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
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
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 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.
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.
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.