Vidox Consulting S.A.

VIDOX  committed to deliver exclusive, industry oriented events. Whether your event hosts a few hundred or thousands of attendees, our complete team delivers excellence!

Through VIDOX’ unique online educational platform we’ll help you identify and develop the best content, comply with industry support, and take charge of implementation. With vast market expertise and experience in educational design, entrust your content with the education experts.

VIDOX facilitates the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery

Headquartered in Luxembourg Vidox Consulting conducts research, staffing, QA and consulting services throughout modern capitals, cities or 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 emergin markets for clinical research 20 years ago Vidox Consulting’ people demonstrated ability to achieve successful international phase I – IV clinical trials and consulting business expansion through adoption to local needs and cultures.

Why emerging markets? 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 project in emerging market 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

 

What we do

Company is uniquely positioned to provide lowest cost services to biotechnology and pharmaceutical companies in emerging markets

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
– 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
    • Audit

Clinical compliance services include audit service for Investigator sites as per protocol, SOPs, ICH-GCP and other regulatory requirements

    • Training

– 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

VIDOX will provide your project with the following legal support


•    Strong organizational, planning, project management, communication, presentation and influence skills.
•    Strong business acumen.
•    Solid understanding of the government regulations that affect the operation of the organization
•    Good knowledge of SaaS/technology licensing models and principles
•    Ability to work creatively in a fast-paced environment
•    Sound decision-making skills
•    Exceptional attention to detail and ability to work simultaneously on multiple priorities
•    Ability to work independently, establish and maintain effective working relationships with coworkers, managers and clients, and at the same time be a good team player
•    Possess excellent interpersonal and relationship building skills necessary to quickly establish credibility and trust throughout the organization.
•    Ability to deliver results and handle confidential information.

 

VIDOX frequently works with clinical trial sponsors on clinical trial contracting and compliance. We assist clients in their contractual needs of their pre to post-market research endeavors, including observational studies, registries, interventional clinical trials, and investigator-initiated research. We also help clients understand their regulatory requirements for being a sponsor of an FDA-regulated clinical trial.

ROUTINE ASSIGNMENTS INCLUDE

VIDOX provide a wide array of Pre-Clinical/Clinical services

CLINICAL TRIAL AGREEMENTS

Clinical trial agreements (CTAs) and other research-related agreements – We prepare and negotiate agreements related to the conduct of clinical trials, including CTAs, investigator agreements, investigator-initiated research grants, confidentiality agreements, hospital use agreements, and research consulting agreements.

INFORMED CONSENTS

Informed consents – We prepare and negotiate informed consent documents to be internationally compliant, as well as to maintain consistency with the protocol and CTA.

 

GCP AND RELATED COMPLIANCE

VIDOX provides guidance on the laws and regulations for sponsors of clinical trials, including consenting, monitoring, documentation, financial disclosure, subject data privacy, and HIPAA.

CONTRACT RESEARCH ORGANIZATION (CRO) ASSISTANCE

VIDOX is a resource for legal services and counsel to CROs conducting clinical trials on behalf of sponsors.

 

Our Contract Negotiators team supports our clients. We handle an extensive portfolio of projects primarily related to Research & Development Solutions and clinical offerings. 

 

VIDOX services include:
•    Reviewing, drafting and negotiating a broad range of industry related documents with VIDOX’s customers.
•    Ensuring that contracts are in compliance with legal, regulatory and organization policies.
•    Monitoring the contract process to assure compliance with the organization’s contractual guidelines, satisfaction of customers, including participation in pre-contract discussions, contract negotiations and contract changes.
•    Participate in the development of departmental procedures to improve the timely completion of contract deliverables.
•    Track work and obtain appropriate reviews and approvals, adhering to established processes.
•    Ensure delivery of a final contract in a timely fashion, working independently or as part of a team.
•    Develop and deliver training to “upskill” non legal staff
•    Attend and participate in team meetings.
•    Coordinate legal matters handled by outside counsel.