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.
The Problem We Solve
Most clinical teams juggle 4–6 disconnected point solutions. The result: duplicate data entry, manual reconciliation, and months lost before first patient first visit.
Legacy EDC and RTSM vendors take 8–24 weeks to build a study. Every week of delay costs clinical budget and competitive advantage.
When EDC, RTSM, and CTMS are separate systems, data never stays in sync. Teams waste weeks on reconciliation that should be instant.
Medidata and Veeva were built for large pharma. Small and mid-size sponsors and CROs end up overpaying for capabilities they cannot fully use.
End-to-end platform connecting every stakeholder and system in your clinical trial ecosystem
Transform site selection with AI-powered scoring, achieving up to 90% predictive accuracy and reducing site failure rates dramatically.
Geographic Site Distribution
Interactive Map View
Cut protocol and CSR writing time by 60–70% with AI-driven drafting, guided workflows, and automated compliance checks.
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…
Specialized services that complement our eClinical products, helping sponsors and CROs manage data, projects, and compliance across the full trial lifecycle
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
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
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
Different buyers have different priorities. Select your role to see how Shilowiz addresses your specific challenges.
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.
Compliance controls included:
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.
Products most used by CROs:
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.
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.
Move beyond disconnected point solutions to a unified eClinical OS that accelerates trials and reduces costs
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
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
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
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.
Schedule time directly with the Shilowiz team for personalized demos or in-depth discussions about your clinical trial requirements.
Schedule a DemoChoose a convenient slot to speak with our experts about your study needs
Unify data from protocol design through site selection, randomization, execution, and reporting with the Shilowiz eClinical OS
EDC (Electronic Data Capture) — faster builds, cleaner data, built-in ePRO
RTSM (Randomisation & Trial Supply) — go live in hours, 40% less IP waste
CTMS built for CROs — executive oversight, risk-based monitoring, site visits, and payments natively connected to EDC & RTSM
Site Intelligence — AI-powered feasibility scoring with 90% predictive accuracy
Clinical AI Authoring — human-reviewed AI drafting for protocols and CSRs
Real-time, bidirectional synchronisation engine that keeps EDC, RTSM, and CTMS aligned — with native SSO and zero reconciliation debt
SaaS, managed services, and hybrid deployment models tailored to your needs
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
Rapid configuration, AI-assisted cleaning, built-in ePRO/eConsent, and risk-based monitoring in one powerful EDC platform
Rapid study build with pre-configured templates and automated CRF generation. First patient first visit in record time.
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.
Reduce manual queries by 80% with intelligent data validation, auto-resolution, and machine learning-powered cleaning.
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
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
SOLASTA@edc seamlessly integrates with COPIOUS@rtsm and ALLEGIANT@ctms – kit reconciliation to CRF in real-time with zero manual work
Cloud-native RTSM with adaptive randomization engines and predictive supply management that eliminates waste and accelerates patient enrollment.
Go live in hours with cloud-native deployment and instant scaling
Adaptive algorithms with real-time stratification and balancing
AI forecasting reduces investigational product waste by 40%
Direct-to-patient shipping with geo-tracking and temperature monitoring
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
Kit assignment flows directly to SOLASTA@edc CRFs. Visit windows, dosing schedules, and compliance tracking synchronized in real-time across the entire suite.
Legacy systems take weeks to configure and struggle with mid-study changes. COPIOUS@rtsm delivers instant deployment and zero-downtime updates.
From protocol design to regulatory submission, Shilowiz covers every stage
Schedule a personalized demo to see how Shilowiz can accelerate your drug development program
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.
Key Capabilities
Parameter-driven study build from pre-configured templates. CRFs, edit checks, visit schedules, and roles configured in days — not months of development sprints.
Machine-learning query detection, auto-resolution, and intelligent data validation reduce manual query workload by up to 80% — accelerating database lock.
Protocol amendments applied in hours with controlled change records, impact assessment, and preserved audit history. No re-validation cycles, no downtime.
Mobile-first ePRO and eDiary with multilingual support. Interactive eConsent workflows. No third-party integrations needed — all in one platform.
AI-powered KRI dashboards, predictive risk scoring, and targeted SDV workflows. Focus monitoring resources on the sites and subjects that need attention most.
Audit trails, e-signatures, RBAC, and validation documentation are native — not add-ons. Full support for ICH E6 R3, GDPR, and Annex 11.
SOLASTA@EDC shares a unified data model with COPIOUS@RTSM and ALLEGIANT@CTMS through ISHLOV — enrollment status, kit dispensation, and visit compliance sync automatically.
Book a 30-minute walkthrough scoped to your protocol — see your study structure, not a generic demo.
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.
Key Capabilities
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.
Real-time stratified randomisation with dynamic balancing across sites and strata. Supports parallel, sequential, adaptive, and re-randomisation designs.
AI-powered supply models account for enrollment rate, visit compliance, dropout, and depot geography — reducing IP waste by 40% while eliminating stockouts.
Direct-to-patient shipping with geo-tracking, temperature monitoring, and depot management. Supports decentralised, hybrid, and traditional trial designs.
FIFO-based shipment automation, buffer-stock monitoring, automated resupply triggers, and depot-to-destruction accountability with complete audit trail.
Guided workflows for kit replacement (damaged, lost, quarantine), subject returns, drug accountability reporting, and batch kit status updates.
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.
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.
Book a 30-minute walkthrough scoped to your randomisation design and supply chain requirements.
BINAH@ai generates first drafts, orchestrates review workflows, and checks regulatory compliance to cut protocol and CSR writing time by 60–70%.
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…
Purpose-built for medical writers, clinical operations, and regulatory affairs professionals
Focus on clinical narrative and strategy while AI handles first drafts, formatting, and compliance checks
Track protocol development milestones, manage amendments, and collaborate with cross-functional teams
Automated compliance validation for ICH, FDA, and EMA guidelines with full audit trail for submissions
See how BINAH@ai can cut your authoring time by 60-70%
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.
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
Key Capabilities
Eleven integrated modules that replace the spreadsheets, shared drives, and disconnected point tools most CROs rely on today.
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.
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.
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.
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.
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.
Live enrollment tracking synced from COPIOUS@RTSM — randomisation, arm assignment, and stratification visibility without leaving CTMS. Kit dispensation and resupply alerts included.
Track contracted milestones per site, generate GST-compliant invoices with multi-currency support directly from achieved milestones, and monitor payment timeliness portfolio-wide.
SAE reporting timeliness, safety signal visibility, and access-controlled unblinding and deviation tracking — all in one place, without switching systems.
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.
Site-level inventory, dispensation tracking, and resupply alerts synced from your RTSM, so drug supply risk appears on the same dashboard as everything else.
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.
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.”
Who It’s For
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.
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.
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.
Enrollment, visit, query, and randomisation data sync automatically through ISHLOV — your data moves once and shows up everywhere.
ALLEGIANT@CTMS is now onboarding pilot studies. Get a walkthrough scoped to your current study profile — no generic demo, just your data model.
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.
How ISHLOV Works
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.
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.
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.
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.
Site coordinator enters subject demographics (DOB, sex, enrollment date) at the eCRF
Demographics auto-populate the randomisation record — no re-entry, no transcription error
Subject status and demographics reflect instantly in site/study tracking dashboards
Kit assignment, dispensation, and inventory status logged at randomisation/dispensation
Site-level drug accountability and supply forecasts update automatically
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.”
Single Sign-On
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.
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.
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
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 |
|---|---|---|
| Architecture | Standalone, system-agnostic integration engine | Integration bundled inside a single vendor’s CTMS/EDC — works only within their suite |
| Deployment speed | Parameter-driven; connector goes live within ~1 week | Custom API/middleware builds — weeks to months per connection |
| Source-of-truth governance | Explicit, domain-level source/recipient mapping, configurable per study | Ad hoc; often relies on manual export/import or point solutions |
| SSO scope | Native across EDC, RTSM, CTMS from day one | Often single-system SSO or a separate IAM procurement |
| Cost model | Free within the Shilowiz stack (EDC+RTSM+CTMS); per-connector pricing only when bridging to third-party systems | Enterprise platform licensing — pay for the whole suite to get sync, regardless of vendor mix |
| Fit for mid-size CROs/sponsors | Purpose-built — no enterprise-scale budget assumed | Designed 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?
Book a walkthrough that maps ISHLOV to your current system landscape — EDC, RTSM, CTMS, or a mix of third-party and Shilowiz tools.
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.
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
Headquartered in Hyderabad, India
eClinical suite for global sponsors and CROs
Focused on EDC, RTSM, CTMS, and AI-driven tools
Serving pharmaceutical companies and CROs worldwide
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.
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
The principles that guide how we build products, serve customers, and work together
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.
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.
We embrace innovation and cultivate diverse, collaborative teams. By partnering closely with our customers, we create breakthrough solutions that advance clinical research.
Join leading pharmaceutical companies and CROs who trust Shilowiz to power their clinical research
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
We list the actual technical and procedural controls built into the platform — not marketing language.
Security Architecture
Shilowiz is built on Microsoft Azure with security controls appropriate for regulated clinical data environments.
Data encrypted in transit (TLS 1.2+) and at rest (AES-256). Database-level and field-level encryption for sensitive subject data.
SSO via SAML 2.0 and OpenID Connect. MFA enforced. Session timeout controls. Privileged access management with break-glass logging.
99.9% uptime SLA. Geo-redundant Azure deployment. Automated daily backups with point-in-time recovery. RTO and RPO documented in Business Continuity Plan.
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.
Annual third-party penetration testing. Vulnerability management programme with tracked remediation timelines. Findings summary available to qualified customers under NDA.
Subprocessor list maintained and published. Material changes notified with 30-day advance notice. Microsoft Azure is the primary infrastructure subprocessor.
AI Governance
Our AI governance principles are designed for regulated environments where every decision must be traceable, reversible, and human-approved.
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.
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 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.
AI model versions are tracked and documented. Output traceability allows reconstruction of which model version produced which suggestion at any point in time.
What Happens After You Sign
A structured, collaborative implementation process with defined milestones — so you always know where you are.
Protocol review, study parameter mapping, role setup. Typically 2–5 days for standard studies.
Parameter-driven study build, external connector configuration, UAT environment preparation.
IQ/OQ execution, UAT scripts, validation documentation package, site training materials.
Production launch, hypercare support period, dedicated study manager through first data lock.
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
Documented REST APIs and named connectors — not a claim, a list. Full API documentation available on request.
Need a specific connector not listed? Our API-first architecture supports custom integrations.
Request our Vendor Qualification Pack — security overview, compliance controls matrix, validation overview, and architecture diagram