What do we do exactly?
RoMonics is a Medical Device consulting group specializing in point-of-care-test (POCT) programs. Located in the Rocky Mountain Region, Colorado we provide assistance in the development of rapid tests for human and animal diseases.
Roy Mondesire, PhD
RoMonics, LLC
5343 Pinehurst Court
Boulder, CO 80301
USA
P: 720-291-7161
E: romonics@msn.com
Regulatory Submission
FDA & ISO
regulatory issues, 510(k) submissions, CE Marking requirements
510(k), IDE, PMA Submissions
Device Import/Export Consulting
Medical Device Directives (CE Marking) Consulting
Clinical Trials
A. Study Design and Protocol Preparation
B. Pre-Submission Fulfillment (Pre-IDE, IDE-clinical trials, 510k or PMA
submissions)
C. Medical Devices Directive (CE- Marking) Submission Process Fulfillment
D. Single or Multi clinical trials selection
E. Coordination of all Clinical Trial Project Activities
Pre-study Activities
» Protocol preparation and all study specific documentation;
(case report forms, IRB submission, etc)
» Protocol
submission
» IRB and ethics committee compliance and submission
» Selection
and coordination of investigator sites
» Facilitate and negotiate investigator contracts
» Coordinate centralized services (E.g. Laboratory services)
» Prepare and monitor Sponsor administrative duties and checklists
» Development
of Study brochure and investigator training material
» Pre-study visits;
(qualification
of clinical site, documentation of site, pre-study training of personnel)
Study Management
» Study Initiation (conduct formal investigator’s
meeting, review documents, training)
Study Monitoring and Termination
» Assess protocol adherence and regulatory compliance,
review source documentation, etc.
» Prepare compliance reports, etc.
» Study termination
Data Analysis and Reporting
» Data Analysis (statistical and clinical)
» Report preparation and review