Libra Medical, Inc. provides full clinical life cycle contract research organization services and innovative clinical data management solutions to the Regulatory Affairs, Clinical Research, and Quality Assurance functions within life science (Medical Device, Biotech, and Pharmaceutical)companies. Our clients include well-established global medical device companies as well as emerging medical device companies.
Clinical Data and Study Management System
MAESTRO CTMS/CDMS
Easy to use EDC or Paper CRF system available for licensing
Completely turnkey and hosted by Libra Medical
Clinical:
We can assist in designing and running GCP and postmarket Clinical Trials. We have developed protocols, CRFs and run the study from start to finish.
Regulatory
Experienced in getting approvals in major markets around the world including US (PMA, IDE, 510(k)), EU (Design Dossier, Technical File), Canada, and Australia.
Quality Systems
Have developed first class quality systems that facilitates creativity and acceleration of time lines rather than slowing the process down. Have gone through multiple audits and inspection with no non-conformities.
Specialties
Provide an integrated approach to Regulatory, Clinical and Quality so the three departments work together synergistically for faster path to market. Host, design, and manage (turnkey) clinical database for all types of studies.
Specialties
Contract Research Organization, CRO, Regulatory Affairs, Clinical Research, Quality Assurance, Clinical Trial Management Software
