We are able to offer the preparation, implementation, conduction and evaluation of the clinical trials from Phase I - IV in any medicinal field and for medical devices. Mainly in the Czech Republic and Slovakia but of course in other EU countries. We built the team of experienced experts in Regulatory House under independent unit REKNOS Science s.r.o. We are ready to prove full maintenance of your clinical trials:

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To provide "one-stop-shop" for clinical trials of all phases

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• Assisting in Trial Design

• Assisting in Protocol Development

• Site Identification

• Study Setup

• Outsourcing of Clinical Study Coordinator

• Outsourcing of Monitors

• Education and seminars (GCP, Clinical Trials in Practice, Pharmacology)

• Professional translations
   

Single point access to the capacity and expertise

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• Access to university hospitals and healthcare provider facilities, clinical researchers and patients

• Clinical Trials coordination across the whole project network
   

Implementation of the clinical trials
 

• Methodological support for clinical trials

• Medical writing

• Start-up Phase, legislative support

• Regulatory support and submission

• Biometry (data management, biostatistics)

• Clinical Trials Monitoring

• Pharmacovigilance
   

Control and quality assurance
 

• Support for the creation of the systematic and proper management of the projects in accordance with the requirements of relevant legislation and guidelines 

• Creating a basic set of sample Standard Operating Procedures (SOPs) for the processes

• Consultations on the formation of QA/QC

• Quality system/ GCP Audits