Clinical Trials

In order to prove the efficacy and/or safety of a product, we design and conduct clinical trials in accordance with the MEDDEV 2.7/4, EN ISO 14155-1:2011, Good Clinical Practice (ICH GCP), regulatory requirements and local legislation.

The Vizera team manages clinical trials for medical devices and nutraceuticals (food supplements, functional food and food for special medical purposes). We also perform clinical trials for pharmaceuticals phase III and IV.

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:

• Diabetes
• Prediabetes
• Gastroenterology
• Obesity
• Immune system
• Osteoarthritis
• Cognitive functions
• Hypertension/Hyperlipidaemia
• Wounds
• Urology
• Gynecology
• Paediatric health
• Probiotics

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

 

 

Clinical Trials for Medical Devices

As a CRO partner to a 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 conduct of clinical trial:

• Designing and writing the protocol that will help you obtain the CE mark
• Designing the Case Report Form and applicable study documents
• Preparation and customization of the Informed Consent Form
• Preparation and maintenance of the Trial Master File
• Selection of clinical sites, principal investigators, and laboratories
• Obtaining ethics committee and competent authority approvals
• Registering the trial in applicable database(s)
• Preparation of a patient recruitment plan and retention strategy
• Organisation of meetings, e.g. investigator meetings and training sessions
• 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
  
  
  

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 laboratories 
• Obtaining ethics committee approvals and performing competent authority notifications
• Preparation of patient recruitment plan and retention strategy
• Organisation of meetings, e.g. investigator meetings and training sessions
• Preparation and distribution of clinical trial documentation 
• Investigational product labelling, use of depot, and distribution services
• Clinical trial coordination and monitoring
• Safety reporting, data management and Statistical analysis 
• Writing final report and/or scientific article

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

Communications regarding the health benefits of food products in the European Union are regulated by the 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 conducting 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 to the EFSA
• Offering support during the EFSA evaluation

If the food is newly developed, innovative food, food produced using new technologies and production processes, or it is / has been traditionally eaten outside of the EU it is considered as a novel food and must be authorized by the EFSA (Novel Food Regulation (EU) 2015/2283). Vizera performs scientific and technical services in order for your product to be authorized as a novel food:

• Designing and conducting clinical trials to show the safety of your product
• Preparing relevant documentation 
• Compiling a dossier for a novel food application submission to the EFSA
• Offering support during the EFSA evaluation
  
  
  

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 competent 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

 

 

Medical Device Regulatory Services

Before a medical device is introduced  to the market it must obtain the CE mark. Vizera  is experienced in clinical evaluation report preparation as well as complete technical documentation. Vizera also helps you to make the right decisions on how to register your product in the EU in order to avoid incurring additional time and financial costs.

Regulatory Services For Nutraceuticals

Would you like that your nutraceutical product stands out with registered health claim or as a novel food? Vizera prepares the product health claim and novel food application.