Headquarter:
Via Maggio 1C, Lugano 6900,
Switzerland
Contact:
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E-mail: office@cebis-int.com
Phone: +41 91 260 15 75
Global Administrative Hub
Romania- Helios Business Center (HBC) , 47 Bd. Theodor Pallady, Bucharest, Romania

©2019 by CEBIS International - Pivacy Policy Website

ABOUT CEBIS

 

CEBIS International is a Global Swiss-Based Full Service  Contract Research Organization (CRO) which provides clinical stage, regulatory and market entry support to biotech, pharmaceutical, medical devices and nutraceutical companies in already 29 countries. CEBIS headquarters is located in Lugano, Switzerland. CEBIS is offering attractive shared-risk and milestone-based models and aim at long-term partnerships. 

 

CEBIS has two major Business Units — Clinical & Regulatory Services (CRS) Unit and Patient Support Programs (PSP) Unit. The CRS unit cover medical writing, regulatory affairs, monitoring, data management, biostatistics, and publishing, working closely with pharmaceutical, biotechnology, and medical devices companies. On the other hand, the PSP Unit is focused on medication adherence and technology-based interventions. 

 

Industry Standards & Guidelines

We have implemented and adhere to the following guidelines and principles in all our research activities:

  • ICH-GCP (International Conference on Harmonization)

  • Good Clinical Practice

  • Medial Device Regulation(MDR) 2017/745

  • Medical Devices and Regulation(EU) 2017/746

  • ISO 14155:2011 (Clinical investigation of medical devices for human subjects - Good clinical practice)

  • EFSA (European Food Safety Authority)

  • US - Code of Federal Regulation - Title 21 - Food and Drugs

  • General Data protection Regulation (EU) 2016/679

  • Health Insurance Portability and Accountability(HIPAA)

 

Our Clinical Expertise


Our services support the clinical development and product life cycle for: pharmaceutical, biotechnology, medical devices, dietary supplements, food for particular medical purposes and phytochemicals in the following therapeutical areas:​ Oncology, Hematology, HIV-AIDS, CNS, Immunology, Hepathology-Gastroenterology, Ob-Gyn, UTI, ID, Respiratory, Pediatric, Dermatology, Allergology, Rheumatology, Ophthalmology, Intensive Care, Anesthesia

Regulatory Compliance

CEBIS regularly keeps up with the changing

regulatory landscapes across the globe to succeed in all

stages of the drug development. Along with local partners

and its regulatory staff, the company understands the

regulatory framework for each country to support its clinical

research programs.

We are fully conversant and our activities are completely compliant with the regulations of:

  • FDA – U.S. Food and Drug Administration, USA

  • EMA – European Medicines Agency, Europe

  • PMDA – Pharmaceuticals and Medical Devices Agency, Japan

  • ANVISA – Brazil National Health Surveillance Agency, Brazil

  • ROSZDRAVNADZOR – Federal Service for Surveillance in Healthcare, Russia

  • DFDA – Directorate of Food and Drugs Administration, India

  • CFDA – China Food and Drug Administration, China

  • BfArM – Federal Institute for Drugs and Medical Devices, Germany

  • MHRA – The Medicines and Healthcare Products Regulatory Agency, UK

 
 
 

Our Mission

Our mission is to help patients be correctly diagnosed, provide access to the best available treatments and help them to comply with the requirements for administering their treatments ensuring high adherence.

Our Vision

Medication adherence is essential even if the patient is not participating in a clinical trial. Our vision is to become a global leader in clinical research, patient support and treatment adherence technologies. 

 

CEO Message

At CEBIS International we keep our focus on what the patient needs.  Our patient centric approach permeates throughout all our services, whether it is clinical research or our very own patient support programs .

At CEBIS, we help patients access novelty treatments, whether these treatments are in the development phase, or in a post-marketing setting. We understand innovative and high-tech therapies can save a patient's life, and we have the ability to make a significant and positive impact in improving the quality of a patient's life. 

We offer a unique and tailored solution, combined with a technology approach, to help identify and support patients access and adhere to a particular therapy or device.  We accomplish this by working as part of the clinical team, advancing medical science and research, and advocating and supporting patients throughout their treatment journey.  We constantly strive to improve our processes to ultimately optimize patient outcomes. 

Our mission is to actively help patients obtain a correct diagnosis, access the best available treatment and support, to ensure high adherence for optimal clinical results and quality outcomes. 

 

OUR MANAGEMENT TEAM

Alina IORDACHE, RN

Head of Clinical Operations

CEBIS International

Catalin BUNGESCU, MD

Head of Patient Support Programs

CEBIS International

OUR HISTORY TIMELINE