Clinical Research

We offer custom-tailored Services

Clinical Research

Our experienced Clinical Research Team will be pleased to support you. We can provide solutions tailored to your requirements in the following fields:

 

Our assets

  • Drug development
  • Strategy and regulatory requirement
  • Familiar with demanding study designs
  • Experience with complex organisations
  • Privileged contacts to OPLs
  • High quality standards
  • Operate in all European countries
  • Legal Representation for Switzerland and the EU

Our services

  • Phase I to IV, Epidemiology
  • Study Design
  • Scientific Advice
  • Authorities, Ethics Committees
  • Monitoring
  • Statistics, eCRFs
  • CSRs / Publications
  • QA, Audits
  • Pharmacovigilance
  • Support in Fund Raising

Medical Writing

  • Case Report Forms
  • Patient Information and Consent Forms
  • Clinical Study Protocols
  • Clinical Study Reports
  • Investigator’s Brochures including Preclinical Evaluation
  • Clinical Overviews
  • Clinical Summaries
  • Publications

 

Drug Development

  • If you are in Drug Development approaching Phase I or searching for a flexible and efficient CRO we are your partner
  • The European CRO
    Five Office Ltd Switzerland
    Five Office s.r.o. Slovak Republic

Trainings

  • Five Office Ltd is an accredited Trainings Center for pharmaceutical medicine (category B) of SGPM (associated to the FMH Swiss Medical Association) and SwAPP

Therapeutic Indications

 

Your Clinical Study at Five Office Ltd is moving fast, safe, cost-efficient, driven by dedicated CRAs, appreciated by the centres.

 

Contact us now     Contact us for support in Clinical Research

 

 

 

 

Our highlights

Clinical development of a biosimilar in Switzerland and Europe

Bemfola® (development code: AFOLIA; follitropin alfa solution), r-FSH, sponsor Finox AG, Switzerland.
Five Office Ltd has been entrusted with the study design, the selection and the collaboration with the main investigator, as well as the conduct of this large phase III study in 6 European countries. Bemfola® has been approved by the EMA in March 2014.

One year later, in March 2015, the US FDA approved Zarxio® (filgrastim-sndz), the first biosimilar on the US market.

To close the circle: Zarxio® is a biosimilar to Neupogen® for which Five Office Ltd was in charge of the scientific information management when it was licensed to Roche. 

 

Examples of Category A
(Phase IV, observational)

  • CHOICE NuvaRing® (Etonogestrel, Ethinylestradiol)
    MSD: several Publications
  • Palexia® (Tapentadol)
    Grünenthal: publication submitted
  • SWISS HYPE Amelior® (Olmesartanmedoxomil and Amlodipin)
    Menarini: publication

Example of Category B
(Phase IV)

  • Meningitec® (Neisseria meningitidis)
    Wyeth: national vaccination
    recommendation obtained

Examples of Category C
(Phase I, II and/or III)

  • Firazyr® (Icatibant)
    Jerini: on the market
  • Xiapex® (Collagenase clostridium histolyticum)
    Auxilium: on the market
  • Bemfola® (development code: AFOLIA; follitropin alfa solution)
    Finox: approved by the EMA

 

Five Office Ltd: innovative, efficient and reliable.

 

CONTACT US NOW     Contact us for support in Clinical Research

 

 

Contact Details

Five Office Ltd

Guyer-Zeller-Strasse 10

8620 Wetzikon

Switzerland

 

Tel.: +41 44 932 30 32

Email: welcome@five.ch

Five Office s.r.o.

Dankovskeho 4

SK-811 03 Bratislava

Slovak Republic

 

Tel.: +41 44 932 30 32

Email: engel@five-office.com