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Set your Clinical Trial for Success

Clinical Research Services

clinical trial in eastern europe

We are committed to supporting you in delivering the new solutions for improving and sustaining health to the market

HYGEIA Research is providing clinical research services for Phase II through Phase IV clinical trials in Belarus, Bulgaria, Croatia, Georgia, Hungary, Kazakhstan, Moldova, Montenegro, Poland, Romania, Russia, Serbia, Turkey, Ukraine and Uzbekistan.

Mindful that any of us could be a patient using the drug we helped to be brought on the market, we approach every step of our job with high ethical standards. We believe that the quality of our work is a must. We also believe that quality can be delivered only by the people who are properly educated, trained, and who have the appropriate experience.

SERVICES

Site Management

HYGEIA Research’s site management strategy is to maintain open, proactive communication with sites and to be their trusted partner. Our CRAs are available to sites; sites can contact them any time in case they need any support, advice or assistance while working on your clinical trial. In our experience, this approach minimizes the risks and is enabling efficient and effective clinical trial conduct.

Experienced CRAs

An important part of our “setting trial to success” philosophy, is our commitment to work only with experienced, appropriately trained CRAs who are capable of ensuring that quality data is consistently delivered. Knowing that behind every monitored page there is a life of a real patient, our CRAs approach each monitoring with a deep understanding of the disease, treatment and protocol requirements, always keeping in mind GCP standards.

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 Our monitors are medical doctors or have similar backgrounds and come with significant experience in clinical research. They are dedicated to delivering the highest standard of excellence in their work.

At HYGEIA Research we understand that only commitment to work can have high quality results as an outcome; this is why our CRAs are organized in a way to have time to be fully devoted to your clinical trial, instead of working on multiple parallel projects at the expense of data quality.

Our CRAs are native speakers of the local languages and are as well fluent in English. Due to their professional background and experience, they have an on-going professional relationship with the leading local investigators and sites.

      CRA Capabilities include:

  • Essential document collection and maintenance
  • Ethics Committee and regulatory review board submissions
  • Site contracting, budget negotiation, and grant administration
  • Site qualification, initiation and closeout
  • Interim site monitoring
  • On site staff trainings (ICH-GCP, protocol and other clinical research topics)
  • Corrective Action Preventive Action (CAPA) implementation
  • Drug accountability
  • Data query resolution

Regulatory and Start-up Services

Taking new products successfully through clinical development, submission, and approval can be a difficult, expensive and lengthy process. This process is complex and varies from country to country. HYGEIA Research can help guide you throughout the full continuum of clinical development an provide you with all the local regulatory expertise to ensure the smoothest possible start to your study in the countries we are operating in.

Recognizing that time in clinical research is sacred, our specialized “start-up” teams are assigned to your study shortly after a project is awarded. They work with sites on performing pre-screening of patients whenever the indication allows and can conduct feasibility and site identification in parallel with essential document collection and submissions, thus ensuring the fastest start-up possible as well as having the First Patient In (FPI) shortly after the Site Initiation Visit (SIV).

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Regulatory and Start–up Services Include:

  • Translation of all study-related documents into local languages
  • Submissions to regulatory bodies
  • Site selection and qualification
  • Organization of study supply logistics, including obtaining import and export licenses
  • Organizing local insurance coverage
  • Site and investigator contracting
  • Organization of legal representation

HYGEIA Research can provide these regulatory and start-up services as “standalone” services if required. Please contact office@hygeiaresearch.com for more information.

Project Management

Our philosophy is to become an extension of our client’s’ team to facilitate seamless study conduct and communication. To achieve this goal, our project managers are selected due to their experience and proven record of accomplishment in quality and delivery. Our managers have the right expertise, an enthusiastic “can do” flexible approach to deliver on time and within the study budget.

All Project Managers and all other staff are fluent in English as well their local language.

We want to ensure that the resources we assign to each project are with you for the entire duration of the study, and in most cases do not assign a Project Manager to more than one project at any one time.

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Our Project Management approach is based on an ongoing anticipation and management of issues and offering proactive solutions. We are very flexible in structuring a highly collaborative relationship with clients in order to achieve the best results, creating efficiencies and keeping the client informed and in control of the project.

Medical Guidance

Increasingly complex drug development demands support from medical experts to navigate the challenges. AT HYGEIA Research we can provide you with expert advice at all stages of product development, as well as medical monitoring and medical safety oversight. Our experienced medical experts provide early and ongoing insight and guidance throughout the project lifecycle.

We can support your study by providing strategic medical advice in the following ways:

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Consultancy

  • Protocol development and study design consultation
  • Contribution to clinical trial documents
  • Investigational product assessment
  • Target disease assessment
  • Individual patients’ characteristics
  • Medical support in CRF design
  • Medical liaison with Key Opinion Leaders, investigators, authorities
  • 24/7 medical information support on protocol, compound and safety issues
  • Trial-related medical data review
  • Medical guidance/training to study teams and sites

      Diagnostic Remote Radiology Readings

Our radiology experts can provide you with remote diagnostic radiology readings using digital imaging equipment and RECIST 1.1 criteria.

    • CT (abdomen, pelvis, head, neck, chest, facial bones, spine, temporal bones, upper or lower extremity)
    • MRI (abdomen, pelvis, chest, head, brain, prostate, spine)
    • MR Angiography (MRA)

HYGEIA Research can provide any of these medical services as “standalone” services if required. Please contact office@hygeiaresearch.com for more information.

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