CLINICAL OPERATIONS

From early Feasibility Trials to Post Market Clinical Follow-Up (PMCF) Studies, MedPass’ clinical operations teams specialized in medical devices provide comprehensive support

Clinical Investigations represent a significant investment for medical device companies so it is crucial to ensure that high quality data is obtained in a timely manner and within budget.

Whether the need is for partial or full clinical operations support, MedPass has the flexibility to adapt our services on an as needed basis.

Our clinical operations teams are highly skilled and experienced in project management, site management and monitoring, and safety management. Furthermore, our multi-lingual clinical staff trained in ICH GCP and ISO 14155 are based across the EU. Moreover, we have a proven track record of successful audits by FDA and various EU Member State Competent Authorities.

Our clinical operations processes from regulatory submissions to site close-out are in full compliance with ISO 14155, ISO 13485, 21 CFR 820 and include :

Site Selection and Qualification

We ensure we have a clear understanding of sponsor and study requirements to ensure optimal site selection.

Site Contracts

MedPass’ regulatory team includes staff with legal backgrounds to streamline the contracting process with sites and investigators.

Site Initiation (SIVs) and Support Visits/Staff Training

Our clinical teams use an Interactive approach during Site Initiation and Training Visits to identify site-specific processes, identify any gaps or risks to study execution, and find solutions to mitigate issues that may arise during the course of the trial.

Site Management and Monitoring

Our CRAs are senior with robust medical device training and experience and allocated on the basis of geographical location and therapeutic area.

Our staff is also specially trained in remote monitoring and risk-based monitoring

Clinical Project Management

The MedPass Clinical Project Manager (CPM) acts as the client’s main point of contact. Our focus is on proactive project management based on key project milestones.

MedPass CPMs are trained to practice data-driven clinical project management using weekly reports generated from EDC to stay on top of key metrics such as patient enrollment, record status, AEs/SAEs, protocol deviations and query status.

Communication plans developed for projects by the MedPass CPM ensure clear, consistent communication between team members and shared goals and timelines.

Safety Management and Reporting

Our specialized Safety group is expert in AE/SAE handling and safety reporting requirements for medical device clinical trials.

Global Project Management

MedPass has expertise in the set up and management of CECs and DSMBs and can also manage other specialist groups such as Core Labs and CROs outside of the EU.