Libra Medical
www.libramed.comLibra 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.
Read moreLibra 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.
Read moreCountry
State
Minnesota
City (Headquarters)
Brooklyn Park
Industry
Employees
11-50
Founded
2007
Estimated Revenue
$1,000,000 to $5,000,000
Social
Employees statistics
View all employeesPotential Decision Makers
Chief Executive Officer
Email ****** @****.comPhone (***) ****-****Regulatory and Clinical Consultant
Email ****** @****.comPhone (***) ****-****Regulatory Affairs Consultant
Email ****** @****.comPhone (***) ****-****Clinical Data Analyst
Email ****** @****.comPhone (***) ****-****
Technologies
(14)