Clinical Trial Services
Clinical Trial Services
Tjaša Rakovec, Bsc Biol
Our team of experts and proven track record in the Region of South Eastern Europe make us a trusted partner in the field of Clinical Trials.
Today, Europe is undergoing rapid changes in the field of clinical research. South-Eastern European countries already have decades of experience and are home to many well-known and globally recognized opinion leaders in clinical research.
South-Eastern European countries (SEE) such as Croatia, Serbia, Macedonia, Bosnia and Herzegovina, Bulgaria, Slovenia and Romania are areas where high numbers of treatment naïve patients can still be found. These countries have GCP implemented in their laws and regulations, as well as investigators with high quality performance and motivation for participation in clinical trials.
Sponsor companies often look to these regions in order to help them achieve patient recruitment in predefined plans and reduce overall expenditures.
However, succeeding in these regions 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.
Legal Representation services were introduced within Clinres Farmacija in order to meet the legal 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, and repealing Directive 2001/20/EC.
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 to enable the submission of regulatory applications to the European authorities and ethics committees.
The key to high-quality data management is flexibility. We work hand in hand with you to find an optimal solution to your data management needs. We believe that it is ideal to integrate data management with the study team right from the start in order to achieve efficient and timely data cleaning.
Our services include:
- Database set-up
- EDC systems implementation and training
- Full project managements and oversight
- Double data entry for paper CRF-based studies
- Thorough processes for checking and querying data through quality assessment and DBL
Our stand-alone system provides full services and data management throughout an entire clinical trial .
Effective clinical data management (CDM) is the core of any successful clinical trial. At Clinres Farmacija, we’ve made the collection and handling of clinical trial data a central part of our entire services.
Clinres Farmacija has an experienced team of clinical statisticians who have the therapeutic experience to provide you with the support you need. As clinical trials and regulations become more complex, it is important to work with a bio-statistician who understands the current regulatory environment.
Our experienced professionals provide the following clinical biostatistics services:
- Trial design
- Sample size determination
- Statistical analysis plan
- Randomization management
- SAS tables, figures and listings
- DSMB support
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Formal feasibility prior to study launch can prevent many patient recruitment challenges from becoming a potentially major hurdle. Clinres Farmacija has been recognized by all of 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 of the study.
During the Feasibility Assessment process we select 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 centers. Our extensive, proprietary database of experienced medical professionals helps us to quickly identify the right investigator to handle your clinical trial. We also utilize commercial investigator databases, relevant health care organizations, previous experience with sites, and your recommendations.
Clinres Farmacija’s long-term partnership with sites ensures close monitoring and support throughout the trial. In order to enhance site participation, we also 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 you in the optimal development of your clinical research program. Based on the results of the survey, Clinres Farmacija provides information and data-driven suggestions and recommendations with regards to the countries and the number of patients selected.
Our practice is to conduct blindfeasibility assessments; details about the client or the product which is being investigated are not revealed to the contacted investigation sites. A confidentiality agreement with sites is therefore not required, helping to expedite this initial stage of the process.
All questions from sites and Clinres Farmacija experts during the feasibility assessment process are collated 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 negotiation with hospitals and investigators.
Clinres Farmacija can use our site specific contract templates, or we are also happy to work with the ones provided by the client. The advantage of using our own contract templates is that this review will be much more streamlined and will shorten the time from the signing of the contract with the client to the approval of the clinical trial. Our experts will assist with drafting reasonable target budgets that control costs, while ensuring equitable compensation. We also draft alternative language and budget parameters, which serve as additional drivers for investigators’ motivation and involvement into the clinical trial.
We develop site budgets based on the study protocol and your approval. Working together with the project management we facilitate timely, accurate payments to investigators and organizations while delivering comprehensive, high-quality customer service to both you and the investigators. Our Investigator Grant database comprehensively tracks payments based on procedures performed, patient visits completed, milestone payments, and other measures as necessary. A grant payment summary is provided with each site payment.
Essential Documents Collection
Clinres Farmacjia has built a good relationship with sites, which helps us collect the site-specific documents for submission to the Competent Authority and Ethics Committee very punctually.
The average time we need to collect such documents is about a week’s time from the beginning of the process. An additional strength is that we have very well pre-defined templates of requested documents, which make them well accepted, recognizable, and do not require additional review and attention from the hospital administration and investigators.
At Clinres Farmacija our extensive experience in conducting clinical trials, combined with highly trained CRAs and thorough knowledge of local regulations and GCPs, allow us to guarantee the effective and efficient management of investigator sites.
Our Clinical Research associates can perform all types of visits, reviews of regulatory documents, training of investigators, resolution of queries, and preparation of Corrective and Preventive Action Plans.
Clinres Farmacija has adopted an internal rule that any issue identified at the site must be resolved within seven days.
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 — have more than FIVE years of experience in clinical research.
Clinres Farmacija has a successful record of low turnover, which improves the clinical monitoring process throughout the clinical trial life and leads to further improvement in Clinres Farmacija’s relationship with investigators.
As part of our commitment to high quality monitoring services, we provide our CRAs with a comprehensive training and professional development program, to help ensure compliance with applicable laws, regulations, and guidelines around the world.
Clinres Farmacija’s CRAs are office-based to maximize better study management, improve and personalize communication between different departments, and make teams embrace the goal of the clinical trial as their own.
Our experience with conducting clinical trials has yielded proven best practices and trials metrics, which allows us to efficiently and effectively monitor site operations.
The site management strategy we provide is to have constant contact with the sites and to be their trusted partner. Thus we assure robust prevention, which minimizes the risks of mistakes during the trial conduct; at the same time we gather valuable feedback, which is very relevant to our clients.
The clinical document translations we provide are both medically precise and culturally sensitive.
Clinres Farmacija is conducting clinical trials on behalf of pharmaceutical, biotechnology, and other life science companies. The challenge–and at the same time the opportunity–of getting data from patients with diverse national and cultural backgrounds makes an accurate and adequate translation of study documents even more important nowadays.
Accuracy and clear communication processes between client-investigator-patient are not only for obtaining informed consent, they also present a process of building a trustworthy relationship with a patient, thus improving 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. Often clients require us to perform back translations and reconciliation, cognitive debriefing, and harmonization of the patient responses, so that the data is accurate and consistent across languages. It is crucial to have clean data for the purpose of the actual data analysis. Faulty or inaccurate translations can render the trial inadequate and the drug company loses time and potential revenue.
Competent project management of clinical trials is one of the most important factors for the successful start-up, conduct, and completion of clinical trials.
Based on your specific research requirements, Clinres Farmacija assigns you a professional project manager, which ensures a sponsor’s contact point for all trial-related questions.
The regulatory framework for performing clinical trials in SEE is complex and varies from country to country.
After a project is awarded, the Clinical Trial Application process is executed by a dedicated team, comprised of 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, site contracting expert, project manager, and project assistant, 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 can understand and interpret the regulatory environment and offer different submission scenarios, which will speed up the overall study timelines.
Clinres Farmacija is always informed about the latest European Union Clinical Trial directives as well as of local changes in the regulatory frame on clinical trials.
Services we offer include:
- Submissions to regulatory bodies;
- Organization of study supply logistics, including obtaining import and export licenses;
- Organizing local insurance coverage.
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 mistakes can cause expensive re-work and can compromise the validity of the data.
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.
The Data Services Printing Solutions offered to our clients include the selection of paper, style of tab formatting, binder selection, and different graphics.
The Clinres Farmacija medical writing department is aligned with biostatistics and is composed of experienced professionals. Clinres Farmacija medical writers provide support to our clients at all stages of the medication development process.
Our team of dedicated medical writers 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, investigator brochures, annual safety reports and periodic safety update reports.
Medical writers are also consistent with the Clinres Farmacija therapeutic focus; each medical writer assigned to each project team has the appropriate therapeutic expertise to deliver a quality product. They 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, utilizing labelling and packaging which matches the trial protocol.
Through local dedicated warehouses, Clinres Farmacija can provide timely and cost-effective delivery of your study medications and medical devices to any country where we operate.
For the non-EU countries, such as Serbia and Montenegro, using a local warehousing company is a must, whereas for the EU member states (Bulgaria, Croatia and Romania) the client has the ability to ship investigatory medicinal products directly to the sites.
At our dedicated warehouses we offer both ambient and temperature-controlled (2 – 8 ºC) logistics, with temperatures monitored also during transit. At the end of the trial we can retrieve and reconcile unused medication and devices and complete all necessary steps for their destruction.
Through Clinres Farmacija’s streamlined IMP storage and supply processes, led by assigned specialists, we have the experience and expertise to make sure your study medication is always available where and when you need it. Years of experience enable us to import study medications quickly, to handle them properly, and to reduce the risk of oversupply and medication expiry dates.
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 your 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
- Medical writing
- Data management
Clinres Farmacija has been implementing and managing flexible staffing arrangements for some of the top-10 pharmaceutical and biotech companies since 2004. Clinres Farmacija’s governance team reviews performance metrics and meets regularly 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 the up-scaling of your work flow, we can provide staff for periods ranging from a week to a year or more.
- Functional Service Provision
When you need to outsource entire job functions to Clinres farmacija, we help with you develop a team with precisely the kind of qualifications you need to handle a single function across several programmes, 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.