MEDICAL DEVICE


Project Managers are assigned to your study based on their experience and familiarity with your specific therapeutic area and indication. This prevents costly data errors due to misunderstandings and provides effective communication between the sites, CRAs, Project Managers and most importantly, the sponsors staff and Project Management team.

Our clinical monitors are chosen for their experience in Clinical Research and the appropriate therapeutic area and also for their high level of commitment to the clinical development of medical devices. This means you can rely on the quality of clinical monitors assigned to your study.

ADAX monitors perform all activities related to pre-trial/qualification visits, initiation visits, interim monitoring visits and close-out visits, ensuring compliance to the protocol and all regulatory requirements. They also maintain strong and constructive relationships with investigative sites to ensure successful trial progress.

ADAX can act as a legal representative in Europe for clients without a legal entity in EU.

THIS IS WHAT WE CAN DELIVER:

Clinical Management
Feasibility and Site Selection
Project Management
Medical Writing
Regulatory Support
Clinical Monitoring
Vigilance
Quality Assurance
Data Management
Vendor Management
 

OUR ADVANTAGES :

  • Short Start up period
  • Experience in specifics of Medical Device Clinical Trials
  • Wide Therapeutic experience
  • Experts on Medical device requirements

THERAPEUTIC EXPERIENCE :

  • Type I diabetes - Glycemic control by continuous glucose monitoring system
  • Type I diabetes - Controlling the amount of hemoglobin HbA1c with insulin pump
  • Neurosurgery - Hernia disci
  • Traumatology - Rotator cuff tear
  • Oncology - Prostate cancer radiotherapy
  • Orthopedics - Halux Valgus

Read more in our Publication: Medical Device – Clinical Investigation and Clinical Evaluation.