Evidence + Strategy

Quality + 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.

Designed for Trust

Our quality program enables sponsors to adopt digital measures with confidence —knowing that patient safety, privacy, and scientific rigor are protected at every step.

Let’s Work Together

Whether you’re designing your first digital study or scaling a global program, Koneksa brings the science, platform, and people to deliver.