— Clinical Trials —
Quality and Compliance
Our approach integrates a robust, independent Quality Management System (QMS) with global regulatory expectations and industry best practices.
We are committed to enabling high-quality clinical research through secure, validated, and compliant systems that ensure patient safety, data integrity, and sponsor confidence.
GxP Framework and Regulatory Alignment
Our systems and processes are built on internationally recognized GxP standards and regulatory guidance, including:
ICH E6 Good Clinical Practice (GCP)
21 CFR Part 11: Electronic Records and Electronic Signatures
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
General Data Protection Regulation (GDPR)
Data Privacy Framework (DPF) Requirements
We take a proactive and structured approach to regulatory alignment across all our software and services supporting clinical trials.
Independent, ISO-Based Quality System
Koneksa maintains an established and independently managed QMS, grounded in ISO 9000 principles, ensuring a culture of continuous improvement and quality accountability across the organization.
Data Integrity (DI) controls aligned with ALCOA+ principles
Good Documentation Practices (GDP)
Validated systems supporting GCP-regulated use
Regular internal audits, SOP governance, and CAPA processes
Security and Data Protection by Design
We embed security and privacy into every layer of our platform through industry standard Technical and Organizational Measures (TOMs). Our approach includes:
Secure, access-controlled data environments
Encryption of data at rest and in transit
Role-based access and audit trails
Vendor and device qualification procedures
Our team supports sponsors with Data Protection Impact Assessments (DPIAs) and other documentation required by global regulators and IRBs.Our team supports sponsors with Data Protection Impact Assessments (DPIAs) and other documentation required by global regulators and IRBs.
Sponsor & IRB Support
We partner with clinical sponsors to streamline compliance with Institutional Review Boards (IRBs) and informed consent processes:
Assistance with ICF language describing digital measures and remote monitoring
Detailed documentation on data flows and retention
Support for device and vendor qualification
