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Clinical Research and Site Management

Fidelis will ensure the success of your trial as a CRO or SMO across a network of clinical research sites in Bulgaria, Croatia, Romania, Serbia and Turkey

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FIDELIS RESEARCH provides all the functions required to plan and execute a successful clinical trial program or individual trials from start to finish.

The company establishes a team for each new project, to facilitate rapid site activation and achieve continuous review and processing of site documents. Country-specific expertise is used to ensure time-saving and efficiency in trial site and patient recruitment and retention.

We recognize that whilst the 'full-service' model is perfect for many of our customers, some sponsors do not require all of them.

For this reason, FIDELIS  is delighted to provide either a full service, separate trial functions, or solely experienced clinical operations staff on demand, dependent on each client's individual needs.

As an SMO FIDELIS RESEARCH recruits patients and conducts clinical trials in a broad network of sites in South East Europe - Bulgaria, Croatia, Romania, Serbia, Turkey. The sites vary and include general hospitals with different type of specialized departments (gastroenterology, cardiology, infectious disease, neurology, endocrinology and others).

The sites we manage are selected after detailed analysis of the clinical trial industry in South East Europe. We have taken into consideration important factors such as: Projects saturation, Investigators motivation, level of equipment, regional distribution of patient groups, access to medical care.

 

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FIDELIS RESEARCH can take over certain activities as an INDEPENDENT CONSULTANT. Executives from the company can act as independent consultants and advisors for clinical trials.

FIDELIS RESEARCH consultancy service offerings are:

  • Study Start up – FIDELIS RESEARCH can work independently and be your advisor when you work either with a global, regional or a local Contract Research Organization. FIDELIS RESEARCH is specialist in Eastern Europe, which is why whenever you receive  start-up scenarios from a CRO, with a set of countries and number of sites, we can advise you which scenario is most suitable for your current clinical trial needs. Thus you will have a second independent point of view, provided by an expert with extensive experience working internationally, and specifically in Eastern Europe.
  • Budget negotiation – FIDELIS RESEARCH Executives can act as your partner and representative throughout the CRO selection process. We can build for you RFIs, RFPs and budgets grids which will precisely outline your clinical trial needs. FIDELIS RESEARCH can also be your advisor during bid defense meetings, and can review and compare Apple-to-Apple CRO budgets and proposals. We read between the lines, in order to make sure that the whole scope of work is precisely outlined, which can subsequently minimize the percentage of change orders and unexpected costs
  • Regulatory Expertise – FIDELIS RESEARCH can be your advisor and oversee regulatory submissions in Eastern Europe, which will significantly speed-up the approval process and shorten the time from Study Start-up through enrollment of the first patient

When providing any of the above consultancy service, FIDELIS RESEARCH will provide you with official reports and a number of recommendations on how you can reduce Service fees, Pass-though costs, and shorten study timelines.

When the sponsor of a clinical trial is not based in the European Economic Area (EEA), for example, an American, Israeli or Japanese company, it is a statutory requirement to appoint a legal representative based in the EEA for the purposes of the trial.

FIDELIS RESEARCH clients which do not have a subsidiary within the EEA, authorize us for the purpose of performing clinical research projects as a representative, known as a “legal representative” for clinical drug trials and “authorized representative” for medical device trials.

Thus they fulfill the obligation that the drug and the medical device companies must be established or represented in the EU.

FIDELIS RESEARCH can represent you as your “legal representative” across the European Union for all your drug and medical device trials to enable submission of your regulatory applications to the European competent authorities and ethics committees.

FIDELIS RESEARCH can offer this service for you and your contracted local CROs who might not be able, or have sufficient experience to provide legal representation services.

With experienced project managers and coordinators on board, FIDELIS RESEARCH guarantees to clients high-quality of deliverables:

  • Centralized Feasibility process
  • Patient recruitment (database review, pre-selection, direct communication with patients)
  • Patient retention and compliance to study protocol (patient education, procedure for patient next visit reminders)
  • Site staff training
  • Coordinated study administration
  • Streamlined budget and agreement negotiation process
  • Essential documents collection and IRB/IEC submission

Why choose FIDELIS RESEARCH's Site Network:

  • Access to large patient population
  • Lack of competitive clinical trials at our site network
  • Fast-track conduct from feasibility through close-out
  • Motivated Principle Investigators
  • Dedicated project coordinators
  • Proven track record

FIDELIS RESEARCH offers project coordiantors on a functional service provision (FSP) basis. Some of the KOLs and Sponsors have chosen us to improve quality of performance, reduce delays in CRF completion and cope with the “data tsunami”.

We do believe that having a project coordinator on site, is an added value and quality to your clinical trial, and is a beneficial supplement to the risk based monitoring approach.

If you are interested in insourcing FIDELIS RESEARCH project coordinator for your clinical trial, we will be glad to hear your needs. Some of our clients have done that already!

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Geographical coverage

Fidelis operates in South Eastern Europe, with staff located in Bulgaria, Croatia, Romania, Serbia, Turkey

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