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PRECLINICAL DEVELOPMENT

Nonclinical Data Management

GLP-aligned data operations for nonclinical studies, connecting laboratory systems, traceable data workflows, and submission-ready outputs across toxicology and preclinical programs.

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Our Approach

Nonclinical Data Integrity Is a Regulatory Requirement, Not an After thought

GLP-regulated nonclinical programs generate complex data across toxicology, safety pharmacology, and DMPK from multiple systems, CROs, and study models. Spreadsheet-based workflows and disconnected laboratory environments increase integrity risk, audit exposure, and downstream delays. At IQA, we provide a unified nonclinical data management model aligned to GLP expectations and ALCOA+ principles, ensuring data remains attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available from the point of capture onward.

We manage study-level data flows, cross-CRO harmonization, ALCOA+ verification, and submission-ready packaging across laboratory systems, LIMS environments, and legacy source formats. Our team supports the full nonclinical data lifecycle, from raw laboratory capture through structured datasets, SEND-ready outputs, and regulatory submission support for IND, NDA, and broader lifecycle commitments.

Regulatory Foundation

GLP Requirements

Data integrity, traceability, and raw data retention for nonclinical safety studies

OECD GLP Principles

International principles supporting recorded, verifiable, and reviewable nonclinical data

Electronic Records Compliance

Controlled handling of computerized records, audit trails, and electronic documentation

ALCOA+ Principles

Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available

SEND Readiness

Structured nonclinical datasets prepared for standards-based regulatory submission

eCTD Packaging Support

Nonclinical outputs organized for global regulatory submission workflows

CORE CAPABILITIES

End-to-End Nonclinical Data Management

From GLP-aligned data capture and harmonization to SEND-ready datasets and submission support

GLP-Compliant Data Capture & Processing

Controlled data workflows from raw capture to traceable study datasets.
  • GLP-aligned data handling
  • ALCOA+ verification and audit trails
  • Structured study data processing

Preclinical Data System Expertise

Operational support across laboratory systems, LIMS environments, and legacy sources.
  • Configuration and data extraction support
  • Cross-system input review and mapping
  • Study-level workflow alignment

Cross-Study Data Harmonization

Normalization of data across laboratories, CROs, species, and study designs.
  • Multi-source data harmonization
  • Controlled terminology alignment
  • Portfolio-level consistency

Data Quality Assurance & Control

Quality checks designed to detect issues early and strengthen regulatory readiness.
  • Rule-based QC and verification
  • Outlier and discrepancy detection
  • Audit-ready data review support

Regulatory-Ready Data Packages

Structured outputs built for nonclinical submission workflows and global review.
  • Analysis-ready data packages
  • eCTD Module 4 support
  • Submission-ready documentation

Toxicology & Pharmacology Data Management

Specialized handling of toxicology, safety pharmacology, and pathology-related study data.
  • Toxicology and pathology data support
  • Safety pharmacology data workflows
  • Study-specific domain management

SEND & CDISC Dataset Preparation

Preparation of structured nonclinical datasets for standards-based regulatory submission.
  • SEND mapping and dataset preparation
  • Controlled terminology support
  • Define-ready submission assets

Bioanalysis & DMPK Data Integration

Integrated handling of bioanalytical, TK, and DMPK data for downstream analysis and reporting.
  • Bioanalytical data integration
  • TK and DMPK data alignment
  • Cross-study analytical readiness
DATA LIFECYCLE

From Raw Laboratory Data to Submission-Ready Datasets

Six controlled stages. GLP-aligned. ALCOA+ throughout.

1

Capture

Laboratory and LIMS data captured with traceability from source.

2

Clean

Validation, discrepancy review, and terminology alignment.

3

Harmonise

Cross-study, cross-lab, and cross-species data standardization.

4

Verify

QC, ALCOA+ checks, and audit-ready review.

5

Analyse

Data prepared for analysis, SEND, and downstream use.

6

Archive

Secure archival and retrieval-ready submission support.

WHY INDUCTIVE QUOTIENT

Nonclinical Data Expertise Built for Regulatory Submission

We manage nonclinical data with the end submission in mind - GLP integrity, SEND readiness, Module 4 packaging, and audit preparedness built in from Day 1.

GLP-First Approach
We manage nonclinical data within a regulatory framework, embedding GLP expectations, ALCOA+ principles, audit trail governance, and inspection readiness from study start.
Deep Operational System Expertise
We work hands-on across major nonclinical study and laboratory environments, supporting configuration, validation, data extraction, and operational workflows for sponsors and CROs.
Cross-CRO Harmonization
We normalize data across vendors, laboratories, species, and geographies to support cross-study analysis, portfolio consistency, and downstream regulatory readiness.
SEND-Ready Data Design
We structure nonclinical data with SEND conversion in mind from the start, reducing rework, improving terminology consistency, and accelerating submission preparation.
Submission-Integrated Delivery
Our data management model connects raw study data, SEND preparation, and regulatory packaging into one coordinated workflow.

Standards and Compliance

GLP Framework
GLP requirements for nonclinical study data
OECD GLP principles
Regional GLP expectations for global filings
Data Integrity
Electronic records and audit trail controls
ALCOA+ principles throughout
Computerized system governance
Submission Standards
SEND and nonclinical submission readiness
eCTD Module 4 support
Reviewer-ready regulatory packaging
System Validation
CSV / validation documentation
Risk-based validation approach
Access control and traceability standards
Get Started

Secure Your Nonclinical Data Before Your Next Regulatory Filing.

GLP-compliant, ALCOA+-verified and eCTD-ready - from raw laboratory capture through Module 4 packaging and SEND conversion.

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