MEDTECH FULL CLINICAL TRIAL MANAGEMENT

Meditrial is a full-service CRO partner with a remarkable record of 100% success in assisting clients to execute studies in medical centers of excellence throughout Europe.

Site Selection

Prior to the initiation of the clinical trial, the qualifications of the principal investigator and adequacy of the site must be verified and documented in an investigation site selection report. Sounds complicated? No worries, Meditrial knows how to select the right site for your trials.

Study Approval

Obtaining an approval for your study could be tricky if you get lost in submitting relevant study documents to competent authorities and ethic committees. Meditrial will follow every step for you from start-up study to completion.

Site Initiation

Our specialized team can define the activities required for the initiation of investigation sites in accordance with EN ISO 14155. Our monitoring plan seeks to check and document regulatory approval, to complete site opening procedures and prepare for enrollment of the first patient.

Clinical Data Management Biostatistics

Paper CRF are history now, everybody knows that. But we know that not all e-platforms are suitable for clinical data. Our electronic databases allow different types of data review to be performed while carrying out a study. Data review activity can support study data integrity by analysis of results trends and data collection status.

Risk-based Monitoring

There is no clinical trial without risks. Meditrial team will assess and define a risk plan associated with medical devices subjected to clinical investigations, in order to proactively react to those risks and mitigate the effects.

Safety Reporting

Meditrial team is highly skilled to perform procedures reporting modalities for Adverse Events (AEs), Serious Adverse Events (SAEs) and Device Deficiencies during pre-market clinical investigations of Medical Devices and Active Implantable Devices.