Clinical Support

Our Clinical team of experts have hands on experience in conducting medical device clinical trials in Global Investigation sites based on regulatory requirements. We offer the below services to our clients

Clinical Trial of Medical Device Study Design and Protocol Development,
Medical Device Clinical Studies based on GCP and ISO 14155 Compliance,
Biostatistics for Medical Device Clinical Studies,
Medical Device Clinical Trial Management and Monitoring,
Clinical Trial Data Management for Medical Devices,
Medical Device Clinical Study Audits and Quality Control,
Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices.

Clinical Evaluation Methodology

Meditix supports you according to your wishes and requirements in the creation of a new clinical evaluation as well as updating your existing clinical evaluation.
We can assist with:

the identification of similar products
the research of clinical data in accepted scientific literature databases
the collection and analysis of existing clinical data
determining the safety and efficiency of your medical device
the reconciliation of your product information with information from the clinical data
evaluating whether new clinical data must be collected (clinical trial)

Clinical Trail Process

Meditix supports you in the implementation of the complex requirements of a clinical trial, and offers many years of experience in the planning and conduct of clinical trials.

Our Study Process is as follows:

Planning & Design
Study Management
Conduct Clinical Trial
Data Management
Biostatistics / Analysis
Evaluation and Reports