EDC Software for Clinical Trials in India
CDSCO and CTRI-aligned EDC for India’s booming clinical research market
India’s cost advantage is real, but international sponsors will only work with sites that produce inspection-grade data. Elysium gives you compliant eCRF capture with rupee-transparent pricing.
- Compliant audit trails & e-signatures
- Local-currency pricing: ₹86 to USD
- 14-day free trial, no credit card
- Deploy in days, not months
India has become one of the most important clinical trial markets globally, offering deep site networks, a massive patient pool and operational costs that make multi-site studies financially viable. The Drugs Controller General of India (DCGI) and the Central Drugs Standard Control Organisation (CDSCO) regulate trials under the New Drugs and Clinical Trials Rules, 2019, and registration through the Indian Council of Medical Research’s Clinical Trials Registry of India (CTRI) is mandatory for any trial conducted in the country.
The concern international sponsors raise is always data integrity. India’s best sites are globally competitive, but the gap between good and average sites is often the system they use for data. Elysium Clinical Trials EDC closes that gap: a modern, cloud-based eCRF platform with the audit trail, query workflow and electronic-signature capability that sponsors need when they visit or audit an Indian site.
This page sets out how Elysium maps to Indian clinical trial regulations and what the platform costs in Indian rupees.
Local Regulatory Authorities & Data Integrity
Elysium is engineered for the record-keeping expectations of the authorities that govern clinical research in India.
CDSCO / DCGI (New Drugs & CT Rules, 2019)
CDSCO grants approval for clinical trials of new drugs in India. Elysium supports the data-integrity and documentation standards underpinning those approvals, including audit trails and records.
ICMR National Ethical Guidelines & CTRI
The Indian Council of Medical Research sets the ethical framework; CTRI registration is mandatory for any Indian trial. System-level data governance supports the transparency expectations behind CTRI requirements.
Digital Personal Data Protection Act 2023 (DPDP)
India’s new data protection law aligns closely with GDPR: purpose limitation, consent, breach notification and processor obligations. Elysium supports these requirements through RBAC, encryption and access logs.
ICH GCP E6(R2)
The ICH GCP standard is widely expected by international sponsors working with Indian sites. Elysium’s workflows match the query, SDV and data-quality processes CROs and sponsors require.
Indian CROs and site networks frequently participate in global trials alongside US, EU and Japanese sites. Elysium is deliberately compatible with the data environments those sponsors use — the same exports, the same audit-trail granularity and the same CDISC formats — so an Indian site does not need a different system from the other regions in the trial.
A Complete Electronic Data Capture Platform
Everything your study team needs, from first CRF draft to database lock and export.
Drag-free eCRF Builder
Design case report forms with validation, skip logic and required-field rules — no code.
Study & Subject Management
Manage sites, visits, subjects and ePRO/pROM instruments from one workspace.
Security & Access Control
Role-based permissions, two-factor-ready logins, encryption in transit and at rest.
Queries & SDV
Raise, answer and close queries; schedule source-data-verification tasks for monitors.
Audit Trail
Every edit, signature and query is attributed, time-stamped and non-destructive.
Export & Reporting
Export to CSV, Excel, JSON or CDISC ODM; API access for downstream pipelines.
Electronic Signatures
e-sign at form, visit or study level with full linkage to the signer and timestamp.
Randomization
Coding and allocation management with support for commonly used randomization schemes.
Medical Coding
MedDRA/WHO-Drug-style term coding within the same environment you enter data.
From Sign-Up to First Data in Three Steps
Create an Account
Sign up for a 14-day free trial. No credit card, no procurement delay — your team can explore immediately.
Build Your CRFs
Model your study, sites and visits, then assemble eCRFs with the visual builder — most studies are live within a day.
Enroll & Monitor
Invite site staff, enroll subjects, run queries and SDV, then lock and export when your database is clean.
Built for how research teams in India actually work
- Infrastructure designed for high-enrolment, high-volume Indian studies
- Affordable, per-user pricing that scales to multi-site hospital networks
- Multi-site management so a sponsor or CRO can oversee 50+ Indian sites
- English and Hindi forms where local language support is needed
- Audit trails and e-signatures that meet CDSCO and international GCP standards
- API and export connections for real-world data integration
India’s sites compete globally for trial participation, and those that invest in better data infrastructure win more work. Elysium levels the playing field for sites and CROs, giving them a modern platform that sponsors trust at a per-subject cost compatible with the Indian market.
Pricing for India in Indian Rupee
Transparent, local-currency figures so you can budget without doing the forex math. Billing on your invoice is in US dollars; equivalents are shown at the current rate.
Starter
For small studies and independent researchers
- 5 Studyies
- 50 Subjects
- 5 Users
- 2GB Storage
- Core EDC
- CSV Export and Import
- Audit Trail & Reports
- Internal Messaging System
- Query Management
Professional
For growing research teams and CROs
- 15 Studyies
- 500 Subjects
- 15 Users
- 5GB Storage
- REST API Access
- Core EDC
- CSV / Excel Export
- Audit Trail and Reports
- Internal Messaging System
- Query Management
Enterprise
For organizations running multiple concurrent studies
- 100 Studyies
- 5,000 Subjects
- 100 Users
- 25GB Storage
- REST API Access
- Core EDC
- All Exports / Import Options
- Audit Trail and Reports
- Query Management
- Priority Support
- Internal Messaging System
- Medical Coding (ATC/DDD, WHO ICD-10, LOINC)
- REST Api Access
- Desktop app (works offline as well)
Unlimited Plan
For large CROs and enterprise sponsors
- Unlimited Studyies
- Unlimited Subjects
- Unlimited Users
- 100GB Storage
- REST API Access
- All Advanced Features
- Dedicated Support
- Custom SLA
- Complete System Training
- Internal Messaging System
- Medical Coding (ATC/DDD, WHO ICD-10, LOINC)
- *Sensitive Medical Coding (medDRA and WHODrugs)
- REST API Access
- Desktop app (works offline as well)
Need a dedicated EDC built for your organization?
Custom study types, self-hosted or private-cloud deployment, local regulatory and language support, dedicated SLAs, SSO, and audit packs for India-based sponsors and CROs.
Questions about EDC for India
Does Elysium support CDSCO and DCGI requirements?
Elysium provides the data-capture and record-keeping foundation that CDSCO and DCGI expectations depend on: audit trails on every change, electronic signatures and versioned records. Trial approval itself is issued by CDSCO; Elysium supports the data quality those approvals require.
Can I use Elysium for a high-volume Indian study?
Yes. Studies with hundreds of sites and thousands of subjects use Elysium without issue. The platform is cloud-based and the data model scales by design rather than by bolt-on.
Does it support Hindi?
Form labels and content are fully customisable text, so you can write them in English, Hindi, or both within the same study. Many sponsors run English eCRFs for global consistency and add Hindi instructions for site staff.
What about DPDP Act and data protection?
Elysium processes data under your instructions with access controlled by role and permission. Data is encrypted and every action is audited. Your organisation determines data location and retention; we recommend you confirm your positioning with your compliance team.
How are Indian rupee prices shown?
This page shows INR-equivalent figures at the current exchange rate to help local teams budget. Subscriptions are invoiced in US dollars on your selected plan; see the pricing section for current rupee numbers.
Elysium EDC in other regions
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