EU MEDICAL DEVICE CRO SERVICES

If the goal is to conduct clinical trials to obtain CE marking, MedPass has the staffing and systems in place to offer an almost “turn-key” approach to completing trials on time and in budget, and getting the statistical analysis completed for the final regulatory report.

MedPass’ core activity is our CRO service. Our Clinical Operations Group includes highly skilled project managers and clinical monitors with significant medical device experience. Project teams are assembled to meet the needs of the trial in terms of therapeutic area and geographical location of investigational sites. Project managers coordinate internally with other specialized departments within MedPass as required (Regulatory Affairs, Biometrics) to offer a single point of contact and a seamless service to the client.

MedPass can also provide global project management by organizing and managing outside support from corelabs, CECs, DSMBs, etc. Our clinical trials experience is broad, ranging from First in Man, through CE marking studies and post market registries and clinical trials in Europe to support US FDA 510(k) or PMA requirements. Clinical sites we have managed have undergone successful audits by regulatory authorities including the US FDA and various EU Competent Authorities.

Trial management
Investigational Plan
Informed Consent
Case Report Forms
Monitoring Plans
Site Identification and Qualification
Overseeing Site and Data Management
Core Lab Management
DSMB/CEC Management
Investigator Meeting Planning

Site Management
Site selection and pre-qualification support
Training on Clinical Investigational Plan and specific study procedures
Site management during study start-up and enrolment

Monitoring

ICH/GCP compliant
Extensive knowledge of medical devices across a wide range of therapeutic areas