An overview of regulatory environment, patient enrolment and site contracting in CEE
Cost of clinical trials has been increasing dramatically in the past few years. This has lead pharmaceutical companies to look for solutions outside the traditional clinical trial regions of Western Europe and Northern America. New geographical locations always bring questions such as: How to identify the right investigators and sites? How is the regulatory environment? How to recruit patients efficiently in the area? How is the quality?
In our webinar we address these concerns from the Central and Eastern Europe (CEE) point of view, which has been an emerging region for clinical trials in the first decade of the millennia. We will explain with case study examples how the regulatory authorities work and how to identify the right investigators and how to tap into the drug native patient pool together with fast recruitment.
Contract negotiation with the sites also plays an important role in starting the study on time and in preventing later legal issues. Delays in contracting may significantly inhibit patient enrolment and may cause a lot of concerns and issues. Based on our experience, most problems related to contracting are caused by a few factors:
a) lack of understanding of US contracting techniques and US legal requirements on the part of sites;
b) inability by sites (and CROs) to translate to the sponsor their local legal requirements and contracting techniques;
c) lack of flexibility with respect to sponsor´s templates for contractual documents;
d) insufficient capability of CRO to predict possible delays in particular situations;
e) organizational deficiencies in the procedure of contracting;
In this webinar, we will address all these challenges and show on real life cases how they can be addressed to fully satisfy both sites and sponsors.
Presented by
Jakub MacháÄek,
Head of Clinical Operations
Jakub is based in Prague, Czech Republic and is responsible for overseeing operations in Central and Northern Europe. Jakub has a degree from the University of Veterinary and Pharmaceutical Sciences. He has worked in the CRO industry since 2003. He has been involved in allergology, dermatology, gynecology, internal medicine, neurology, oncology, psychiatry, pneumology and rheumatology studies.
Michaela Madlova,
Clinical Trial Manager
As a clinical trial manager, Michaela is responsible for the study conduct on a country level from startup to closeout. She plans, manages and executes all study related activities within the company ensuring the timelines and quality of study deliverables in accordance with SOPs, ICH/GCP guidelines and local Regulations.
Sarka Specianova,
Director, Neox Academy
Sarka is a lecturer in the area of medical law as well as social and legal protection of children. At Neox, Sarka is responsible for legal aspects within different areas and for negotiating contracts with the hospitals and sites. As the Neox Academy Director she is responsible for the complete educational program. Before joining Neox in 2009, Sarka worked as a hospital lawyer in one of the biggest hospitals in Czech Republic. She has also been an active member of an Ethics Committee since 2003.
Miroslav Specian,
Head of Legal and Business Contracts
Miroslav has more than 10 years of professional experience throughout the spectrum of legal professions and roles. Prior to his postgraduate (LLM) studies in the USA in 2012, Miroslav was a licensed attorney at law in Prague. In 2013, he took over the responsibility for NEOX´s expanding international infrastructure and now works closely with NEOX´s business development professionals.
