Clinical Trials for Medical Devices

At COSMOS Scientific, Inc., we offer specialized medical writing services tailored to the requirements of medical device development. Our team delivers clear, accurate, and fully compliant documentation, including clinical investigation plans, investigator brochures, informed consent forms, monitoring plans, safety management plans and regulatory submission dossiers, among others. We ensure that all documents adhere to international standards and meet the expectations of national regulatory agencies such as the FDA, EMA, INVIMA, COFEPRIS, ANMAT, ISP, and others.

COSMOS Scientific guides medical device companies through the regulatory approval process  ensuring that clinical trials meet international standards. We  specialize in regulatory strategy and submissions in the United States, Colombia, Panama, Mexico and across other Latin American countries.  Our team ensures full compliance with regional requirements and accelerates approval timelines to support successful trial initiation.

According to the requirements of your clinical protocol we will identify suitable clinical research centers and Key Opinion Leaders that will perform as principal investigators for your clinical trials in multiple clinical research sites in the United States, Colombia, Panama, Mexico and other Latin American countries.

Our team can assist with physician recruitment, management of  multi-center research studies, data collection and site management. Our team customizes our service offerings to meet client needs, from the pre-initiation activities to study close-out. The Clinical Project Manager has a leading role in planning, coordinating and designing a clinical project management plan to ensure successful project delivery. 

Our Clinical Research Associates monitor our sites on a regular basis to ensure that the study protocols are being adhered to. COSMOS Scientific will monitor the site and attend Pre-Study Selection Visits (PSSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV) and Study Closeout Visits (SCV) on behalf of the Investigator or the Sponsor. Follow-up reports are sent to the Site and Sponsor to ensure queries are resolved and information is consistent.

We understand that issues with subjects recruitment and enrollment are the primary causes for missing clinical trial timelines. COSMOS Scientific is aware that sponsors and CROs are looking to any and all means by which they can increase patient enrollment rates. COSMOS Scientific designs customized and successful patients recruitment strategies.