Service

  • Our key components of good cooperation are:

  • Reliability and confidentiality
  • Trust and confidence in our leadership
  • Efficiency
  • Flexibility
  • Competitiveness
  • Effective communication between Sponsor and CRO so that we can contribute to achieving key business objectives and goals of the sponsor in the best way possible
  • Professional approach: qualified medical staff, experienced and trained monitoring staff
  • Well-established network of clinical sites our CRO cooperates with
  • Good and long-term relations with investigators and Regulatory Authorities
  • Delivery of reliable results in a timely manner
  • Costs effective services in comparison to global CROs

 

Our Services

  • Include:

  • Project management
  • Site Identification / Investigator Recruitment / Feasibility Assessment
  • Study Setup (including site contract management)
  • Regulatory Authority submissions and communication,
  • Multicentric and Local Ethics Committee submissions and communication -obtaining clinical studies approvals,);
  • Regular contact with RA/EC throughout the study
  • Full CRA service for clinical studies of phases I – IV - On-site monitoring (pre-study visits, initiation visits, routine monitoring visits, close-out visits)
  • Site management
  • Site contracts and payments
  • Patient Recruitment
  • Translation and cultural adaptation (PIS/ICF, Protocol and other documentation);
  • Quality Assurance, local SOPs and own quality management service - audit quality support, further training and education of CRAs
  • Investigator meeting arrangements
  • Medical translations
  • Monitoring service for observation studies
  • Collaborating with partner CROs from other European countries
  • Technical support for study-specific systems and devices
  • Transfer of study specific materials to the site (drug accountability and IMP return or local destruction)
  • Training of study staff for the conduct of clinical trial, safety reporting
  • GCP training of sites

 

Our Regulatory

    Affairs of human drugs:

  • National Registration
  • Central, DCP, MRP Registration
  • Variations both Type
  • Renewal of Registration
  • Transfer of Marketing Authorization
  • Translation of essential documents
  • Readability testing of PILs
    • and
  • medical devices
  • diagnostic substances
    • Categorization and Price Assessment of the products
    Assessment of Import Price by Ministry of Finance
    Assessment of Sale Price by General or National Health Insurance

 

Who are We

We are an experienced, mid-size and dynamically growing flexible partner in clinical trials in Central Europe. Our company was established in 1999 by an experienced professional with several years of experience in clinical research. We assist our clients to help them successfully perform clinical trials in Slovakia, the Czech Republic, alternatively Austria and Hungary. All studies are conducted by a monitoring team of highly qualified professionals with medical, pharmaceutical or natural science background.


 

Know more..

OUR STAFF

Our professionals have previously worked in small, medium and large pharmaceutical companies, in full service CROs and at investigational sites. This gives us a very good understanding of the industry and allows us to listen closely to our clients in order to develop a unique approach, tailored to their specific needs.

 

We cover monitoring services at all levels, local and regional, via the following positions : Clinical trial Assistants/Coordinators , Clinical trial Monitors, Regional Clinical Trials Assistants, Regional Clinical Project manager. Our Clinical Research Associates (CRAs) are one of the strongest links in the chain and act as the main line of communication between investigators and your departments. The average experience of our monitors in clinical trial monitoring is 7,5 years.

In Central European Countries: Slovakia, the Czech Republic, Austria, Hungary sponsors of clinical trials can find highly motivated and educated professionals, who can offer to pharmaceutical companies their time, knowledge and experience for very reasonable value. Moreover these countries have relatively short regulatory and ethics committee timelines.

We are able to identify and contract investigators for clinical trials for Phase I to Phase IV studies, organize investigator meetings, perform study setup and monitoring. Local knowledge is our strong advantage, which allows us to select the best recruiting investigators, shorten study timelines and obtain high-quality data. In addition, in Central European countries, sponsors can find large database of patients with different indications willing to participate in clinical trials, not affected by restricted therapies or other exclusion criteria.

Clinical areas of expertise: cardiology, neurology, psychiatry, oncology, ophthalmology, gastroenterology, endocrinology and diabethology, rheumatology, pneumology, infectious diseases, urology, orthopedics, etc.

To meet any client needs, we can introduce additional services provided either by our resources or by our partners, upon request.

Our activities are strictly based on ICH-GCP guidelines, new EU directives, local legislation and ethical principles.

We have undergone successfully several sponsor audits, inspection by RA in Slovakia and FDA inspection in 2009.

Our Therapeutic Clinical Research Experience

Cardiovascular - Endocrinology and Metabolic - Hematology and Oncology - Infectious Diseases - Respiratory - Urology - General Medicine Clinical Research - Gastrointestinal - Orthopedics - Central Nervous System (CNS) Clinical Research Experience - Psychiatry - Neurology

 

Contact us

Contact Info

Styles trade P.A. s.r.o.
Senecká 114, 900 24 Veľký Biel
Slovakia

E-Mail: angelika.schmiedlova@stylestrade.sk


Tel: +421 0915 162 017