Clinical Trial Services

CLINICAL TRIAL SERVICES

Cover All Your Needs

Whether your product is in the feasibility stage or you are ready to start a pivotal study to support your submission, at ProMedoss we provide a wide array of clinical trial services that will cover all your needs.

Our services include:

Project management
Investigator identification and recruitment
Study related binders/document preparation
Investigative site management and monitoring
Clinical supplies and CRF storage and shipment
Electronic Data Capture (EDC) Services
Investigator agreement and grant payment management
IRB management
Central laboratory management
Regulatory document/consent form approval and submission
AE/SAE reporting
Medical monitoring
Data Management

“ProMedoss has recently assisted us in submitting a 510(k) for extending the intended use of our cleared device. The regulatory review was smooth, ending with a new clearance within the usual timeframe. We thank ProMedoss for their professional and experienced guidance.”

“I have been working with ProMedoss for the last 5 years using their services for various FDA related submissions as well as Quality related matters. ProMedoss assisted us with an initial pre-sub interaction for our novel stent system and have successfully secured three 510(k)’s for our various EndoGI Biliary Stent Systems.”

“I have been working with Bosmat and Shosh for several years from project initiation to successful FDA clearance. They are high performers with fast reaction time, are familiar with the smallest details of the project and are always ready to assist. I consider them one of my best subcontractors as they provide top level service with a professional attitude and a smile.”