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Quality Policy

Sofpromed is a full service contract research organization (CRO) specialized in the integral management of phase I-IV clinical trials with drugs in oncology for the pharmaceutical, biotechnology, and academic research sectors.

When sponsors entrust their clinical studies to Sofpromed, they can be confident that our start-up, regulatory, monitoring, data management, and pharmacovigilance services will be provided in accordance with the highest quality management principles and international standards.

Sofpromed recognizes the critical importance of Good Clinical Practice (GCP) and the need to guarantee patient rights and safety, as well as the reliability of data in clinical trials. The company views these aspects as a primary responsibility that governs its clinical operations, and has adopted appropriate quality standards to ensure study success and customer satisfaction.

Our team has a deep knowledge of clinical trial legislation and wide experience in cancer studies, to deliver the highest quality of service. We have implemented a quality and process management system aligned with the ISO 9001:2015 standard, able to guarantee:

  • compliance with applicable regulations,
  • the client’s expectations and requirements regarding the services provided, and
  • the continuous improvement of our activities.

In this line, we have established the following quality objectives in our organization:

  • comply with all applicable legislations and standards
  • train our staff in the needs and responsibilities of quality management
  • ensure that our services meet the highest standards of quality and cost effectiveness
  • follow a concept of continuous improvement and make best use of our management resources in all quality matters
  • communicate our quality objectives and performance throughout the company and to interested parties

Sofpromed’s upper management, and the organization at every level, is fully committed to service excellence, customer satisfaction, and the progress of healthcare for the good of society.