Overcoming Clinical Challenges in BRIC Markets - Russia
Thomson Reuters Cortellis Competitive Intelligence
Read the first installment of this report on Brazil here.
Figure 3A:
Current clinical trial approval timelines in Russia average three to four months. However, unethical conduct in the country has been revealed in surveys and remarks by sponsors. Biogen Idec provided an example at the global clinical trials conference: in 2013, the company shut down all Russian sites for a Phase II trial—representing one quarter of the study’s patients—because investigators did not want their trial income reported to the state employers. Although it does not appear that global sponsors are largely pulling out of Russia, clinical trial initiation has declined in number since its peak in 2012.
SOURCE: Thomson Reuters Cortellis Competitive Intelligence
Read the full report here.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
