Clinres-nova is a contract research and consulting organization that provides clinical and regulatory expertise to the pharmaceutical and biotechnology industries
Clinical Research
Study Management
We have expertise in bringing medical infromation, media and patients together to understand the advantages of your product.
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Regulatory Services
Expertise & Experience
Co-ordination with authorities, client representation, MAH services, Pharmacovigilance, Translation services.
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Statistics and Medical Writing
From Sample to Report
From estimation of sample size, randomisation schedule and statistical plan to full analysis and ICH compliant reports.
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Data management
Paper and Electronic
With almost 20 years of experience in all aspects of data management, we offer full range of services in paper and electronic data management.
DetailUpdates and Links
Relevant information regarding dossier upgrade and readability testing at Croatian Agency's for Medicinal Products and Medical Devices pages.
...to the Act concerning the conditions of accession of the Republic of Croatia.
As of 21 July 2012, new requirements for marketing authorisation applications are introduced in Directive 2001/83/EC.
Atemplates for product information for use by applicants and marketing-authorisation holders. The European Medicines Agency's Working Group on Quality Review of Documents (QRD) develops, reviews and updates these templates.
Readability Testing
One of the key services in documentation (dossier) upgrade in process of joining the EU.
We were among the first in Croatia to offer extensive readability testing to our customers. Over the years, we assembled an experienced and well trained team, flexible in solving readability issues in light of the approaching deadlines.
MoreOur Experience
Our customers include pharmaceutical, biotech, device companies and contract research.
Some of our partners are Acraf S.p.A., Alkaloid a.d., Amway Corp., AstraZeneca, Boehringer Ingelheim, Bosnalijek d.d., CSC Pharmaceuticals Handels GmbH., Cyathus Exquirere Pharmaforschungs GmbH, Eli Lilly....
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