste and accelerates patient enrollment.

COPIOUS@RTSM screenshot 1
1 / 7
Subjects Task Dashboard
Real-time task view showing Randomization (2), Dispensing (13), and Completion (1) pending actions across all enrolled subjects
Cloud Native Setup

Go live in hours with cloud-native deployment and instant scaling

Hours to live
Smart Randomization

Adaptive algorithms with real-time stratification and balancing

Instant allocation
Predictive Supply

AI forecasting reduces investigational product waste by 40%

40% less waste
DCT Ready

Direct-to-patient shipping with geo-tracking and temperature monitoring

Full logistics
Optimized Logistics & DCT Ready

Built for decentralized trials with geo-tracking, temperature monitoring, depot management, and direct-to-patient shipping workflows. 99.9% uptime SLA.

Real-time depot inventory

Temperature excursion alerts

Automated resupply triggers

Seamless EDC & Suite Integration

Kit assignment flows directly to SOLASTA@edc CRFs. Visit windows, dosing schedules, and compliance tracking synchronized in real-time across the entire suite.

Traditional IRT vs COPIOUS@rtsm

Legacy systems take weeks to configure and struggle with mid-study changes. COPIOUS@rtsm delivers instant deployment and zero-downtime updates.

Hours
vs weeks setup time
40%
waste reduction

End-to-End Clinical Trial Value

From protocol design to regulatory submission, Shilowiz covers every stage

Plan & Design
BINAH@ai for protocol authoring
60-70% faster
Select Sites
NAVON@site AI scoring
90% accuracy
Randomize
COPIOUS@rtsm supply
40% less waste
Execute
SOLASTA@edc + ALLEGIANT@ctms
Real-time sync
Analyze & Report
BINAH@ai CSR authoring
Reg ready

See Shilowiz With Your Protocol — Book a 30-Minute Demo

Schedule a personalized demo to see how Shilowiz can accelerate your drug development program

 Intelligent EDC & eSource SOLASTA@edc

Faster Builds. Cleaner Data. Built-in Patient Engagement.

SOLASTA@EDC is a cloud-native, 100% parameter-driven electronic data capture platform. Go live in two weeks, apply protocol amendments in hours, and resolve 80% fewer queries — with ePRO, eConsent, and risk-based monitoring built in.

2 Wks
Go-Live Time
80%
Fewer Queries
50%
Faster FPFV
SOLASTA@EDC screenshot
1 / 6

Key Capabilities

Everything your study team needs — no third-party integrations

2-Week Go-Live

Parameter-driven study build from pre-configured templates. CRFs, edit checks, visit schedules, and roles configured in days — not months of development sprints.

AI Query Automation

Machine-learning query detection, auto-resolution, and intelligent data validation reduce manual query workload by up to 80% — accelerating database lock.

Zero-Code Amendments

Protocol amendments applied in hours with controlled change records, impact assessment, and preserved audit history. No re-validation cycles, no downtime.

Built-in ePRO & eConsent

Mobile-first ePRO and eDiary with multilingual support. Interactive eConsent workflows. No third-party integrations needed — all in one platform.

Risk-Based Monitoring

AI-powered KRI dashboards, predictive risk scoring, and targeted SDV workflows. Focus monitoring resources on the sites and subjects that need attention most.

21 CFR Part 11 by Design

Audit trails, e-signatures, RBAC, and validation documentation are native — not add-ons. Full support for ICH E6 R3, GDPR, and Annex 11.

Connected to the full Shilowiz suite

SOLASTA@EDC shares a unified data model with COPIOUS@RTSM and ALLEGIANT@CTMS through ISHLOV — enrollment status, kit dispensation, and visit compliance sync automatically.

COPIOUS@rtsm

Go live in 2 weeks with SOLASTA@EDC

Book a 30-minute walkthrough scoped to your protocol — see your study structure, not a generic demo.

 Intelligent RTSM & Supply Management COPIOUS@rtsm

Go Live in Hours. Waste 40% Less IP. Never Miss a Resupply.

COPIOUS@RTSM is a cloud-native randomisation and trial supply management platform that deploys in hours — not weeks. Adaptive randomisation engines and AI-powered supply forecasting eliminate IP waste and keep patients on treatment.

Hours
Go-Live Time
40%
Less IP Waste
99.9%
Uptime SLA
COPIOUS@RTSM screenshot
1 / 7

Key Capabilities

End-to-end randomisation and supply in one system

Hours to Go-Live

Cloud-native deployment with parameter-driven configuration. A new RTSM study can be configured and go live within hours — no lengthy IRT build or UAT sprint.

Adaptive Randomisation

Real-time stratified randomisation with dynamic balancing across sites and strata. Supports parallel, sequential, adaptive, and re-randomisation designs.

Predictive Supply Forecasting

AI-powered supply models account for enrollment rate, visit compliance, dropout, and depot geography — reducing IP waste by 40% while eliminating stockouts.

DCT & Geo-Logistics

Direct-to-patient shipping with geo-tracking, temperature monitoring, and depot management. Supports decentralised, hybrid, and traditional trial designs.

Full IP Lifecycle

FIFO-based shipment automation, buffer-stock monitoring, automated resupply triggers, and depot-to-destruction accountability with complete audit trail.

Kit Replacement & Returns

Guided workflows for kit replacement (damaged, lost, quarantine), subject returns, drug accountability reporting, and batch kit status updates.

Traditional IRT vs COPIOUS@RTSM

Legacy IRT platforms take weeks to configure. COPIOUS@RTSM delivers instant deployment and zero-downtime parameter updates — at a price point that works for mid-size studies.

Hours
vs weeks setup time
40%
waste reduction

Natively connected to SOLASTA@EDC & ALLEGIANT@CTMS

Kit dispensation flows to EDC CRFs automatically. Enrollment and supply data appear in CTMS without manual export. ISHLOV keeps everything in sync in real time.

Go live in hours with COPIOUS@RTSM

Book a 30-minute walkthrough scoped to your randomisation design and supply chain requirements.

NAVON@site

AI Driven Site Feasibility & Selection

BINAH@ai generates first drafts, orchestrates review workflows, and checks regulatory compliance to cut protocol and CSR writing time by 60–70%.

90%
Predictive Accuracy
95%
Response Rate
5 days
Avg. Completion

Site Selection Dashboard

AI Powered

Geographic Site Distribution

Interactive Map View

Memorial Research Center
High enrollment • Strong DEI
94
City Clinical Institute
Good logistics • Proven track
87
Regional Health Network
Diverse population • Rapid startup
82

Designed for Site Selection Excellence

Purpose-built for clinical operations teams managing complex multi-site global studies

AI-Powered Site Scoring

Predictive models analyze historical performance, enrollment rates, dropout patterns, and logistics to generate accurate site scores

One-Click Feasibility

Digital questionnaires with 95% response rates in under a week. Automated scoring and comparison across hundreds of sites

DEI Metrics & Risk Insights

Predictive enrollment risk with diversity metrics aligned to protocol targets and FDA 2023 diversity guidance

Start selecting better sites today

See how NAVON@site can transform your site selection process

BINAH@ai

AI Driven Protocol & CSR Authoring

BINAH@ai generates first drafts, orchestrates review workflows, and checks regulatory compliance to cut protocol and CSR writing time by 60–70%.

60-70%
Faster Authoring
100%
Audit Trail
ICH/FDA
Compliant

Protocol Editor

AI Active
Section
1.0 Synopsis
Status
✓ Draft Ready

1.1 Study Objectives: The primary objective is to evaluate the efficacy and safety of investigational compound XYZ-123…

1.2 Study Design: This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study…

1.3 Study Population: Approximately 450 adult patients aged 18-75 with confirmed diagnosis…

AI Suggestion
Consider adding diversity enrollment targets per FDA 2023 guidance. Recommend 30% underrepresented minorities.
Last saved: 1 min agov2.3

Designed for Clinical Writing Teams

Purpose-built for medical writers, clinical operations, and regulatory affairs professionals

Medical Writers

Focus on clinical narrative and strategy while AI handles first drafts, formatting, and compliance checks

Clinical Operations

Track protocol development milestones, manage amendments, and collaborate with cross-functional teams

Regulatory Affairs

Automated compliance validation for ICH, FDA, and EMA guidelines with full audit trail for submissions

Transform your clinical writing process

See how BINAH@ai can cut your authoring time by 60-70%

 NEW · Now onboarding pilot studies
ALLEGIANT@ctms

Clinical Trial Management, Finally Built for CROs, Not Just Big Pharma

One console for study oversight, risk-based monitoring, site visits, payments, and compliance — natively connected to SOLASTA@EDC, SOLASTA@ePRO, and COPIOUS@RTSM through ISHLOV, so your data moves once and shows up everywhere.

✓Per-study pricing
✓One-week onboarding
✓CDSCO-aligned, Azure India
✓21 CFR Part 11 by design
Executive Dashboard
Portfolio Overview
LIVE
847
Enrolled Subjects
+12 this week
94%
TMF Completeness
↑ 3% vs last month
2
High-Risk Sites
Action items open
98.2%
Payment Timeliness
3 milestones pending
SiteEnrollmentRiskTMF
AIIMS Delhi48/60Low97%
Kokilaben Mumbai31/50Medium84%
Apollo Chennai22/40High71%
Live sync from SOLASTA@EDC · COPIOUS@RTSM · 3 sites shown of 12
 The Gap ALLEGIANT@CTMS Closes

Most CTMS platforms are priced and built for enterprise sponsors running dozens of concurrent global trials. Boutique CROs and small pharma sponsors are left stitching together spreadsheets for site visit tracking, milestone-based payments, and risk oversight — with no single view of study health. ALLEGIANT@CTMS closes that gap: enterprise-grade oversight delivered at per-study pricing that a five-study CRO can actually justify — and it’s the only CTMS that talks natively to your EDC, ePRO, and RTSM out of the box.

Why ALLEGIANT@CTMS

Six reasons CROs choose ALLEGIANT over generic CTMS platforms

Native Shilowiz integration
ALLEGIANT@CTMS connects to SOLASTA@EDC, SOLASTA@ePRO, and COPIOUS@RTSM through ISHLOV — enrollment, visit, query, and randomisation data sync automatically. No manual reconciliation between your EDC and your CTMS.
India-hosted, CDSCO-aligned
Deployed on Microsoft Azure with data residency and access controls aligned to Indian regulatory expectations — built for CROs operating under CDSCO oversight, not retrofitted from a US-first platform.
Per-study pricing
No enterprise-tier minimums. Pay for the studies you’re running, scale up as your portfolio grows. A five-study CRO pays like a five-study CRO.
One-week onboarding
Like every Shilowiz product, ALLEGIANT@CTMS is fully parameter-driven — a new study can be configured and live within approximately a week. No long professional services engagement to get started.
Built-in AI assistant
Ask questions in plain language and get answers as a quick list, a full data table, or a chart — rendered directly in the dashboard, not a separate export. “Which sites are behind on visit compliance?”
21 CFR Part 11-aware by design
Audit trails, e-signatures on trip reports and approvals, and role-based access controls are native to ALLEGIANT@CTMS — not compliance features added as an afterthought.

Key Capabilities

Everything your study team needs in one console

Eleven integrated modules that replace the spreadsheets, shared drives, and disconnected point tools most CROs rely on today.

Executive Oversight

Real-time portfolio view — TMF completeness, payment timeliness, risk alerts, enrollment, and drug supply across every active study on a single filterable dashboard with a geographic site-risk heatmap.

eTMF & Compliance

Track document status, filing timeliness, and TMF completeness against ICH E6(R2) real-time-TMF expectations, with expiry tracking and a guided document management portal.

Risk-Based Monitoring (KRI/KEI)

Configurable Key Risk Indicators and Key Efficacy Indicators surface the sites and subjects that need attention first — a living risk view tied to your monitoring plan, not a static report.

Site Visit & Trip Report Hub

Schedule SIVs, routine visits, co-monitoring, and close-outs in a guided workflow; log trip report findings, action items, and follow-ups — with action items linked directly into Risk Monitoring.

Remote SDV (rSDV)

Track source data verification progress and status across sites and subjects without requiring an on-site visit for every check. SDV status visible at subject and site level.

Enrollment & RTSM Sync

Live enrollment tracking synced from COPIOUS@RTSM — randomisation, arm assignment, and stratification visibility without leaving CTMS. Kit dispensation and resupply alerts included.

Clinical Payments

Track contracted milestones per site, generate GST-compliant invoices with multi-currency support directly from achieved milestones, and monitor payment timeliness portfolio-wide.

Safety & Unblinding Oversight

SAE reporting timeliness, safety signal visibility, and access-controlled unblinding and deviation tracking — all in one place, without switching systems.

Visit & Dosing Compliance

Visit adherence, missed/late visit tracking, and dosing compliance with one-click report generation scoped by study, site, or CRA — in PDF, Excel, or on-screen.

Drug Supply Visibility

Site-level inventory, dispensation tracking, and resupply alerts synced from your RTSM, so drug supply risk appears on the same dashboard as everything else.

System Integration Console

Connect ALLEGIANT@CTMS to native Shilowiz products, third-party EDC/eTMF/safety systems, or flat-file imports through a guided integration wizard with field-level mapping and sync health monitoring.

 Built-in AI Assistant

Ask ALLEGIANT anything

Plain-language questions. Answers in the format that fits — a quick list in the chat panel, or a full table or chart opened directly in your workspace. No exports, no waiting for a report to run.

“Which sites are behind on visit compliance this month?”

“Generate this quarter’s payment timeliness report.”

“Show me enrollment trend by site for the past 8 weeks.”

ALLEGIANT AI — LIVE ASSISTANT
You
Which sites have open monitoring action items older than 14 days?
AI
3 sites with overdue monitoring actions:
Apollo Chennai — 2 actions, oldest 22 days (CRA: S. Mehta)
Fortis Bangalore — 1 action, 18 days (CRA: R. Nair)
PGIMER Chandigarh — 1 action, 15 days (CRA: P. Singh)
Open in Risk Monitor → or export as PDF

Who It’s For

Built for the teams legacy CTMS vendors ignored

Indian CROs

Running multiple small-to-mid-size studies who need portfolio visibility without enterprise CTMS pricing — and CDSCO-aligned documentation without adapting a US-first platform.

CDSCO-alignedAzure IndiaGST invoicing

Small & Mid-size Sponsors

Pharma and nutraceutical sponsors managing outsourced trials who want real oversight into CRO performance — enrollment, visit compliance, payments — without building an in-house ops team.

Sponsor oversightCRO performancePer-study

Existing Shilowiz Teams

Already on SOLASTA@EDC/ePRO or COPIOUS@RTSM? Add ALLEGIANT@CTMS for study management without a second vendor, a second contract, or a second data silo to reconcile.

Zero reconciliationNative syncSingle login

Natively connected to the full Shilowiz suite

Enrollment, visit, query, and randomisation data sync automatically through ISHLOV — your data moves once and shows up everywhere.

ALLEGIANT@ctms
ALLEGIANT@CTMS
ISHLOV
SOLASTA@edc
COPIOUS@rtsm
Enrollment
Auto-synced from RTSM
Queries
Live from EDC
Supply
Kit status via RTSM
Visits
Compliance from EDC

See your entire trial portfolio in one place.

ALLEGIANT@CTMS is now onboarding pilot studies. Get a walkthrough scoped to your current study profile — no generic demo, just your data model.

 Data Fabric Layer
ISHLOV@Integration

The Data Fabric Behind Your eClinical Stack

Not a CTMS. Not a point-to-point patch. ISHLOV is the live, bidirectional synchronisation layer that keeps EDC, RTSM, and CTMS speaking the same truth — in real time, without manual reconciliation.

Every clinical trial runs on 3–6 disconnected systems. ISHLOV connects them so your teams stop re-entering, re-checking, and re-explaining the same data across platforms.

Live Sync Status
SOLASTA@EDC
Source active
↕ ISHLOV SYNC LAYER ↕
COPIOUS@RTSM
In sync
ALLEGIANT@CTMS
In sync
Recent sync events
✓ Subject 004-023 enrolled2s ago
✓ Kit KIT-2291 dispensed14s ago
✓ Visit 3 form completed1m ago
✓ Query #887 resolved4m ago
Zero manual reconciliation · 0 exceptions

How ISHLOV Works

One source of truth per domain. Automatic everywhere else.

ISHLOV is a parameter-driven integration engine purpose-built for eClinical data exchange. For every data domain in a study, it defines which system is the source of truth and which systems are recipients — then keeps them synchronised automatically as data changes.

Source System

Where the data lives

The system where a data point is originally captured and authoritative. ISHLOV treats this system as the single owner of that data domain for that study.

Recipient System(s)

Where it flows automatically

Systems that consume a synchronised, read-aligned copy of that data point. Recipients never require re-entry — they receive changes the moment the source updates.

Sync Mode

Real-time or scheduled

Real-time (event-triggered) or scheduled (interval-based), configurable per domain. Reconciliation is automated with conflict detection and full audit trail — not manual cross-checking.

Example 1

Subject Demographics

SOURCE
SOLASTA@EDC

Site coordinator enters subject demographics (DOB, sex, enrollment date) at the eCRF

RECIPIENT
COPIOUS@RTSM

Demographics auto-populate the randomisation record — no re-entry, no transcription error

RECIPIENT
ALLEGIANT@CTMS

Subject status and demographics reflect instantly in site/study tracking dashboards

Example 2

Kit / Drug Supply Information

SOURCE
COPIOUS@RTSM

Kit assignment, dispensation, and inventory status logged at randomisation/dispensation

RECIPIENT
ALLEGIANT@CTMS

Site-level drug accountability and supply forecasts update automatically

RECIPIENT
SOLASTA@EDC

Dispensed kit ID and dispensation date populate the eCRF — eliminating manual kit-number entry errors

“Every data domain has one owner and multiple consumers. ISHLOV enforces that discipline automatically — so ‘which system is correct?’ is never a question your team has to ask.”

Additional synchronised domains

Visit/schedule status → EDC → CTMS Randomisation arm → RTSM → EDC, CTMS Query status → EDC → CTMS Safety events → EDC → CTMS Enrollment status → RTSM → CTMS

Single Sign-On

One Login. Zero Reconciliation Debt. Zero Integration Cost.

ISHLOV includes native SSO across the Shilowiz eClinical suite — SOLASTA@EDC, COPIOUS@RTSM, and ALLEGIANT@CTMS. Because SSO is native to systems built on the same platform foundation, it works out of the box the moment you’re on Shilowiz.

 Without ISHLOV SSO / Integration

Site staff maintain 3 separate logins, 3 password policies
Data managers manually cross-check EDC vs RTSM vs CTMS weekly
Reconciliation is a scheduled labor line-item (typically 1 CRA/DM day per site per cycle)
Errors surface at monitoring visits or audits — late and costly
Access provisioning done per system, per user

 With ISHLOV SSO / Integration

One credential, one access point across the entire suite
Discrepancies flagged automatically at point of entry
Reconciliation effort reduces to exception review only
Errors surface at the point of divergence — same day
Provisioned once, applies across the stack instantly
20
Typical sites in a mid-size study
18
Month study duration (average)
5-fig
USD saved in reconciliation labor per study

Manual reconciliation across EDC, RTSM, and CTMS typically consumes several hours of CRA/data management time per site per monthly cycle. Across a 20-site study over 18 months, that’s a five-figure USD labor cost — before counting the downstream cost of query resolution when reconciliation catches errors late. ISHLOV collapses that labor into automated, real-time sync with exception-only human review.

Standardise on Shilowiz — integration is free

Clients running the full Shilowiz stack (EDC + RTSM + CTMS) get ISHLOV integration and SSO at no additional connector cost. Per-connector pricing only applies when bridging to third-party systems outside the Shilowiz suite.

Market Differentiators

This is not a CTMS. That’s the point.

Most vendors bundle “integration” as a feature buried inside a CTMS or EDC module — meaning you’re locked into their ecosystem. ISHLOV is architected as an independent integration layer.

Differentiator ISHLOV@Integration Typical Market Approach
ArchitectureStandalone, system-agnostic integration engineIntegration bundled inside a single vendor’s CTMS/EDC — works only within their suite
Deployment speedParameter-driven; connector goes live within ~1 weekCustom API/middleware builds — weeks to months per connection
Source-of-truth governanceExplicit, domain-level source/recipient mapping, configurable per studyAd hoc; often relies on manual export/import or point solutions
SSO scopeNative across EDC, RTSM, CTMS from day oneOften single-system SSO or a separate IAM procurement
Cost modelFree within the Shilowiz stack (EDC+RTSM+CTMS); per-connector pricing only when bridging to third-party systemsEnterprise platform licensing — pay for the whole suite to get sync, regardless of vendor mix
Fit for mid-size CROs/sponsorsPurpose-built — no enterprise-scale budget assumedDesigned for large pharma budgets; overkill and overpriced for mid-market trials

“ISHLOV works across any eClinical stack — but standardise on Shilowiz, and integration stops being a line item altogether. Your systems agree on the data, and your budget agrees with you.”

Ready to eliminate manual reconciliation?

See ISHLOV connect your eClinical stack

Book a walkthrough that maps ISHLOV to your current system landscape — EDC, RTSM, CTMS, or a mix of third-party and Shilowiz tools.

About Shilowiz

Shilowiz is a cloud-based eClinical technology company focused on making drug development faster, more accurate, productive, and easier to track for sponsors and CROs worldwide.

Who We Are

Shilowiz builds integrated, cloud-native platforms and applications designed by clinical researchers and informatics experts to improve how companies conduct clinical trials, share and control data, track patient outcomes, and manage regulatory information.

Speed up clinical trials

Increase transparency and data quality

Improve patient outcomes through smarter technology

At a Glance

Founded 2020

Headquartered in Hyderabad, India

Cloud-Native Platform

eClinical suite for global sponsors and CROs

Integrated Solutions

Focused on EDC, RTSM, CTMS, and AI-driven tools

Global Reach

Serving pharmaceutical companies and CROs worldwide

Vision

To become a global leader in cutting-edge technological innovation for drug development, empowering researchers and sponsors to bring life-changing treatments to patients faster and more efficiently.

Mission

Be a leading provider of innovative, integrated eClinical systems

Establish Shilowiz as a visible, reliable one-stop integration brand

Partner professionally with customers to deliver people-friendly solutions

Our Values

The principles that guide how we build products, serve customers, and work together

Transparency & Integrity

We value honesty and ethical behavior in every interaction. Our commitment to transparency ensures that our customers, partners, and team members can trust us to do what's right.

Focus & Ownership

We maintain clear focus on clinical trial outcomes and take ownership of our commitments. Every team member is empowered to drive results and deliver excellence.

Innovation & Collaboration

We embrace innovation and cultivate diverse, collaborative teams. By partnering closely with our customers, we create breakthrough solutions that advance clinical research.

Partner with Us to Accelerate Your Clinical Trials

Join leading pharmaceutical companies and CROs who trust Shilowiz to power their clinical research

 Trust Center

Security, Compliance & Validation

Everything procurement teams, QA leads, and IT directors need to evaluate Shilowiz — from regulatory controls and validation approach to security architecture and data governance.

Regulatory Controls

Specific Controls, Not Broad Claims

We list the actual technical and procedural controls built into the platform — not marketing language.

Electronic Signatures
21 CFR Part 11 compliant e-signatures on all record-creating, amending, and approving actions. Full signature manifest captured per record.
Part 11 §11.50
Audit Trail
Immutable, time-stamped audit trail for all data creation, modification, and deletion. Captures user identity, action, timestamp, and previous value. Cannot be modified or deleted.
Part 11 §11.10(e)
Role-Based Access Control
Granular RBAC with configurable roles per study, site, and module. Separation of duties enforced. Access review logs available.
Part 11 §11.10(d)
System Validation
Platform validated per GAMP 5 category 4/5 guidelines. IQ/OQ/PQ documentation available. Study-level validation support provided on request.
ICH Q10 / GAMP 5
Change Control
All platform changes follow a documented change control process with impact assessment, testing, and release notes. Protocol amendments create versioned change records within the study.
ICH E6 R3
Data Integrity (ALCOA+)
All data entries are Attributable, Legible, Contemporaneous, Original, and Accurate. Backup, Enduring, Available, Complete, Consistent controls implemented throughout.
ALCOA+
Annex 11 (EU GMP)
System design aligned to EU GMP Annex 11 requirements for computerised systems including validation, data storage, and electronic signatures.
Annex 11
Privacy (GDPR / HIPAA)
Pseudonymisation of subject data. Regional data residency options available. Data Processing Agreement (DPA) available on request. Subject rights workflows supported.
GDPR · HIPAA

Security Architecture

Enterprise Security, Transparent Controls

Shilowiz is built on Microsoft Azure with security controls appropriate for regulated clinical data environments.

Encryption

Data encrypted in transit (TLS 1.2+) and at rest (AES-256). Database-level and field-level encryption for sensitive subject data.

Identity & Access

SSO via SAML 2.0 and OpenID Connect. MFA enforced. Session timeout controls. Privileged access management with break-glass logging.

Availability & DR

99.9% uptime SLA. Geo-redundant Azure deployment. Automated daily backups with point-in-time recovery. RTO and RPO documented in Business Continuity Plan.

Data Residency

Primary hosting on Microsoft Azure India. Regional data residency options available for EU, US, and other jurisdictions on request. Data does not leave the contracted region.

Penetration Testing

Annual third-party penetration testing. Vulnerability management programme with tracked remediation timelines. Findings summary available to qualified customers under NDA.

Subprocessors

Subprocessor list maintained and published. Material changes notified with 30-day advance notice. Microsoft Azure is the primary infrastructure subprocessor.

AI Governance

AI in Regulated Clinical Workflows

Our AI governance principles are designed for regulated environments where every decision must be traceable, reversible, and human-approved.

Human-in-the-Loop Required

Every AI suggestion — whether a query resolution, a site score, a supply forecast, or a protocol section — requires explicit human review and approval before it takes effect. AI outputs are suggestions, not decisions.

Full Audit Trail of AI Actions

All AI-generated suggestions and human decisions are captured in the audit trail with user identity, timestamp, and outcome. AI actions are distinguishable from human actions in all records.

Customer Data Boundaries

Customer study data is never used to train or fine-tune AI models without explicit written consent. Data used for AI inference remains within your contracted data residency region.

Model Versioning & Traceability

AI model versions are tracked and documented. Output traceability allows reconstruction of which model version produced which suggestion at any point in time.

AI Governance Summary

Every AI suggestion requires human approval
AI actions are separate & auditable vs human actions
No training on customer data without consent
AI outputs include source citations where applicable
Model versions tracked and documented for traceability

What Happens After You Sign

From Contract to First Patient: Our Go-Live Process

A structured, collaborative implementation process with defined milestones — so you always know where you are.

1

Discovery & Configuration

Protocol review, study parameter mapping, role setup. Typically 2–5 days for standard studies.

2

Build & Integration

Parameter-driven study build, external connector configuration, UAT environment preparation.

3

Validation & UAT

IQ/OQ execution, UAT scripts, validation documentation package, site training materials.

4

Go-Live & Support

Production launch, hypercare support period, dedicated study manager through first data lock.

Typical go-live timeline

Simple study (Phase II, <20 eCRFs): 5–10 days  |  Complex study (Phase III, adaptive): 2–4 weeks

Compared to 8–24 weeks for legacy EDC vendors

Integration Directory

Named Connectors by Category

Documented REST APIs and named connectors — not a claim, a list. Full API documentation available on request.

Clinical Data Systems

Medidata Rave (API)Oracle InFormREDCap Castor EDCViedocOpenClinica CDISC ODM/XML

Safety & Pharmacovigilance

Oracle ArgusVeeva Vault Safety ARISgE2B(R3) export MedDRA codingWHO-DD coding

Laboratory Systems

HL7 FHIR R4LabVantage LIMS Labcore Central LabICON Lab Lab result XML import

Identity & SSO

Microsoft Entra IDOkta Auth0SAML 2.0 OpenID ConnectActive Directory

Analytics & Reporting

Power BITableau SAS (SDTM export)R export CDISC SDTM v3.4ADaM datasets

Document & eTMF

Veeva Vault eTMFWingspan eTMF SharePointTMF Reference Model DIA RBM Ref Model

Need a specific connector not listed? Our API-first architecture supports custom integrations.

Ready to complete your vendor evaluation?

Request our Vendor Qualification Pack — security overview, compliance controls matrix, validation overview, and architecture diagram