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Sponsors

Inspired by patient-centric innovation & technology

Our clinical trials deliver maximum quality and efficiency, the best practices and rigorous compliance with global regulatory agencies, ensuring total data integrity, transparency and safety for patients

WHY US?

  • We offer a wide range of integrated services for research and development
  • Access to a large and qualified patient base, including rare and orphan diseases
  • Access to a wide range of specialties
  • Access to a research site network to guarantee clinical trial feasibility
  • Infrastructure capable of supporting clinical trials phase I, II, III and IV
  • Close collaboration with public health institutions
  • Quality assurance compliant to the most rigorous standards and the most important regulatory agencies

OUR SERVICES

  • Centralized project contracting
  • Site selection within SMO network
  • Site administrative processes
  • Site preparation
  • Investigator preparation
  • Quality Management on the site
  • Quality Control on the site
  • Drug control for studies
  • File control for studies
  • Management and attention of audits
  • Co-ordination with all service units within sites and in between sites
  • Patient recruitment and retention strategies
  • Central laboratory within SMO sites
  • Centralized databases
  • Data analytics of diseases, researchers and site capacities
  • Drug control for studies
  • Our project managers and site coordinators will maintain a close follow-up with internal departments and communicate with the sponsor and institutional partners transparently on project updates at all stages of project execution.
  • Our expertise includes:
    1. Project managers with hands-on experience
    2. Single point of contact for accountability
    3. Therapeutic area experts
    4. Trained on GCP
    5. Global regulatory experience
    6. Predefined Risk Mitigation strategies
  • We ensure adherence to our customer’s requirements and applicable global regulations such as COFEPRIS, FDA, EMA, ANVISA, ISP-Chile, INVIMA, MHRA and others
  • Our services comply with Good Clinical Practices (GCP), Good Laboratory Practice (GLP) and the International Conference on Harmonization (ICH)
  • Our promise to continuous quality and improvement allows us to create a strong system of corrective and preventive actions (CAPA)
  • Our team investigates deviations, discrepancies, incidents, etc., and works proactively to detect, correct and prevent actions in time and with accurate documentation