Our team of experts, as well as our proven track record in the region of Southeastern Europe, make us a trusted partner in the field of Clinical Trials.
Clinical trial services
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Europe as a whole is experiencing rapid changes and advancements in the field of clinical trials. In our region of Southeastern Europe, many nations have decades of experience with the handling and operation of clinical trials, as well as the region being home to countless globally recognized opinion leaders in clinical research.
However, succeeding in this region is far from easy. The impact of different cultural attitudes, customs, languages, and systems of communication must not be underestimated when planning a multinational trial.
Southeastern European countries (SEE), which include Croatia, Serbia, North Macedonia, Bosnia and Herzegovina, Bulgaria, Slovenia, and Romania are nations where large numbers of patients naïve to treatments can still be found. These countries have GCP integrated into their laws and regulations, as well as investigators with high quality performance records and general motivation for participation in clinical trials.
Sponsor companies often look to these regions in order to help achieve patient recruitment in predefined plans and reduce overall expenditures.
Breakdown of studies per therapeutic area
Legal Representation services were launched within Clinres farmacija in order to meet the legislative requirements of clients who do not have a subsidiary company within the European Union, for the purpose of performing clinical research projects in the European Union.
Such a representative, known as a “legal representative” for clinical medication trials and “authorized representative” for medical device trials, fulfils the obligations stipulated in the Regulation (EU) no. 536/2014 of the European Parliament and of the Council from 16th of April 2014 on clinical trials of medicinal products for human use.
Clinres farmacija can represent drug and medical device companies as a “legal representative” in all member states of the European Union for all drug and medical device trials and thus enable the submission of regulatory applications to the European authorities and ethics committees.
The key to high-quality data management is flexibility. We work collaboratively with our clients to find an optimal solution to data management needs. We believe it is ideal to integrate data management and the study team right from the start in order to achieve efficient and timely data cleaning.
Our services include:
- CRF design and development, system implementation and trainings on (e)CRFs
- Data management Plan development and implementation with full project management and oversight
Our stand-alone system provides services and data management throughout an entire clinical trial.
Every successful clinical trial has effective clinical data management (CDM) at the core. At Clinres farmacija, we have made the collection and handling of clinical trial data a central part of our entire services.
Clinres farmacija can provide statistical services in wide range of therapeutic areas and support clients in their needs. As clinical trials and regulations become more complex, it is important to work with a biostatistician who understands the current regulatory environment.
Clinres farmacija provides the following clinical biostatistics services:
- Statistical Plan development and Statistical programming
- Statistical reporting
- Bioequivalence study statistical analysis
Clinres farmacija has an exclusive agreement with well known, experienced and reliable partner Site Management Organization. Together we share a network of experienced sites providing them education, support and management throughout all phases of clinical trials focusing on patient recruitment and retention, site expeditiousness and reliability.
A formal feasibility study prior to study launch can prevent many patient recruitment challenges from becoming a significant hurdle. Clinres farmacija has been recognized by all our clients as providing accurate, insightful, and comprehensive Protocol and Country Feasibility Assessments.
We take pride in maintaining the highest possible standards. Our assessments are used as a basis for our recommendations on protocol design, operational execution, and country set-up for the study.
During the Feasibility Assessment process, we select investigators who best match the needs of the project and protocol, as we are diligent about maintaining long-term relationships with investigators in private or group practice, as well as academic medical centers. Our extensive and proprietary database of experienced medical professionals helps us quickly identify the right investigators to handle clinical trials. We also use commercial investigator databases, relevant health care organizations, previous site experience, and client recommendations.
Clinres farmacija’s long-term partnership with sites ensures close monitoring and support throughout the trial. We also enhance site participation by provide ongoing training.
Feasibility data collected during the assessment process is analyzed, summarized, and graphically presented in a Feasibility Assessment Summary document which clearly provides supporting data and facts to assist clients in the optimal development of clinical research programs. Based on the results of the survey, Clinres farmacija provides information, data-driven suggestions, and recommendations in relation to those countries and the number of patients selected.
Our practice is to conduct blind feasibility assessments, hence details about the client or the product which is being investigated is not revealed to the contacted investigation sites. Therefore, a confidentiality agreement with sites is not required, expediting the initial stage of the process.
All questions from sites and Clinres farmacija experts during the feasibility assessment process are collected and included in the Feasibility Assessment Summary.
Clinres farmacija has extensive experience in activating investigation sites within a short period of time. Usual activities during the site activation process include the gathering of essential documents from sites and contract negotiations with hospitals and investigators.
Clinres farmacija can either use our site-specific contract templates or work with templates provided by the client. The advantage of using our own contract templates is that the review will be more streamlined and will shorten the time from contract signing to clinical trial approval. Our experts will assist in drafting target budgets which control costs, all the while ensuring equitable compensation. Moreover, we draft alternative language and budget parameters which serve as additional incentives for investigators’’ and their involvement in the clinical trial.
We develop site budgets based on the study protocol and client approval. Working together with the project management team, we facilitate timely payments to investigators and organizations while delivering comprehensive and high-quality customer service to both clients and investigators. Our Investigator Grant database comprehensively tracks payments based on procedures performed, patient visits completed, milestone payments, and other measures. A grant payment summary is provided with each site payment.
Essential Documents Collection
Clinres farmacija has built strong relationships with many sites, helping us collect site-specific documents for submission to the Competent Authority and Ethics Committee in a timely manner.
At Clinres farmacija, our extensive experience in conducting clinical trials, highly trained CRAs, as well as thorough knowledge of local regulations and GCPs collectively allow us to guarantee effective and efficient management of investigator sites.
Our Clinical Research associates perform all types of visits, reviews of regulatory documents, investigator training, assistance in resolution of queries, and preparation of Corrective and Preventive Action Plans.
Clinres farmacija believes that professional clinical research associates form the backbone of any successful research study. At Clinres farmacija, our dedicated team of CRAs — all with diverse clinical backgrounds, including MDs, RNs, scientists, and clinical specialists.
Clinres farmacija has a successful record of low staff turnover, which improves the clinical monitoring process throughout the clinical trial span and leads to further improvements in Clinres farmacija’s relationship with investigators.
As part of our commitment to high quality monitoring services, we provide our CRAs with comprehensive training and professional development programs, all to ensure compliance with applicable laws, regulations, and guidelines around the world.
Clinres farmacija’s CRAs are office-based to maximize study management quality, improve, and personalize communication between different departments, as well as allowing teams to embrace the clinical trials as their own.
Our experience in conducting clinical trials has proven best practices and trial metrics which allow us to efficiently and effectively monitor site operations.
Our site management strategy is to maintain constant contact with the sites and to be their trusted partners. We ensure preemption of issues, thus minimizing the risks of mistakes during the trial operation, while at the same time gathering valuable feedback, often of great value to our clients.
Our clinical document translations are both medically precise and culturally sensitive.
Clinres farmacija conducts clinical trials on behalf of pharmaceutical, biotechnology, and other life science companies. The challenge and opportunity of obtaining data from patients with diverse national and cultural backgrounds demands an accurate translation of study documents – a practice we value and strongly adhere to.
Accurate and clear communication between clients, investigators, and patients are imperative for obtaining informed consent, but also building trustworthy relationships with patients, overall improving both patient compliance and retention.
In addition to translation, we also provide linguistic validation of Patient Reported Outcomes (PRO), patient questionnaires used as clinical instruments, and scales in the conduct of clinical trials of new medications. Oftentimes clients require us to perform back translations and reconciliations, cognitive debriefings, and harmonization of the patient responses so that the data is accurate and consistent across multiple languages. It is crucial to have appropriate data for actual data analyses. Faulty or inaccurate translations can render the trial inadequate, thus leading to loss of time and potential revenue for the pharmaceutical company.
Competent project management of clinical trials is one of the most important factors for the successful start-up, conduct, and completion of trials.
Based on client-specific research requirements, Clinres farmacija assigns an experienced project manager to ensure a consistent contact point for the sponsor regarding all trial-related questions. Assigned project manager is responsible for supervision of all activities of clinical operations team members in all participating countries. It involves planning, organizing, and directing the activities of personnel involved in clinical research projects to make sure that they are in line with general clinical goals and objectives. Duties also include monitor and report on the progress of delegated clinical trials, which includes budgets and timelines.
The manager is in charge of the management of all aspects of clinical trial and the selection of vendors to guarantee the safety of patients, non-breaching of contract, procedures, and data integrity. With 10+ years in the industry and excellent knowledge of local legislation in all countries Clinres farmacija is present, our project managers provide high quality performance and guarantee successful conduct of different phases and therapeutic areas clinical trials.
The regulatory framework for performing clinical trials in Southeastern Europe is complex and varies from country to country.
After a project is awarded, the Clinical Trial Application process is executed by a dedicated team, comprising people with many years of experience gained working or studying in major pharmaceutical firms, academia, and clinical research institutions. The team consists of a regulatory expert, project manager, and clinical trial assistant, contracting and legal experts, all dedicated solely to getting the study up and running as efficiently as possible.
Our combined experience covers all major therapeutic areas of research and development. The regulatory team will understand and interpret the regulatory environment and offer different submission scenarios, thus speeding up the overall study timelines.
Clinres farmacija is always informed about the latest European Union Clinical Trial directives as well as local changes in the regulatory frame on clinical trials.
Services we offer include:
- Submissions to regulatory bodies
- Organization of study supply logistics including import and export licenses, with vendor selection and contracting
- Organizing local insurance coverage
- Site contracting
Case Report Form
The Case Report Form (CRF) is the central tool used in clinical trials. CRF captures all the necessary data for each patient during a clinical trial. Clinres farmacija’s CRF design team understands that quality work in the beginning stages is crucial to avoiding expensive re-work and the compromise of data validity.
Our experts design CRFs and eCRFs for every phase of the clinical trial in numerous therapeutic areas. Clinres farmacija preserves a strong, cross-functional relationship between the CRF design team, Clinical, Medical, Data Management, and Biostatistics teams.
The Data Services Printing Solutions offered to our clients include the selection of paper, style of tab formatting, binder selection, and various graphics.
At Clinres farmacija we can provide medical writing services aligned with biostatistics requirements. Medical writers provide support to our clients at all stages of the medication development process.
Our service is focused on providing well-crafted interpretations of bio-statistical output. Services range from drafting study reports, patient narratives, regulatory submissions, manuscripts, protocols, newsletters, posters, preparation of study reports.
Medical writers possess both significant scientific strength and substantial international writing and regulatory experience.
Study medications must be manufactured, stored, and distributed in strict accordance with Good Manufacturing Practices and Good Distribution Practices, utilizing labelling and packaging which matches the trial protocol.
Through local dedicated warehouses, Clinres farmacija can provide timely and cost-effective delivery of a client’s study medications and medical devices to any country where we operate.
When allowed by local regulation the client has the ability to ship investigatory medicinal products directly to the sites, the process that is much more cost effective and faster.
At our dedicated warehouses we offer both ambient and temperature-controlled (2 – 8 ºC) logistics, including monitoring temperature during transit. At the end of the trial, we retrieve and reconcile unused medications and devices and complete all necessary steps for their destruction.
Through Clinres farmacija’s streamlined IMP storage and supply processes, led by assigned and designated specialists, we have the experience and expertise to make sure the client’s study medication is always available where and when necessary. Years of experience enable us to import study medications quickly, handling them properly, and reducing the risk of oversupply and expiry.
Clinres farmacija offers its clients an integrated solution for a full range of staffing needs, from providing skilled individuals or teams on a temporary basis, to managing entire functions or departments on client’s behalf.
Clinres farmacija’s Functional Service Provision (FSP) models can provide staffing solutions in different phases for your clinical research programs:
- Study start-up
- Clinical trial applications
- Clinical Research Associates
- Project management
- Medical writing
Clinres farmacija has been implementing and managing flexible staffing arrangements for some of the ten largest pharmaceutical and biotechnology companies since 2004. Clinres farmacija’s governance team reviews performance metrics and regularly meets to ensure the consistent delivery of services. Reports covering the full range of operations are provided to upper management on a monthly basis.
Clinres farmacija offers two main models of FSP:
- Ad-hoc staff provision
To fill an unexpected gap or to facilitate rapid scale-up of client workflow, and to provide staff for a week, a year, or more.
- Functional Service Provision
When outsourcing entire job functions to Clinres farmacija, we help the client develop a team with precisely the kind of qualifications necessary to handle a single function across several programs, a range of functions within a single therapeutic area, or any or all parts of your clinical study needs.
Our Functional Services were created to provide flexibility to customers who are interested in outsourcing particular functions rather than full clinical research programs.