IND Package Preparation
Successful IND submissions rely on comprehensive and regulatory-compliant preclinical data, CMC information, and clinical protocol documentation. IND readiness, including SEND documents, is where earlier data quality decisions are rewarded or alternatively cause costly reworks. SEND requires not only correct structure, but consistency and internal traceability1. Instem provides two solutions for regulatory submissions, Submit™ and SEND Advantage™ Services. These solutions help ensure regulatory-compliant IND packages can be submitted with confidence.
High-Quality SEND Submissions with Submit™
Submit is a solution that simplifies the creation and management of SEND datasets, supporting regulatory-compliant IND package preparations. The platform features nine modules designed to support SEND readiness, which an organization can activate as needed. These include SENDirect™, which automates SEND dataset generation, DefineNow™, which rapidly produces compliant files, and Send Checker, which comprehensively reviews datasets to ensure SEND compliance. Through modules like these, Submit not only supports compliance but also boosts efficiency with automated workflows, improves dataset consistency and accuracy, saves time, and reduces submission costs.
SEND Advantage™ Services: Simplifying SEND Processes
IND package preparation can be time-consuming, and SEND-compliant datasets are complex to produce. The SEND Advantage Services use an expert team that supports the creation of SEND data format submissions, ensures that nonclinical data meets the SEND submission standards, provides quality verification, and delivers robust compliance checks. SEND Advantage™ Services can convert nonclinical study data into the SEND format and apply verification and conformance checks. Organizations can also access bespoke consultancy and training services to help optimize SEND processes. These features ensure that data complies with SEND requirements, allowing IND submissions to proceed with confidence.
Quality and Compliance at Every Step
Quality and compliance are crucial at every stage of drug discovery and development, from target identification to IND package preparation. Even when the science is robust, inconsistent documentation and uncontrolled files can introduce compliance risks. That’s why Instem provides study management and laboratory execution solutions that negate common regulatory challenges and support high-quality workflows in drug discovery from end-to-end.
For managing modern laboratories, Matrix Gemini™ is a comprehensive LIMS platform for information management, from data collection to reporting, while adhering to global compliance and quality standards, including FDA 21 CFR Part 11 and ISO17025. The solution can be flexibly implemented across diverse systems and all market sectors, enabling researchers in drug discovery to have a system that adapts to their workflows as the development process evolves.
For quality management, eQCM™ supports workflows such as CAPA, audits, change management, and document management, which occur at each stage of drug discovery. Crucially, the platform maintains alignment with standards such as ISO, GxP, 21 CFR Part 11, IACUC, and AAALAC. By reducing informational silos and aligning with regulatory requirements, the software promotes fidelity, data integrity, and, importantly, compliance with global regulations.
Finally, for real-time compliance monitoring, Compliance Builder™ works across all major file types to strengthen data integrity and compliance in file-based systems. All data events are securely recorded with audit trails and electronic signatures, ensuring 21 CFR Part 11 compliance. Computer-generated audit trails reduce the need for inefficient, error-prone manual work, streamlining the drug discovery process by reducing time spent on audit-readiness.
Together, Instem’s solutions empower organizations to advance drug discovery with confidence, knowing quality and compliance are built into every step.
Conclusion: Enhance Drug Discovery with Instem
Instem provides a suite of connected solutions that unify data, workflows, and compliance across the drug discovery lifecycle, following the journey of a molecule from target identification to IND submission. Rather than addressing individual bottlenecks in isolation, Instem enables organizations to build an end-to-end digital environment where quality, traceability, and regulatory readiness are holistically addressed. By reducing fragmentation and strengthening data integrity, researchers can focus on accelerating scientific discovery and advancing promising molecules through the drug development process with greater speed and confidence.
Contact one of our experts to discover how Instem’s connected platforms can help accelerate your end-to-end drug discovery journey, from target identification through to IND submission.
- Choudhary S, Walker A, Funk K, Keenan C, Khan I, Maratea K. The Standard for the Exchange of Nonclinical Data (SEND): Challenges and Promises. Toxicol Pathol. 2018;46(8):1006-1012. doi:10.1177/0192623318805743 ↩︎
