Science and research

Support, innovation development and implementation of the clinical research at national and multinational level.

Clinical trials and projects
Services
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Clinical trials and projects

National and multinational clinical trials on medicinal products and medical devices, innovative therapies, diagnostic and surgical procedures, optimisation, and infrastructure development projects.

SLOVACRIN conducts scientific research activities

SLOVACRIN carries out scientific research activities at national and international level. It focuses on clinical research and the implementation of non-commercial clinical trials and projects. Non-commercial clinical trials account for a minority of the trials conducted in the Slovak Republic, as well as in Europe and worldwide. However, it is essential to support independent clinical research that addresses a variety of relevant clinical issues. Clinical trials do not include only trials of new medicinal products, but also trials of new treatments, medical devices, diagnostic and surgical procedures, as well as optimisation of existing drugs and procedures to promote better health and well-being. Supporting academic research brings major advances in medicine, and present patients with the opportunity to have tailored treatment. The discovery of new molecules, markers, and better understanding of signalling pathways and processes in the human body aids diagnosis, enables earlier diagnosis, and optimizes therapy, thus allowing diseases to be treated in a more targeted manner. Implementation in practice is also more efficient and faster thanks to such unique infrastructure. The connection between research organisations of each country creates a unique cluster with direct impact on the patient and their prognosis.

Services

Research, knowledge, methodological and service support in the implementation of clinical trials and projects.

Project management

Project management

Coordination of project activities

Regulatory

Regulatory consultations and activities

Consultation on project/study feasibility

Preparation of national regulatory and other documents

Consultation on local quality documents

Contract negotiation support

Other related regulatory activities

Monitoring

Monitoring activities and consultancy, including preparatory activities and feasibility questionnaires

Monitoring visits such as initial monitoring visits, regular monitoring visits and close out visits

Discussion of clinical trial status

Review and collection of case report forms, completion of monitoring visit reports, clinical trial management, review and archiving of clinical trial documentation

Serious Adverse Events (SAE) reporting and monitoring

Participation in training and meetings

Resolution of emerging issues

Pharmacovigilance

Local pharmacovigilance and consultation

Pharmacovigilance case management, including quality control of safety information

In-country safety reporting, i.e., Development Safety Update Report (DSUR), line listing, reporting of Suspected Unexpected Serious Adverse Reaction (SUSAR) according to the applicable legislation

Advice on pharmacovigilance requirements

Participation in teleconferences or face-to-face meetings

Education

Training on regulatory aspects and pharmacovigilance in clinical trials

Training as required

Project management

Regulatory

Monitoring

Pharmacovigilance

Education

SLOVACRIN supports the development of clinical research through academic clinical trials as a fundamental source of innovative clinical practices in diagnosis, treatment, and prevention in healthcare by providing research, knowledge, methodological and service support in the implementation of academic clinical trials and projects.

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Request for cooperation with SLOVACRIN and the services provided.

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