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Clinical Trial Services

We provide all services for conduct of successful clinical trial program or individual trial in Eastern Europe.

Feasibility Studies

DELAYS in study startup and patient enrollment are the major contributors to cost overrun in clinical trials.
 
FIDELIS RESEARCH believes that realistic assessment of country and site level feasibility is critical to trial success and must be implemented early in trial planning. Without detailed and accurate feasibility data on which to base country and site selection, a reliable prediction of enrolment rate and therefore successful planning of trial deliverables is impossible.
 
A properly designed and executed feasibility study can provide comprehensive assessment of a clinical trial’s specific challenges as well as strategies to mitigate risks before startup activities begin. Companies that run full feasibility studies experience faster clinical trial accrual and significantly fewer delays in enrollment than those that miss that assessment.
 
A properly conducted clinical trial feasibility study can provide information regarding:
 

  • Sites – Interest in clinical Trial, Experience, Standard of Care, Equipment and capabilities
  • Patients – Enrollment potential, willingness to participate
  • Regulatory – Requirements and timelines, Local IECs
  • Logistics – Import Licenses, Drug handling and destruction
  • Potential risks related to study design and strategy

FIDELIS RESEARCH works directly with clients to design a feasibility study that is appropriately tailored to the needs of the planned clinical trial or program.
 
CONDUCTING THE FEASIBILITY STUDY
 
Feasibility studies at FIDELIS RESEARCH are conducted by dedicated feasibility team, which is construed of personnel with similar therapeutic experience and has well established relations with Investigators.

CUSTOMIZED FEASIBILITY REPORT

As final deliverable, FIDELIS RESEARCH provides a complete feasibility report, signed confidentiality agreements and completed feasibility questionnaires that directly and comprehensively address the specific information requirements of the planned trial or program.
 
Moreover, after each feasibility study, FIDELIS RESEARCH proposes several justified and interrelated study strategies from which our clients can finally choose.
 
FIDELIS RESEARCH uses its own format for the feasibility report which can be customized to clients’ needs and requirements.

Study Start-Up

Important condition to success of any clinical trial is appropriate site selection and study Start-up. FIDELIS RESEARCH has close relation to large number of high quality, motivated investigational sites with high recruitment potential.
 
Formal feasibility prior to study launch can prevent many patient recruitment challenges from becoming a potentially major hurdle. Our experts can help plan from the very beginning with a carefully conducted feasibility evaluation of the protocol. If we are not involved in a formal assessment, we will still perform review.
 
During Start-up, FIDELIS RESEARCH runs multiple-angle analysis and assesses:

  • Investigators who best match the needs of the project and protocol as we carefully maintain our long-term relationships with investigators in private or group practice and academic medical centersCreate strong partnerships with sites to provide close monitoring and support, as well as ongoing training to enhance site participation
  • Create risk management plan that includes enrollment contingency planning with risk identification, probability, impact, triggers and mitigation strategies because even best patient recruitment strategy can sometimes run into difficulties

  • Contract negotiation process

  • Protocol design risks – Such as trial design, study IMP, availability of placebo and its ethical aspects

Provided that FIDELIS RESEARCH has certain reserves related to study design or documents, we will perform the necessary meeting with all stakeholders (Hospital Directors, Local Ethics Committees, and Competent Authorities) in order to facilitate smooth start-up and regulatory process.

Clinical Monitoring

 
FIDELIS RESEARCH’s clinical monitors are chosen for their educational background, English language fluency and their problem solving skills.
 
FIDELIS RESEARCH offers a nice blend of experience and youth. For the majority of our trials we allocate monitors with extensive experience in clinical research and the appropriate therapeutic area, accompanied by inexperienced monitors who are overseen and trained throughout the study course.
 
FIDELIS RESEARCH monitors perform all activities related to pre-trial/qualification visits, initiation visits, interim monitoring visits and close-out visits, ensuring compliance to the protocol and all regulatory requirements. They also maintain strong and constructive relationships with investigative sites to ensure successful trial progress.
 
In addition to our full service offering, FIDELIS RESEARCH also provides teams of monitors to work under the Sponsor's project management.
 
PROFESSIONAL EXPERIENCE

All experienced FIDELIS RESEARCH CRAs have effectively monitored biopharmaceutical and medical device studies across all phases of product development and ensure ICH/GCP compliance and data integrity at each site visit. FIDELIS RESEARCH CRAs are main players in clients’ clinical trials.
 
ONGOING TRAINING

As part of our commitment to quality monitoring services, we provide our CRAs with comprehensive training and professional development program to help ensure compliance with applicable laws, regulations and guidelines around the region.

Project Management

The assigned project team to each trial is selected according to each Sponsor's needs. FIDELIS RESEARCH takes personnel training as the most important prerequisite for successful conduct of a clinical trial.
 
The team's extensive knowledge is refined with trial and sponsor specific training where needed, FIDELIS RESEARCH understanding for high quality is not only extensive knowledge of English language, computer skills, knowledge of all applicable standards for clinical trial conduct, but we also make a step forward towards development of team’s soft skills and problem solving attitude.
 
Low staff turnover ensures that Project Team members typically remain constant throughout the duration of a trial and the organizational structure allows direct communication with all levels of management and rapid response times. FIDELIS RESEARCH teams are characterized by their pro-active approach, expertise, seniority, competence, leadership, flexibility and their rapid problem solving capabilities.
 
FIDELIS RESEARCH's Project Managers have experience and discipline needed for the successful creation and management of the Project Plan, tracking, follow-up and communication of project status and issues.
 
Project Management assures, project planning, tracking and reporting, overall project supervision, regular one on one meetings with clients and team members, budget knowledge and management.
 
FIDELIS RESEARCH Project Managers are responsible for preparation of project status updates, providing our clients with general overview of project milestones and deliverables.

 

Site Management

FIDELIS RESEARCH believes that efficient site management is fundamental to the success of a clinical trial, and is crucial to having valid, credible data entered and analyzed.
 
Our monitors strive to develop a strong working relationship with each site we work with, and to ensure proper conduct of the trial in accordance with applicable laws and regulations.

Through ongoing site management, FIDELIS RESEARCH ensures vital link between CRA, Project management, Sponsor and the site. It provides full site support in all aspect of a clinical trial from study start-up to close-out.

Site management encompasses a range of activities, including assessment of enrollment, investigational product accountability, proper electronic and paper based CRF completion, timely scheduling of patient visits, continuing protocol adherence, reporting of SAEs, and investigation and resolution of outstanding queries.

Vendor Management

Whenever you need local management of vendors and suppliers, we can help you select the best one for your specific need. FIDELIS RESEARCH also provides close cost control on all tasks and expenses for the different type of vendors and suppliers.
 
FIDELIS RESEARCH uses the following type of local vendors:
 
INSURANCE COMPANIES
 
In some countries local insurance may be needed. FIDELIS RESEARCH performs all activities related to obtaining insurance policies:

  • Insurance of the patients participating in the research
  • Insurance of investigators
  • Insurance of the medications under research during their transportation to the country of research

Insurance of the medications during their storage in clinics or at a centralized warehouse
 
DRUG PACKAGIN AND LABELLING
 
In collaboration with our partner, FIDELIS RESEARCH takes care of any requirement to package and label, store and distribute investigational products and can also arrange for subsequent destruction of unused product at the end of the trial.
 
FIDELIS RESEARCH supervises all of these activities depending on specific need, acting as point of contact for both the centers and the Sponsor, providing real-time resolution of issues.
 
CUSTOMS CLEARANCE OF STUDY MEDICATION AND STUDY MATERIALS
 
Importing and exporting materials can be time consuming and complicated if you don’t know or understand the processes.Our management group works with our vendors to ensure sites have what they need when they need it. They know the paperwork, they know who to call if something gets tricky. 

PURCHASE OF EQUIPMENT AND COMPARATOR DRUGS
 
FIDELIS RESEARCH has preferred providers for delivery of medical equipment and comparators drugs.
 
TRANSLATION SERVICES
 
Following the local regulations and requirements translation into local language is a must. FIDELIS RESEARCH partners provide translation of the following documents:

  • ICFs
  • Protocol Synopsis
  • QOL
  • CT reports
  • IMP labels

Contract and Budget Negotiation

Contract and budget negotiation is one of the key milestones for the timely start up of a clinical trial in Eastern Europe. In addition to that for Bulgaria and Romania, executed contracts are required as part of the clinical trial application
 
As a standard practice separate contract will be signed with the institution and the Principle Investigator.
 
FIDELIS RESEARCH has its own developed contract templates pursuant to the local laws and hospital requirements. Our templates will be used after their review and approval from Sponsor.
 
FIDELIS RESEARCH team will assist with drafting reasonable target budgets that control costs, we also envisage certain stoppers in order to assure sites’ commitment throughout the whole study. We also work with you to draft alternative language and budget parameters in anticipation of negotiation based on our extensive experience.
 
By anticipating requests for changes and creating alternatives in advance, we can rapidly negotiate your clinical study agreements, expediting your trial initiation and work throughout the trial to make any necessary changes.