Today, Europe is undergoing rapid changes in the field of Clinical Research. Western European countries like Germany, the Netherlands and the United Kingdom have decades of experience and are home to many opinion leaders in Clinical Research.

These countries can be extremely important to Sponsor Clinical Program in order to boost acceptance after launch of your new product.

On the other hand, South East European countries (SEE) such as Croatia, Serbia, Macedonia, Bosnia and Herzegovina are areas with high numbers of treatment naïve patients. These countries have GCP implemented in their laws and regulations and 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 expenditure.

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.

Cultural difference: Business management and team building practices differ between cultures. Indeed, cultural values and behaviors present benefits and challenges for multinational trials. For example, differences in cultural values influence important clinical trial components such as contracts, customs, billing and cash collection, investigator training, learning methods, content of training materials and the staffing of quality assurance teams.

Language difference: Sponsors are relying increasingly on English as a global language. However, local physicians work with patients in their native languages. Cost implications here involve the cost of translating protocols synopsis, informed consents, questionnaires, source data, adverse event reports, and even training content. Therefore, language differences will probably require additional attention and resources during a multinational trial.

Complex administration: Each country involved in a multination trial maintains quality standards but very often differs in the process of the approval of a clinical trial. Certain key differences in the way IEC/IRBs and Regulatory authorities work will likely affect the success of clinical trials.

For a trial to be successful in this market, it is essential to have local partners who understand all of the regulatory, medical, and cultural issues in the countries where the trial is taking place. A regionally-based CRO assures  pharmaceutical company to access expertise that may not exist internally, assign appropriate resources to project tasks and obtain quality strategic input into the drug development plan. Thus, regionally-based CROs can facilitate communication by minimizing cultural and administrative barriers.

We can give you access to this unique combination for conducting Clinical Research. We know the different regulatory approval procedures, local laws and cultural aspects which have to be addressed when performing Clinical Research in the CEE and see regions.

Importantly, the regional distribution of Clinres Farmacija's CRAs reduces site-related traveling time and expenses which means that Clinres Farmacija can offer immediate  site access for prompt resolutions of any problems or queries that inevitably occur in any multinational trial.

From small local trials to complex multi–sponsor, multi–national programs, we have resources and experience to help you achieve your goals effectively.

Medical Writing

Clinres Farmacija medical writers provide support to our clients at all stages of the drug development process. Medical writers work on clinical study reports, patient narratives, regulatory submissions, manuscripts, protocols, newsletters, posters, investigator brochures, annual safety reports and periodic safety update reports.
They possess both significant scientific strength and substantial international writing and regulatory experience.

Feasibility Studies

Formal feasibility prior to study launch can prevent many patient recruitment challenges from becoming a potentially major hurdle. Our Medical 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 proactively recommend protocol revisions to sponsor, if needed.

Project management

Competent project management of clinical trials is one of the most important success factors for successful start-up, conduct, and completion of clinical trials. We assign a single project manager to each trial, which ensures sponsor's contact point for all trial related questions.

Translation  and back translation of study-related documents into local languages

Clinical Study Agreements

Our team negotiates clinical study agreements using a mutually acceptable clinical study agreement template. Our experts will assist with drafting reasonable target budgets that control costs, while ensuring equitable compensation. 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.

Clinical Grant Management

 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. We routinely complete grant funding projections and grant payment reconciliation.

Investigator Meeting Coordination

We will arrange the meeting location, meeting logistics, travel and accommodations. We have extensive knowledge of venues suitable for the smallest Phase II study to the largest Phase IV study.

Regulatory document submissions (RA and EC application)

Clinical trial can be greatly jeopardized if regulatory/EC submissions and updates are not done perfectly. Members of our team with high expertise in regulatory requirements for a country within the region in which you want to start the clinical trial will provide you with the list of documents required, specific country regulations and timelines for submissions and approval as soon as possible. Starting from contract negotiations, translation requirements and compilation of submission files, we will ensure proper submission with complete and quality documentation. Understanding of country specifics in approval process will lead to reaching the goal in mutually agreed planned time. Once the clinical trial is approved and on the right track, we maintain the level of professionalism in all further submissions and notifications in accordance with all applicable regulations and laws, assuring top quality of regulatory requirements and thus validity of data retrieved.

Clinical Monitoring

One of the greatest challenges associated with any clinical trial is quickly initiating the project—or risk losing valuable time and money. We understand the importance of accelerating this process. That’s why we’ve structured ourselves in a way that streamlines the process.
Our Clinical Trials Services team provides clinical monitoring and management of the investigative site and is the main line of communication between the sponsor or contract research organization (CRO) and the investigator.
In general, there is on-site monitoring before, during and at the close of the clinical trial, but the extent and nature of monitoring are determined by the purpose, objectives, design, complexity, size, endpoints and requests of the sponsor. Thus, clinical monitoring is conducted to verify that:

Upon study initiation, you need a trusted outsourcing partner who can quickly collect site data without compromising that data’s integrity. Successfully completing this component of the project requires experienced professionals who are dedicated to delivering superior results under pressure.
Clinical monitoring and site management are conducted by Clinical Research Associates (CRAs), or monitors, who are knowledgeable of the protocol, the investigative product, informed consent and written information provided to subjects, the sponsor's Standard Operating Procedures, Good Clinical Practice, and the applicable regulatory requirements.

Our CRA’s have experience in a variety of therapeutic areas and are highly educated professionals (MD, B.Sc.Pharm, DDS). All CRAs are regionally based, maximizing on-site time and lowering travel costs, native speakers and have knowledge of the local laws and regulations.

Our training program provides consistent training in Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) Guidelines, and regulatory requirements. The support and availability of our Medical Directors provides therapeutic training and a continuous resource for our CRAs.

Moreover, we established Proactive Management Structure, we’ve structured ourselves to offer our CRAs unparalleled support and strong leadership. Each CRA reports directly to an experienced Project manager who strives to engage and support CRAs, while also conducting hands-on training and evaluation in the field.

Data  management and biostatistics

Services can be tailored or encompass broader biostatistical requirements:

We provide safety services which include, but are not limited to: case review and evaluation, case coding, e-submission of expedited reports to EMEA and Regulatory authorities trough EudraVigilance system; preparation and submission of periodic safety reports across EU and non EU countries in Europe; managing of submissions of expedited and periodic safety reports in non-EU countries; medical monitoring activities: monitoring the safety of study participants throughout the trial, identifying of safety signals and safety trends, ongoing risk/benefit assessment, providing of Safety Trainings to all responsible personnel and other project specific safety related activities as agreed.

Clinical supplies management

 

• Clinical Trials
• Regulatory Affairs
• Readability testing
• Pharmacovigilance
• Resourcing solutions
• Support Services

 

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