Regulatory Compliance Excellence

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Regulatory Compliance

Regulatory Compliance

At Lambda Therapeutic Research, Regulatory Compliance is not just a requirement; it’s a commitment to ensuring the highest standards of quality, safety, and integrity in clinical research. We understand that navigating the complex landscape of global regulations is crucial to the success of your studies. That’s why we’re dedicated to staying at the forefront of compliance, protecting patient data, and delivering reliable results.

Our Approach

Constant Monitoring

We maintain a comprehensive regulatory intelligence database to stay informed about industry compliance issues. Our team of study start-up professionals and regulatory strategists share these insights with clients, ensuring access to robust data within evolving global compliance rules.

Innovative Digital Solutions

At Lambda, we've embraced digitalization to enhance research efficiency and streamline clinical data management processes. Since 2011, we've been leveraging advanced tools like Electronic Data Capture (EDC) technology (BizNET ®) to maintain clinical study data with the highest accuracy and quality. EDC allows real-time data capture, ensuring reliability and precision in results.

Comprehensive Software Suite

Our suite of software solutions, including IMPTrack®, KnowledgeNET®, and Biolyte®, enhances data retrievability and facilitates easy access to essential study documents. These tools are essential for maintaining data integrity, accuracy, and adherence to regulatory guidelines, ensuring reliable research outcomes.

Quality Management System

QEdge, Lambda's Enterprise Quality Management Software (eQMS), consolidates and enhances quality processes, making organizational processes more compliant and efficient. It optimizes processes such as Change Control, Deviation Management, CAPA, and more.

Efficiency and Compliance

By eliminating manual processes and paperwork, digitization reduces the risk of errors, ensuring accurate and consistent data capture. Electronic data capture systems streamline data collection and management, enhancing efficiency and compliance.

Data Integrity and Security

Digitization enhances data quality and solves data integrity challenges by implementing security measures such as user access controls, audit trails, and encryption. This ensures the integrity and confidentiality of research data, promoting trustworthiness in clinical research activities.

Regulatory Compliance Standards

Lambda's software strictly adheres to the guidelines set forth in 21 CFR Part 11 and EU Annex 11, providing a robust and secure platform for data management and regulatory compliance.

Secure Data Archival

At the end of a clinical study, all generated data are securely archived in a NAS (Network-Attached Storage) solution and the cloud, ensuring easy and convenient retrieval of electronic information while maintaining data integrity.

Proven Regulatory Track Record

Lambda has successfully undergone a significant number of international inspections and audits, including over 100 international inspections/audits, more than 250 sponsor audits, and above 1000 monitoring visits. We’ve achieved regulatory inspection success for the clinical studies conducted using regulatory-compliant electronic software, showcasing our commitment to maintaining rigorous quality standards and ensuring reliable research data.