At Glance

0 years
experience on the Clinical Research Global Market

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.

  • 01

    Medical Writing (eg: Protocol, Investigator Brochures (IBs), CRF, ICF)
  • 02

    Regulatory & EC/ IRB Approvals
  • 03

    Clinical Trials (Initial Submission, Amendments, Annual Reports, Follow-up, GCP trainings)
  • 04

    Monitoring (Site Initiation Visit, Site Monitoring Visits, For-cause Visits, Close-out Visit, Audit Visits, Co-monitoring Visits, Risk-based Monitoring, Inspection Readiness Visits)
  • 05

    Data Management (Data Coding, Data Cleaning, Data Validation, Database Lock)
  • 06

    Biostatistics (Data Analysis, Data Report, Data Interpretation)
  • 07

    Publishing (Article Writing, Poster design, Abstract Preparation, Article Adaption to Journal Requirements, Follow-up Until Publication)
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CLINICAL TRIALS
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sites
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PATIENTS

OVERALL CLINICAL EXPERTISE BY THERAPEUTIC AREA

Drugs & Biologics
ICH-GCP Guidelines



Phase II-IV Interventional Studies

Observational
Studies

Medical Devices
ISO 14155-2011 PMCF (Med DEV 2.12.2) CER (MED DEV 2.7.1)

Regulatory Interventional Studies (before the CE Mark)
Observational Studies (after CE Mark)

Food Supplements
EFSA Guidelines



New Claim Approval Studies

Food Research &
Evaluation Studies

CEBIS CERTIFICATIONS

ISO 27001:2013 – Management Systems for Information Security appliable for all CEBIS divisions.

ISO 13485:2016 – QMS for Medical Devices.

ISO 22301:2020 – Security and resilience — Business continuity management systems appliable for all CEBIS divisions.

ISO 45001:2018 – Occupational health and safety management systems appliable for all CEBIS divisions.

ISO 9001:2015 – Quality management systems appliable for all CEBIS divisions.

ISO 14001:2015 – Environmental management systems appliable for all CEBIS divisions.

ISO 27017:2015 – Information technology — Security techniques — Code of practice for information security controls based on ISO/IEC 27002 for cloud services.

ISO 27018:2015 – Information technology — Security techniques — Code of practice for protection of personally identifiable information (PII) in public clouds acting as PII processors.

Qualified, Trained
&
Experienced Professionals

Ethics, Compliance, PV & Regulatory Requirements Followed in Business Conduct

Human
&
Technology Based Interventions

Following through on our commitment to address customers' needs we achieve excellence, being recognized by patients and other stakeholders as the company offering high quality services.

“A reliable partner delivering comprehensive services with expertise, efficiency, and integrity”

“Scientific expertise and experience to provide the highest quality in the pharmaceutical research field“

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CEBIS Interantional

Romania- Helios Business Center (HBC),
47 Bd. Theodor Pallady,
Bucharest, Romania