Clinical Trials

We provide full-service solutions for Phase I-IV clinical research and medical devices. We have clinical experts in over 20 countries and experience in the following therapeutic areas: oncology, CNS, cardiovascular, infectious disease, immunology, rheumatology, pulmonology, endocrinology, gynecology, gastroenterology, nephrology, ophthalmology, urology and dermatology.

 

Project management

 
Biomapas provides comprehensive clinical project management services ranging from single-site studies to global registration trials. Our Project Managers maintain personal ownership of study milestones to ensure the projects are successful, delivered on time and completed within budget. Biomapas’ experienced, flexible and dedicated Project Managers lead all aspects of international and local clinical trials, providing continuous feedback on each step from start to finish. The responsibilities of our Project Managers include:

  • Acting as the primary point of contact for our clients and the project team;
  • Providing clinical development program consulting and road mapping for successful execution;
  • Running in-depth feasibility studies and risk assessment plans for country evaluation, including the regulatory environment, disease prevalence, and patient access;
  • Creating a management framework to optimize project execution;
  • Following-up on project risk management;
  • Ensuring strict compliance to national standards, ICH GCP guidelines, EMA and FDA regulations, assigned SOPs and the trial protocol;
  • Overseeing all functional areas and vendors;
  • Managing site and sponsor communication.

For any inquiry regarding our services, please contact Biomapas Business Development team.

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