clinical

Axis HealthCare has partnered with the School of Medicine of Universidad de Antioquia, one of the most distinguished clinical research institutions of Colombia, for conducting clinical trials in support of global regulatory submission.  This Partnership ensures Axis HealthCare full capability in the conduct of clinical trials.

  • Guarantees a detailed research plan that includes the definition of objectives, background, and rationale; subject selection criteria, treatment plan, study procedures, response evaluation criteria, and a statistical section.
  • Capturing local / regional clinical trial idiosyncrasies and ensure alignment with international ethical and scientific quality standard for the design, conduct, and recording trials that involve human subjects.
  • Identifying and weighing the risks against anticipated clinical trial benefits.
  • Maintenance of training and monitoring of good clinical practices at chosen sites.
  • Understanding and putting into perspective the legal and ethical issues surrounding GCP in a particular site / country.
  • Taking measures to minimize the risk of deviations from GCP.
    • providing a unified standard for clinical data.
    • ensuring that lower level researching understands the baselines.
  • Identifying qualified investigators to conduct the trial and qualified persons to provide medical care.
  • Handling, storage, and administration of the drug in accordance with the defined protocols.
  • Making recommendations on ways to achieve greater regional harmonization in the interpretation and application of technical guidelines and requirements for product registration.
  • Reducing the need to duplicate the testing carried out during the Global research and development of new medicines on the regional level.