Quality Policy

Sofpromed is a full-service Contract Research Organization (CRO) specialized in the comprehensive management of phase I-IV clinical trials worldwide for the pharmaceutical, biotechnology, and academic research sectors across all therapeutic areas.

As we are aware that our business, reputation and success depend crucially on listening and fulfilling our client’s needs, we are firmly committed to providing them with efficient, high-quality services that always meet or exceed their demands and expectations. When sponsors entrust their clinical studies to Sofpromed, they can rest assured that our start-up, regulatory, monitoring, data management, and pharmacovigilance services will be delivered with the highest level of confidentiality, quality, and trust.

Sofpromed acknowledges the critical importance of Good Clinical Practice (GCP) and the need to guarantee patient rights and safety, as well as the completeness, reliability, traceability, and integrity of data collected during clinical trials. The company considers these aspects as a primary responsibility governing its operations and has adopted appropriate quality standards to ensure clinical trial success and customer satisfaction.

Not only do our professional clinical operations, biometrics, and upper management teams have an in-depth understanding of existing national and international legislation concerning clinical research, but they also have a wealth of experience in assisting sponsors and managing clinical studies of any phase, size, and complexity. As a result of this great expertise and devotion to clinical excellence, we can offer our clients the best quality of service. At Sofpromed, we are dedicated to continuous improvement and compliance with applicable regulations. Clear Quality Objectives, in accordance with the framework laid down within ISO 9001:2015, provide a fundamental basis for all our processes and activities.

Sofpromed’s top management and the organization at every level, are fully committed to the development and implementation of the quality management system and the steady improvement in its operating effectiveness.

Patricio Ledesma Figueroa

CEO

Sofpromed Investigación Clínica S.L.