Vidox Consulting S.A.
We know how to make CRO business in Russia, Poland, Czech Republic, Hungary and all over Central and Eastern Europe!
Headquartered in Luxembourg Vidox Consulting conducts research, staffing, QA and consulting services throughout the Eastern European & Russian capitals, cities and rural areas.
Our key people are looking back on more than ten years of experience in international clinical research, demonstrating results in management and scientific oversight of international gastroenterology, CVS, internal medicine, CNS, infectious disease, rheumatology, dermatology, oncology and pediatric clinical tests.
Opening the East European market for clinical research 10 years ago and making Russia a most profitable EU franchise, Vidox Consulting’ people demonstrated ability to achieve successful international phase I – IV clinical trials and consulting business expansion through adoption to the Eastern European needs and cultures.
Why in C&EE? The advantage lies in the proven valuable patient recruitment in clinical trials in front of local and international regulatory bodies, the high quality of the data within agreed timeline and the low costs and less competitive trials, compared to western countries.
How we help
Vidox Consulting will provide CUSTOMER with:
Local Knowledge: Up to date and detailed knowledge of the regulatory environment (Ethics Committee and Regulatory Authority procedures and requirements) in Region.
- Physicians Network: In addition to its immediate infrastructure Vidox uses local Scientific Bodies as an extended base covering resources from basic scientific laboratories, to thousand bed clinical research hospitals and centres.
- Access to Patients Patient referral network, recruitment strategy. We assist our customers in recruiting patients to participate in clinical trials through investigator relationships, media advertising, use of web-based techniques and other methods.
- Access to Consumers Potential consumers of health products are patients and healthy visitors of our Investigators and clinical sites. Thousands of them may be targeted just in CEE capitals.
- Project Resource: Availability of a highly trained and motivated team of medics, experts and industry professionals with previous experience in the area.
- Web based technology: Extended user-proven internet technology allows targeting healthcare professionals and their patients around a Region.
The project team is confident in its ability to provide CUSTOMER with the best possible support in running the study in Russia through an experienced team.
We provide a full range of consulting services focused on helping our customers achieve regulatory success, from strategic planning and preclinical services to regulatory submission and approval.
VIDOX team have:
- market expertise;
- medical & scientific training;
- local knowledge;
- depth of service;
- Eastern European capability.
Understanding of Local Culture
Patients in Eastern Europe sign PIC easier for different reasons:
- Because they trust to the doctor (relationship between the investigator and the patient is in Russia and Ukraine and generally in CEE less formal and more personal than in WE). Doctors in CEE spend more time talking to patients than in WE.
- Because they know that international Pharma offers eventually new possibilities for they disease which they otherwise eventually would not have
- Because they do not need to buy the medication and pay for examinations
- Because they get best possible medical care and best possible medical centers in their country
What we do
Company is uniquely positioned to provide lowest cost services to biotechnology and pharmaceutical companies in Eastern European countries, Russia and CIS.
Vidox is experienced in biologicals, medical devices, and small drugs across a wide range of indications, maintaining equal balance between Pilot, Phase I/BE, and Phase II-IV studies.
Applying these capabilities, we are able to significantly expand and accelerate the development of its clients’ therapeutics pipelines.
Service Offerings in C&EE
- Regulatory Strategy
- Regulatory Agency Liaison
- Clinical services
– Clinical monitoring
– Project management
– Regulatory Submission
– Warehousing facilities for drug storage (including cold storage) and
– Distribution in Russia and Ukraine
– Study site coordinators (trial nurses)
- Clinical trial support
– Organizing and delivering investigators meeting in English or in local language
- – Translation of documents (Protocol, Drug labels, Patient informed consent, Patient diaries
- – Drug and tissue samples Import/export license
- – Investigator and hospital payment negotiation and administration
Clinical compliance services include audit service for Investigator sites as per protocol, SOPs, ICH-GCP and other regulatory requirements
– Professional training services, including ICH GCP training for investigators in English or in local language
- Marketing Research and Consulting
– Independent Feasibility Studies
– Clinical study assessment
– Identification of clinical sites and investigators’ recruitment
– Medical support and consultancy
– Preparation and organization of investigator meetings
– Medical writing (including protocols)
– CRF set-up and review
– Preparation/review of Patient Information Sheets and Informed Consent Forms
– Regulatory consultancy and preparation of regulatory dossiers
– Clinical trial agreements: preparation and administration
– Data management and biostatistics
Vidox provides Customer & activity-based dedicated resources
Vidox responsible for management and training of its FTEs
Vidox FTEs may use Customer systems, SOPs and processes