Let's prove it.

Clinical Trials

In order to prove the efficacy and/or safety of a product, we design and conduct clinical trials in accordance with the Good Clinical Practice (ICH GCP), regulatory requirements and local legislation.

The Vizera team manages clinical trials for pharmaceuticals, nutraceuticals (food supplements, functional food and food for special medical purposes), and medical devices. Our carefully selected and well-trained staff have extensive experience in the design and implementation of a wide range of clinical trials in all major therapeutic areas, with particular expertise in the following fields:

  • Gastroenterology
  • Obesity
  • Cognitive functions
  • Hypertension/Hyperlipidaemia
  • Immune system
  • Oncology
  • Dermatology
  • Paediatric health
  • Probiotics

We have established a strong and wide-reaching network of investigator and clinical sites in Slovenia, Croatia and Serbia.

 

 

Clinical Trials for Pharmaceuticals

As a CRO partner we provide the following clinical trial management services for pharmaceutical products:

  • Preparation of clinical documentation in local languages
  • Submissions to ethics committees and regulatory authorities 
  • Selection of clinical sites, principal investigators and accredited laboratories
  • Customization and translation of Informed Consent Form
  • Organisation of meetings, e.g. investigator meetings and training sessions
  • Patient recruitment plan and retention strategy 
  • Investigational product and clinical material depot, and logistics services
  • Site management and monitoring
  • Pharmacovigilance

 

 

Clinical Trials for Nutraceuticals

Enhance the value of your product with clinically proven efficacy.

In order to demonstrate the safety and/or efficacy of your product, our team offers the following services for the implementation of clinical trial:

  • Designing and writing the protocol, taking the nature of the product into consideration (optimal trial design for the targeted population, calculation of sample size, etc.)
  • Selection of clinical sites, principal investigators and accredited laboratories 
  • Obtaining ethics committee approvals and performing authority notifications
  • Preparation of patient recruitment plan and retention strategy
  • Preparation and distribution of clinical trial documentation 
  • Investigational product labelling, use of depot, and distribution services
  • Clinical trial coordination and monitoring
  • Pharmacovigilance
  • Data management and statistical analysis 
  • Writing final report and/or scientific article

We will advise you on the best possible way to obtain EFSA confirmation of health claim for your product. 

Communications regarding the health benefits of food products in the European Union are regulated by EC directive 1924/2006. The EU Commission must approve any health claims before they may be used in the wording of the label. 

Vizera provides scientific and technical support in order to obtain approval for your product’s health claims:

  • Composing the wording of the claim 
  • Designing and implementing clinical trials to substantiate the product’s health claims
  • Preparing relevant documentation for the purpose of substantiating health claims
  • Compiling a dossier for a health claim submission
  • Offering support during the EFSA evaluation

 

 

Clinical Trials for Medical Devices

As a CRO partner to medical device manufacturer, we can offer local support and management for the multinational trial, or we can design and conduct a tailor-made trial for you to support you with obtaining the CE mark.

In order to demonstrate the safety and efficacy of your product our team offers the following services for the implementation of clinical trial:

  • Designing and writing the protocol that will help you obtain CE mark
  • Designing CRF and applicable study documents
  • Preparation and customization of Informed Consent Form
  • Preparation and maintenance of Trial Master File
  • Selection of clinical sites, principal investigators, and accredited laboratories
  • Obtaining ethics committee and regulatory authority approvals
  • Registering the trial in applicable database(s)
  • Preparation of a patient recruitment plan and retention strategy
  • Investigational product labelling, import documentation, use of depot, and distribution services
  • Clinical trial coordination and monitoring
  • Safety reporting and malfunction/complaints management
  • Data management and statistical analysis
  • Writing of final report

 

 

Business Enquiry

If you are interested in finding out more about a clinical trial for pharmaceuticals or nutraceuticals, you are kindly invited to complete the enquiry form or send us an e-mail. All information you provide will be kept strictly confidential.

Research and development

Research and Development

Vizera’s project managers and experts work in a wide range of product development areas and are completely focused on achieving their goals regarding the development of pharmaceutical and nutraceutical products – from the initial concept right through to registration.

Regulatory affairs

Regulatory Affairs

Before a product can be used, sold, supplied, advertised or stored, it must be approved for use. Vizera helps you make the right decisions on how to register your product in the EU in order to avoid incurring additional time and financial costs.

1.First name *
2.Surname *
3.E-mail *
4.Telephone *
5.Company name *
6. What type of clinical trial would you like to perform?
7.Please provide us with basic information about your product (i.e. indication, active ingredient, formulation)
8.What is the dosing regimen (unit dose, frequeny, loading dose)?
9.What is your target population for testing the product?
10.If already defined, what is the expected sample size?
11.If defined, what are the most important inclusion and exclusion criteria for the participants?
12.If already defined, what are the primary and secondary outcome measures?
13.Do you have any requests about the study design (e.g. treatment period, study type)?