FDA Inspected

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."

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GCP

GCP

BECRO operates according to the GCP and ICH guidelines, the Declaration of Helsinki and all currently standing rules and legislation governing regulatory and ethical aspects whenever ...

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ISO 9001:2015

ISO 9001:2015

The Quality Management System (QMS) of BECRO Ltd has been assessed and approved by IQS Standards Division. The registered scope of the QMS is: Contract Research ...

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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

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

ΕΟΦ

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

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

Accessibility Toolbar

Recently, US FDA Inspected BECRO for one more time, and the Outcome of the Inspection was again Positive with No Observations.

The aim of the FDA Inspection was to determine whether the activities and procedures of BECRO complied with 21 CFR Part 320 - Bioavailability and Bioequivalence (BE). In particular, FDA conducted this inspection to ensure that data and information submitted to FDA by BECRO are scientifically valid and reliable and also, to ensure that the rights, welfare, and safety of research subjects are protected during the study of investigational products.

Note that BECRO is one of the very few CROs with No Observations in all FDA Inspections.

BECRO is specialized in the conduct of:

  • Therapeutic Equivalent (Non-Inferiority) studies (Bioequivalence studies with Clinical End-points) for Topical Generic products:
    • Ophthalmic (leading CRO in Europe), Inhalers, Dermatological, Anesthetics and NSAIDs, Suppositories, Nasal, Otic.
  • Bioavailability and Bioequivalence Pharmacokinetic studies.
  • Clinical investigations for Medical Devices.
  • Monitoring services.

Also, BECRO specializes in drafting modules of CDT and CERs for Medical Devices, and in preparing CDT and CDISC for US FDA submissions.

BECRO will continue to provide high quality services to our Sponsors.