Introduction - BECRO CRO Greece - Contract Services Organization - Clinical Trials - Bioequivalence Studies - Therapeutic Equivalence

Clinical trial services for Generics all the way from study set up to Submission Specialized in Generic products & Medical Devices

An independent contract research organization (CRO) offering start to finish clinical trial/study services. Founded by professionals (including former officials from Regulatory Agencies, the Industry, and Academics) with broad experience and insight in drug development and regulation

BECRO operates by providing high quality Services to Pharmaceutical & Medical Device Companies

BECRO is located in Greece (Athens & Larissa) & Cyprus (Nicosia), European Union members & all our activities are subjected to inspections by European & National Regulatory Authorities

BECRO operates according to the GCP & ICH guidelines, the Declaration of Helsinki & all currently standing rules & legislation governing regulatory & ethical aspects whenever human subject participation is involved

All provided services are according to a set of Standard Operating Procedures (SOPs), embraced by all members of the Organization

A panel of medical advisors provide support in: haematology, oncology, cardiovascular diseases – hypertension, nephrology, autoimmune diseases – rheumatology, pulmonary diseases, metabolic disorders – diabetes mellitus – osteoporosis, neurology, gynaecology, otorhinolaryngology, orthopedics, dermatology, ophthalmology

Why Greece?

Average Study Approval Time	~1month
Regulatory Compliance	According to EMA/FDA/ICH regulations
Fast recruitment rate	For example: in a recent Therapeutic Equivalence study for Latanoprost with 200 patients, the recruitment lasted just three months!
Cost savings	Compared to trials in US and West/North Europe
Excellent Clinical centers	All investigators are GCP qualified and experienced in conducting CTs
Personnel	Ability to hire and retain qualified individuals, good fluency in English

Why BECRO?

Experienced Personnel in Clinical Research and Regulatory affairs	Experience gained after participation in a large number of interventional studies, including Bioequivalence studies. Strong relationships with expert consultants in diverse therapeutic areas Valuable experience in BECRO leadership who are former members of Regulatory Agencies and EMA.
Highly qualified personnel	Two MDs on the staff roster All senior staff with PhD and/or MSc degrees.
Deep expertise in designing and conducting Therapeutic Equivalence Trials and Bioequivalence studies	BECRO leadership have been rapporteurs of EMA for Guidelines documents, including bioequivalence studies. Members of EMA WPs.
Start to finish clinical trial services	Only CRO in Greece offering clinical trials services all the way from study set up to submission.
Excellent Networking	Strong ties with clinics in major university and public hospitals