YOU ARE

A company active in the healthcare sector, a clinical center/investigator, a health league/NGO...
...willing to:
  • Conceive a clinical study that is compliant with ethical and regulatory requirements
  • Prepare the documentation to obtain the authorisation to run the study

WE OFFER YOU

Consulting
  • ​Medical need identification
  • Literature review
  • KOL identification
  • Study scope definition
  • Study outcomes selection
  • Clinical study authorisation  procedures                                         
Medical writing 
  • Literature digest
  • Study synopsis
  • Clinical study authorisation file (study protocol, informed consent form, questionnaires for participants and HCPs, participants' diaries)
  • Study report
  • Scientific publication and whitepaper

Please download our flyer and our promotional presentation                         

MEDICAL NEED & KOLs IDENTIFICATION
STUDY DESIGN
PROCEDURES FOR STUDY AUTHORISATION
DOCUMENTATION FOR ETHICS COMMITTEE

OUR APPROACH

You can outsource individual tasks or the overall study conception and submission 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 CE marking submissions 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 & Authorisation of Clinical Studies

BUSINESS CASE 1
Context : A Swiss health league wants to run a clinical study in a public hospital to prove the reliability  and applicability of a wireless-connected medical device for the monitoring of patients affected by a chronic disease.

Vivactis solution & deliverables :

  • Study design (definition of study scope, objectives, outcomes, population…)
  • Principal investigator identification
  • Edition of the study synopsis
  • Edition of the authorisation file for the Ethics Committee (study protocol, informed consent form, case report form, patients & HCPs questionnaires)
  • Study registration on clinicaltrials.gov
  • Electronic study file submission through the Ethics Committee portal.
BUSINESS CASE 2
Context : A Medtech company wants to investigate the usability for the general practitioners of their new medical device for screening purposes.

Vivactis solution & deliverables :

  • Study design
  • Physicians identification and recruitment
  • Authorisation file submission to the Ethics committee
  • Physicians training on the use of the device (development of the training material)
  • Organization of a campaign to recruit patients
  • Scientific publication of the study results.