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INTRODUCTION OF US
Non-Clinical Testing and Submission Services for ICH E14, S7B, and S7A Compliance
At INDCRO we offer end-to-end non-clinical testing, reporting, and consulting services tailored to ICH E14, S7B, and S7A guidelines.
Our expertise—spanning manual and automated patch-clamp testing of hERG, Late/Peak NaV1.5, and CaV1.2 channels, in vitro ECG, White Paper Framework for C-QTc, FDA submission consulting, MEA assessments, meta-analysis and pre-IND meeting support—empowers you to streamline development, optimize safety evaluations, and achieve regulatory success with fully prepared non-clinical study reports.
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OUR SERVICES
Our Services
Non-Clinical Evaluation of QT/QTc Prolongation
- hERG Assay
- NaV, CaV, Ligand-Gated Ion Channel Testing
- In Vivo QT Assays
- ECG and MEA-Based Assays
- Supplemental Studies
- More…
High throughput technology consulting and Data Analysis
- Automated Patch Clamp (SyncroPatch 384 and Qube) Data Analysis
- High-Throughput High-Content imaging
- Advanced Data Analytics: Meta-analysis, bioinformatics, machine learning and AI
Support for Clinical QT/QTc Evaluation
- Concentration-QTc Modeling
- Determination of critical concentrations and safety margins, validated by positive controls
Neurophysiology Study
- Brain slice patch clamp
- In vivo multi-channel recording methods and electrode fabrication
- Behavioral Assessment: Integrating Artificial Intelligence and Machine Learning
- More…
FDA Submission Consulting and Pre-IND Support
- Strategic guidance alignment with FDA standards, ICH E14/S7B Q&A, and White Paper Framework.
- GLP-compliant, CTD-formatted reports (Module 4)
- Pre-IND Meeting Preparation
Bioinformatics Analysis
- Whole Genome
- Epigenomics
- RNA-Seq
- Transcriptome
- Metagenomics
- Proteomics
- Pathway/Differential Expression
- More…
WHY CHOOSE US
FDA Expertise & Cutting-Edge Solutions for Your Success
FDA Experience: Our team includes experts who have worked at the FDA for many years, giving us deep insight into regulatory expectations and the review process.
Proven Expertise: Decades of experience in manual/automated patch-clamp testing, meta-analysis, C-QTc modeling, FDA consulting, and pre-IND support.
Regulatory Leadership: Authors of numerous regulatory science papers, with expertise in ICH guidelines, CiPA standards, and the White Paper Framework.
Advanced Technology: Cutting-edge manual/automated patch-clamp systems, EEG telemetry, MEA platforms, and analytical tools.
End-to-End Support: From testing to analytics to pre-IND preparation, we guide you every step.
Timely Results: Flexible approaches ensure high-quality data delivered on schedule.
OUR FEATURES
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