We are provider of Clinical Trial and Regulatory Services

A full-service CRO operating in the Balkan region with headquarters in Ljubljana, Slovenia, Vizera is recognized as a reliable partner with the expertise to design and execute fit-for-purpose clinical trials.

Vizera team comprises of passionate and dedicated professionals, with education, knowledge, and expertise from diverse scientific areas (such as pharmacy, (bio)medicine, (micro)biology and more) recognized to be very flexible, responsive and solution oriented. Their main focus is to support their partners in executing clinical trials to specifically answer their question/request and reach their goal. Vizera team is committed to perform the clinical trials in accordance with the Helsinki declaration, EU regulations (MDR, CTR), MDCG documents, standard EN ISO 14155, GCP, and other local regulatory requirements.

Vizera performs clinical trials from small pilot studies to larger multicenter trials phase II-IV including post-market clinical follow up studies, for medicines, medical devices, and nutraceuticals. Their specialty is running studies on vulnerable populations, such as pediatric and geriatric populations. As a part of Medis group, through its owner Medis, pharmaceutical marketing company present in the CSEE region and a sponsor of The International Medis Awards for Medical Research (for best applied research achievements in selected areas of medicine), Vizera has established a network of excellent, clinical research-oriented investigators, sites and KOLs, which is complemented by the expertise of the team of GMP, PhV and many other professionals. Thus, their strong and wide-reaching network of renowned experts and investigators provides a rich treasury of knowledge, creating optimal results.

Besides the full range of clinical trial services, Vizera is recognized as a reliable partner and provider of consultancy and regulatory services for (pharmaco) vigilance, registration of products, medical writing, dossier and technical documentation preparation.

As an independent local company, Vizera is not limited to a complex internal structure. This makes Vizera team flexible in providing you services that are tailored to your exact needs and allows for competitive pricing.

Clinical Trial Services - Vizera provides tailor-made clinical trial services.

Study start-up – Study design

  • Protocol preparation
  • Sample size calculation and statistical analysis plan
  • Randomization and blinding
  • Preparation of CRF and other relevant trial documentation (patient diary, questionnaires, IBs…)
  • Preparation of ICF
  • Preparation and maintenance of Trial Master File (TMF)
  • Design and implementation of EDC (eCRF) and ePRO system

Regulatory compliance

  • Preparation of the application for clinical trial approval for the Ethics Committee and Competent Authority with all amendments, regular reporting and end-of study notification
  • Support in the process of the assessment of the application
  • Registration of clinical trials in the database (e.g. EudraCT, CTIS, Eudamed Clinicaltrials.gov…)
  • Safety reporting

Clinical Trial Site Management

  • Feasibility and sites/(principal) investigators selection and certified laboratory selection
  • Cooperation with experienced investigators and laboratories
  • Training of clinical trial staff
  • Kick-off and investigators' meeting organization
  • Site contracting and payments
  • Clinical trial sites management, including site initiations, monitorings (centralized, off-site and on-site), site overview and close-out activities
  • Subject enrollment oversight and support

Project Management

  • Essential project plans, including recruitment plan, risk-based monitoring plan, data management plan, etc
  • Time tracking and status reporting
  • Safety management (AE/SAE reporting, DSUR/PSUR reporting)
  • Budget management
  • Timeline management
  • Risk management

Clinical Trial Logistics & Warehousing

  • Study product (SP: Investigational product (IP), Comparator, placebo) logistics
  • Ancillary supplies and equipment logistics
  • Biosamples logistics
  • GMP secondary packaging and warehouse facility for SP in Slovenia

Data Management and Biostatistics

  • Cooperation with experienced and independent biostatistician team Complete data management
  • Preparation of interim, safety and final reports
  • Preparation of articles for publication in SCI International Journals

Regulatory Services

Vizera helps you make the right decision on how to make a successful launch of your product. Each product category brings different challenges and opportunities.

We are offering regulatory services for the following categories of products: medicines, medical devices, food supplements and other foods, health claims, and novel food.

Regulatory services for medicines

  • Preparation of documentation for marketing authorization approval
  • Support with the marketing authorization procedure at the competent authority
  • Translation of SmPC and PIL
  • Label preparation
  • Being a legal representative of a sponsor of a clinical trial
  • Pharmacovigilance

Regulatory services for medical devices

  • Being an authorized representative in EU
  • Being a legal representative of a sponsor of a clinical trial
  • Registration of medical devices
  • Translation of Instructions for use
  • Label preparation
  • Classification of medical devices
  • Preparation of additional documentation for justification for classification of medical devices
  • Preparation of Clinical evaluation report
  • Preparation of Technical documentation
  • Preparation of Risk analysis & Risk assessment
  • Preparation of Gap Analysis of Technical documentation and Clinical evaluation report
  • Planning and implementing of PMCF
  • Planning and implementing of Post-market surveillance system
  • Vigilance
  • Support with Notified body selection
  • Support with the conformity assessment procedure at the Notified body

Regulatory services for food supplements and other foods

  • Preparation of preclinical and clinical scientific data to evaluate safety and efficacy
  • Design and conduct of clinical trials
  • Label preparation
  • Preparation of documentation for notification at the competent authority, where applicable (foods for special medical purposes, infant formulas)
  • Nutrivigilance

Regulatory services to obtain health claims

  • Composition of the text of the claim
  • Gap analysis
  • Design and conduct of clinical trials needed to prove the health claim
  • Preparation of the relevant documentation (other clinical and non-clinical data to substantiate the health claim)
  • Preparation of the application for authorization of the health claim at EFSA
  • Preparation of the application for authorization of the health claim at EFSA

Regulatory services to register novel food

  • Design and conduct of clinical trials in order to prove safety
  • Preparation of the relevant documentation
  • Gap analysis
  • Preparation of a dossier for novel food safety assessment at EFSA
  • Support during the assessment process at EFSA

About Clinical Trials Innovation Programme 2022

Clinical Trials Innovation Programme is an invitation-only, premium event bringing together a mix of clinical research professionals and service providers in one stimulating environment.

Join us face to face to learn from the best in the drug development industry and have an opportunity to learn from their experiences. With an agenda covering the future of Clinical trials and drug development post COVID, Clinical Trials Innovation Programme 2022 will feature tailored sessions presented by the leading experts from across the globe.

We are bringing together the best in the industry to help you learn and grow, and accelerate your drug development journey. The experts will include thought leaders and visionaries from Danish Medicines Agency, Bayer Pharmaceuticals, AstraZeneca The Janssen Pharmaceutical Companies of Johnson & Johnson, Travere Therapeutics, Biogen, Vifor Pharma, Medical Products Agency and much more.

Register with us to learn more!