TEST-CDISC SEND Tools: Automate Your FDA IND Submission for Nonclinical Data

For biostatisticians, Contract Research Organizations (CROs), and animal model testing facilities, CDISC SEND tools are no longer optional — they are a regulatory necessity. The FDA mandates that all nonclinical study data submitted as part of an Investigational New Drug (IND) or New Drug Application (NDA) must comply with the CDISC SEND (Standard for Exchange of Nonclinical Data) format. Yet for many research organizations, manually formatting SEND datasets remains a time-consuming, error-prone process that delays submissions and increases compliance risk.

CLINS CDISC-SEND Converter by Ravis Technology changes that. Purpose-built for GLP-compliant test facilities, CROs, and biobanks across Southeast Asia and the Asia-Pacific region, CLINS automates the transformation of raw preclinical study data into CDISC-SEND compliant datasets — reducing regulatory submission costs by up to 30% and eliminating the need for manual reformatting.

The Regulatory Necessity of CDISC SEND

What Is CDISC SEND and Why Does It Matter?

CDISC SEND (Standard for Exchange of Nonclinical Data) is the FDA-mandated data standard for submitting nonclinical animal study data in IND and NDA applications. Since December 2016, SEND compliance has been mandatory for toxicology studies submitted to the FDA. Non-compliant submissions are one of the leading causes of FDA information requests (IRs) — adding weeks or months to review timelines.

As a CDISC Gold Member — the only Thai company to hold this distinction — Ravis Technology brings certified expertise in SEND implementation to every project. Our CLINS platform supports SENDIG v3.1.1 and is fully compliant with OECD-GLP standards, ensuring your datasets are submission-ready for both FDA and EMA regulatory pathways.

Who Needs CDISC SEND Tools?

CLINS CDISC-SEND Converter is designed for organizations across the nonclinical research value chain:

Biostatisticians — who need to map, validate, and convert nonclinical study data into SEND-compliant datasets without manual reformatting
Contract Research Organizations (CROs) such as Charles River and Freyr — managing regulatory submissions on behalf of sponsors and requiring fast, validated SEND outputs
Animal Model Testing Facilities and Biobanks including OECD-GLP animal model centers and NHP research facilities — generating study data that must meet FDA submission standards

What CLINS CDISC-SEND Converter Does

– Automated SEND Dataset Generation

Upload raw preclinical study data — in PDF or structured formats — and CLINS automatically transforms it into CDISC-SEND compliant datasets (SENDIG v3.1.1). JSON generation and automated QC validation are built in, eliminating manual reformatting entirely. The result: submission-ready datasets in a fraction of the time.

– Cloud-Based Submission Readiness

CLINS operates as a cloud-based platform, meaning no software installation or IT infrastructure investment is required. Study teams can access the system from anywhere, with role-based access controls and full audit trail logging — meeting 21 CFR Part 11 and OECD-GLP data integrity requirements.

– Bioresource and Inventory Integration

Beyond SEND formatting, CLINS includes integrated Bioresource and Inventory Control — centralized management of cell banks, biospecimens, chemicals, and consumables to maintain stock levels and quality. This end-to-end capability makes CLINS the most comprehensive preclinical data platform available in Southeast Asia.

– Lab Equipment Lifecycle Management

CLINS also supports automated scheduling and logs for instrument calibration and maintenance under ISO/IEC 17025 — ensuring your laboratory instruments are always inspection-ready and your data integrity is never compromised by equipment failures.

Proven Recognition and Industry Validation

CLINS CDISC-SEND Converter has earned recognition at the highest levels of the global life science industry:

Selected for presentation at PharmaSUG 2026, Boston, USA — the premier conference for pharmaceutical SAS programmers and data scientists
Winner, Startup Category at the ASOCIO Digital Summit 2025, Taipei — recognizing Asia-Pacific technology innovation
Winner, Thailand ICT Award 2024, Startup of the Year
CDISC Gold Member 2024–2025 — the only Thai company to hold this distinction
ISO/IEC 29110 certified by SGS — validated software development process quality

Pricing and Deployment

CLINS CDISC-SEND Converter is available on a per-study basis, making it accessible for organizations of all sizes — from single-study academic labs to high-throughput CROs managing multiple sponsor submissions simultaneously.

• CDISC-SEND Converter: starting at $2,999 per study

• Bioresource & Inventory Control: starting at $19,999 per site

• Lab Equipment Lifecycle Management: starting at $12,999 per site

All modules are available as part of the full CLINS Preclinical Suite — an end-to-end system for GLP-compliant test facilities and biobanks that integrates In Vivo Management, Study E-Data Management, Next-Gen LIMS, and regulatory submission tools in a single platform.

Ready to Automate Your FDA SEND Submission?

Whether you are a CRO managing multi-sponsor IND submissions, a GLP test facility looking to reduce manual data processing, or a biobank seeking compliant specimen and data management — CLINS is built for you. Contact Ravis Technology to request a demo or learn more about how CLINS can support your next FDA or EMA submission.

www.ravistechnology.com | info.ravistechnology@gmail.com