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.
Context: A Swiss start-up in the Medtech field has recently launched a medical device for screening purposes. Vivactis is mandated to plan a post-marketing study to evaluate the applicability of such a device for general practitioners.
Objective: Design a study in order to obtain data to support the introduction of the medical device in a cancer screening program. Strategy & deliverables:
Define the type of study to be conducted, define the statistical plan
Identify physicians willing to participate in the study
Prepare all the documentation for submission to the ethics committee (protocol, case report form, informed consent form)
Train the physicians to the use of the device
Organize a screening day campaign to recruit patients
Develop a questionnaire to evaluate how the device is perceived by both the physicians and the patients
Context: A Swiss health association is willing to run an observational study in collaboration with a public hospital and a Swiss start-up to test the reliability and applicability of a wireless-connected device for the monitoring of patients both at the hospital and at home. Vivactis is mandated to plan a pilot study at the hospital and a larger study with patients at home.
Objectives: Design two clinical studies in order to gather data to support the introduction of the wireless-connected device for the monitoring of patients both in the hospital and at home. Strategy & deliverables
Define the type of studies to be conducted
Fundraising: prepare the documentation for submission (scientific and financial aspects)
Ethics committee: prepare the documentation for submission (protocol, case report form, informed consent form)
Develop a questionnaire to evaluate how the device is perceived by both the healthcare professionals and the patients
Write the final study report
Vivactis (Suisse) SA - Biopôle, Croisettes sect., SC-A building, Rte de la Corniche 4, 1066 Epalinges - Switzerland | Email: firstname.lastname@example.org | Phone: +41 21 311 62 73