Welcome!

We are the CRO you’ve been looking for

We believe in a personal approach, professionalism, transparency, proactivity in overcoming challenges, speed, and out-of-the-box solutions.

Each team member has a unique area of expertise

Our Company

We are a team of passionate professionals with over 20 years of experience in clinical studies, regulatory services, pharmacovigilance, and data management. What drives us is our love for what we do and our deep understanding of the industry.

Clinical Trials

Need to test your hypothesis?

Clinical trials are the bread and butter of our operations

  • Comprehensive services from study design and protocol development to the final report
  • Experience in all phases of clinical trials
  • A wide portfolio of therapeutic areas
  • Whether you are looking for just a single service or full study execution, we will create a tailored solution for your needs

Medical Devices

Is your medical device in a critical phase?

Let us energize it!

  • Expert guidance through the entire medical device lifecycle
  • Preparation of all necessary technical documentation
  • Assistance with obtaining a CE mark or Notified Body Opinion
  • Quality management consultancy
  • PMS and PMCF activities

Regulatory affairs

Lost in regulations?

No worries, we are local experts here

  • Regulatory Applications & Submissions: clinical trials regulatory, marketing authorization applications or transfers, product lifecycle management, creation and updates of CMC module, medical writing
  • Regulatory Operations: artwork and labelling, dossier publishing, translations and linguistic reviews, readability, and user testing
  • Regulatory Consulting: consultancy for preclinical and clinical development, regulatory strategy planning, dossier development

Pharmacovigilance

Be safe!

Safety doesn't happen by accident

  • Comprehensive pharmacovigilance services for clinical trials of medicinal products and medical devices, ensuring timely reporting to regulatory authorities
  • Management of pharmacovigilance system for registered products, including QPPV and LPPV services, case processing, literature surveillance, and medical writing

Talent placement

Is this seat taken?

We have just the right person for you

  • Providing experienced professionals who seamlessly integrate into your team, offering specialized expertise to support your projects and goals

Quality assurance

Searching for premium quality?

We do things right when no one is looking

  • Conducting independent audits of sites, CROs, and other vendors
  • Supporting inspection readiness activities
  • Performing independent quality oversight visits or assessments
  • Supporting Quality Management System set-up and maintenance

Data Management & Statistics

Trying to boost your chances?

It’s more probable with accurate data and an experienced statistician

  • Comprehensive data management and analysis services, from sample size calculation to final statistical reporting
  • CRF and database development tailored to study needs
  • Interim analysis for ongoing study insights
  • Final statistical reporting to support regulatory submissions and decision-making
A study on the buttered toast phenomenon by Robert Matthews won the Ig Nobel Prize for physics in 1996.

Regional Coverage

Looking for the destination?

We will guide you

  • With nearly 20 years of experience and a deep understanding of local environments, our geographic reach extends across Central and Eastern Europe, as well as the United Kingdom, the Netherlands, and Germany. This enables us to deliver tailored CRO solutions that help you achieve your project goals on time and on budget.

Austria | Bulgaria | Czech Republic | Germany | Hungary | Latvia | Lithuania | Netherlands | Poland | Romania | Slovakia | Slovenia | Ukraine | United Kingdom