Conducting clinical trials in the Czech Republic with Cromos Pharma

Conducting clinical trials in the Czech Republic with Cromos Pharma

Cromos Pharma has been managing clinical trials in the Czech Republic since the 2010s and established a permanent office in its capital Prague in 2015. Czechia is recognized as an attractive location for international clinical trials with a strong track record for producing high-quality data and lengthy experience in Good Clinical Practices provided by the ICH-GCP.
Czechia is recognized as an attractive location for international clinical trials with a strong track record for producing high-quality data and lengthy experience in Good Clinical Practices provided by the ICH-GCP. Cromos Pharma has been managing clinical trials in the Czech Republic since the 2010s and established a permanent office in its capital Prague in 2015.

Read Cromos Pharma’s Czech Republic Country Profile here>>

The advantages of conducting clinical trials in Czechia

  1. With a population of just over 10.6 million, the Czech Republic offers excellent recruitment potential due to its large population of modern treatment-naïve patients in a wide range of therapeutic areas.
  2. It is recognized as an attractive location for international clinical trials with a strong track record for producing high-quality data and lengthy experience in Good Clinical Practices provided by the ICH-GCP
  3. The Czech Republic is the second largest pharma market in Central and Eastern Europe – valued at €2.95 billion in 2019.This pharma market has demonstrated strong growth in recent years in the innovative drug market – €1.6 billion in 2021.
  4. Its regulatory authority the State Institute for Drug Control (SUKL) has a reputation for being open, efficient, and supportive in its approach to supporting clinical research. This allows for quick approval periods and expedited start-up timelines (on average 60 days).
  5. The country has a Universal Healthcare System conducive to patient enrollment. In addition, it boasts a large network of public hospitals and clinics as well as specialized centres for patients with specific diagnoses.
  6. The country has a large pool of highly educated and skilled medical professionals with 10 medical faculties in 6 universities including the internationally renowned Institute of Clinical and Experimental Medicine (IKEM) in Prague and Masaryk Memorial Cancer Institute (MMCI) in Brno.
  7. An EU member since 2004, its clinical trial regulatory and legislative framework is harmonized with EU directives in relation to clinical research.

EUCTR

The way clinical trials are conducted in the EU will undergo a major overhaul when the Clinical Trial Regulation comes into effect. The Regulation harmonizes the assessment and supervision processes for clinical trials throughout the EU via a publicly available Clinical Trials Information System (CTIS; formerly the EU Clinical Trial Portal and Database). The European Medicines Agency (EMA) will set up and maintain the new information system, in collaboration with the member states and the European Commission. It is currently estimated that the Regulation will enter into effect by January 2022.

About Cromos Pharma

Cromos Pharma is a US-based, international contract research organization delivering fully integrated clinical research solutions, in all trial phases, across a wide range  of therapeutic indications. Our expert team, comprised of 95% MDs, has extensive expertise in study design, medical writing, regulatory affairs, site management, patient recruitment and data management.

Cromos Pharma has experience in delivering success in a wide range of trial types, from biosimilars and generics, to successfully managing trials of novel therapeutics in a wide range of clinical indications. Our team provides full-service solutions to international pharma and biotech companies in high-recruiting regions, assuring exceptional data quality. Cromos Pharma combines global expertise with in-depth experience and knowledge in the US, Central and Eastern Europe, Central Asia, Republic of Georgia, and Turkey to offer exceptional patient recruitment. Our team has met or reduced enrollment timelines in 95% of conducted trials. 

We provide accelerated study  start-up timelines in our regions of operation. Regulatory inspections by FDA and EMA and site audits attest to the highest quality of our clinical data.

Established in 2004, Cromos Pharma has strong regional experience that is supported by a global network of offices. Its international HQ is located in Portland, Oregon, USA and its European HQ is in Dublin, Ireland.

If you have any questions or want to find out more about how Cromos Pharma can support your next clinical program please get in touch with us by emailing inquiry@cromospharma.com.

*page updated 14 October 2021 with new pdf link

CONTACT

BD@CROMOSPHARMA.COM

To arrange an introductory meeting and find out how our experience can benefit your next clinical project.