Inductive logo
PRECLINICAL DEVELOPMENT

CDISC SEND Services

SEND conversion, validation, and submission-ready support for nonclinical toxicology and preclinical study data.

Talk to Us
patternpattern
CDISC SEND Services
Our Approach

From Raw Nonclinical Data to Submission-Ready SEND

Inductive Quotient converts raw nonclinical study data from platforms such as Provantis, Pristima, Watson LIMS, spreadsheets, and legacy sources into structured, SEND-compliant datasets built for regulatory submission. We support the full SEND lifecycle from source assessment and domain mapping through controlled terminology, validation, Define-XML, and reviewer-ready submission assets.

Our team works across SEND implementation guide classes, including Findings, Events, Interventions, and Trial Design, with a delivery model built for traceability, consistency, and quality control. For multi-CRO and multi-lab programs, we help standardize data across systems, species, and study designs so sponsors can assemble a cleaner, more submission-ready nonclinical portfolio.

Regulatory Readiness

FDA SEND scope by study type
Genetic toxicology scope clarified in current FDA guidance
PMDA electronic study data submission and validation rules
Validation-first delivery with reviewer-ready documentation
Standardized portfolio support across laboratories and programs
Core Capabilities

End-to-End SEND Expertise

SEND Dataset Creation
Mapping to standard and custom domains - DM, BW, CL, FW, LB, MA, MI, OM, PC, PP, TF and more.
Source Data Review
Harmonizing fragmented data from multi-CRO or legacy systems into a single, clean source.
Pinnacle 21 Validation
Rigorous error remediation with annotated reports - zero critical or high-priority findings.
Define.xml & nSDRG
Authoring critical metadata and reviewer guides for FDA and PMDA submissions.
Automated Pipelines
Configurable connectors for Provantis and Pristima with batch processing support.
Legacy Conversion
Rescuing fragmented Excel, PDF, or LIMS data for compliant archiving and submission.
FDA Submission Support
eCTD Module 4 assembly and Technical Conformance Guide (TCG) adherence.
Program-Level Standardization
Portfolio-wide consistency for sponsors with multiple CROs and study types.
Our Process

From Raw Data to Submission

01
Assess
Mapping gap analysis and controlled terminology review.
02
Map
Domain conversion to SEND-compliant XPT datasets.
03
Validate
Pinnacle 21 Enterprise validation and 3-tier QC.
04
Document
Generation of Define.xml v2.1 and the nSDRG.
05
Submit
Final packaging and health authority query support.

Let Us Prepare Your SEND Submission

Get your SEND package right the first time - source data assessment to submission-ready datasets.

Request a SEND Assessment