YOU ARE

A company active in Pharma, Biotech, or Medtech, a health league, a hospital or a private clinic willing to:
  • Prove the reliability and cost-eff ectiveness of your product versus gold standard methods
  • Evaluate the usability and applicability of a new technology
…for prevention, diagnosis, treatment & patient follow-up at the hospital or at home.

WE OFFER YOU

Consulting services
  • Market characterization
  • Medical need & feasibility surveys
  • Literature review
  • Study design
  • KOLs & investigational site identification
  • Procedures for clinical trial authorisation                                           
Medical writing services
  • Survey and analysis reports
  • Documentation for submission to the Ethics Committee
  • Scientific reports and publications

Please download our flyer                         

KOLs & STUDY SITE IDENTIFICATION
STUDY DESIGN
PROCEDURES FOR STUDY AUTHORISATION
DOCUMENTATION FOR ETHICS COMMITTEE

OUR APPROACH

You can outsource individual tasks or the overall study design to us. Vivactis helps you plan your study from the design to the reporting phase, in order to be compliant with regulatory and ethical requirements.

For other studies for regulatory perspectives, CE marking submission, or medico-economic analyses for reimbursement strategies, we collaborate with experts from the field, either within the Vivactis Group or outsourced. 

For more information, please contact us !

BUSINESS CASES – Conception of Clinical Studies

BUSINESS CASE 1
Context : A Swiss health association wants to run an observational study at the hospital to prove the reliability of a wireless-connected device for the monitoring of patients affected by a chronic disease..

Vivactis solution & deliverables :

  • Study conception (type of study, number of patients, study outcomes, principal investigator identifi cation…)
  • Study synopsis
  • Edition of the documentation for submission to the Ethics Committee (study protocol, informed consent form, case report form, patients and healthcare professional questionnaires)
  • Final study report.
BUSINESS CASE 2
Context : A Medtech company wants to investigate the usability for general practitioners of their new device for screening purposes.

Vivactis solution & deliverables :

  • Define the type of study to be conducted
  • Identify physicians willing to participate in the study
  • Submission to the Ethics committee
  • Train physicians on the use of the device (development of the training material)
  • Organization of a campaign to recruit patients
  • Scientific publication of the study results.