CRO PolandRegulatory authortiesEthics committeeClinical trials regulations

CLINICAL TRIALS IN POLAND

  • Poland is the largest market for clinical trials in CEE and stands for roughly 20% in terms of clinical trials number
  • Both patient participation and site penetration rates indicate a potential for growth.
  • The key drivers of the clinical trials market in Poland are the population size, efficient patient recruitment and high quality of data. The key advantages“ patient recruitment and quality of medical staff, are the most significant.
  • A population size of 38 million, combined with patients€™ willingness to participate in clinical trials, make the recruitment rates significantly higher than in Western Europe or the USA.
  • The high regard for doctors in society translates into patients who are more compliant with study protocols and medication regime.
  • Due to limited reimbursement budget, both pre-treated and treatment-nave subjects are available.
  • Patient treatment in a clinical trials is often superior to local standards of care which leads to high enrolment and patient compliance.
  • Investigators are eager and motivated to participate
  • Investigator€™s fee is paid directly to study team members
  • The most often tested therapeutic areas are oncology, neurology, rheumatology, pulmonology, diabetology
  • Here is the PWC report on Clinical trials in Poland


Check it

Clinical Trials in Poland€“ PRICEWATERHOUSECOOPERS REPORT
http://infarma.pl/fileadmin/badania_kliniczne_raport/Clinical%20trials%20in%20Poland%202010.pdf

PriceWaterhouseCooper Clinical Trials in Poland 2010 report
http://clinmed.eu.com/wp-content/uploads/2015/08/pwc-report-2010.pdf

Regulatory Authorities in Poland

ClinMed as a EU LEGAL REPRESENTATIVE for Japanese company. Each company that does not have their entity in European Union has to delegate its responsibilities to the EU company. More information on clinmed (at) clinmed.pl.

The initial Clinical Trial Application review process, conducted by RA in Poland typically requires 60 days, during which the reviewers will decide if an applicant is permitted to proceed with its proposed clinical trial. Additional information may be requested from the applicant, which could extend the review period.

ClinMed submission team is also experienced in Voluntary Harmonisation Procedure (VHP) of studies submission.

Regulatory Authorities and Ethics Committee submission can be done in parallel.

All the substantial amendments are approved within 35 days.

Ethicscommittee

EC is obliged to issue opinion for the initial Clinical Trial Application within 60 days All the substantial amendments are approved within 35 days Regulatory Authorities and Ethics Committee submission can be done in parallel.

Clinical studies regulations

Here are useful links regarding clinical trials in Poland Pharmaceutical law