FDA Inspected
BECRO Ltd was inspected by US FDA, recently, and the outcome of the inspection was positive: "No regulatory violations were found during the inspection."
Welcome to BECRO
An independent contract services organization (CRO) founded by professionals with research & clinical experience in academia, regulatory authorities & pharmaceutical industry in order to promote excellence in clinical research
Location
BECRO is based in Greece and Cyprus, which are European Union members, and all our activities are subjected to inspections by European & National Regulatory Authorities
Services
BECRO operates by providing high quality Services to Pharmaceutical industry
Conducting Clinical Trials
BECRO was approved by ΕΟΦ (EOF), the Hellenic Organization for Medicines, a member of EMA, in Conducting Clinical Trials after evaluation according
to current legislation
EOF Registration Number:
118-C-17
Medical Advisor Services
A panel of medical advisors provide services in: haematology, oncology, cardiovascular diseases – hypertension, nephrology, autoimmune diseases – rheumatology, gynaecology, dermatology, pulmonary diseases, metabolic disorders – diabetes mellitus – osteoporosis, neurology, ophthalmology
ISO 14155:2011
ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. It specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices
Standard Operating Procedures
All provided services are according to a set of Standard Operating Procedures (SOPs), embraced by all members of the Organization
