Every quarter, Synergy Research Group, a full-service CRO headquartered in Moscow, Russia, issues its Orange Paper. The report, which looks at the state of clinical trials in Russia, is comprised of research done by combing through data from the country’s Ministry of Health. The Orange Paper offers a concise snapshot of clinical trials in the region.
The Q2, 2014 Synergy Orange Paper was just released. One of the more significant findings is that the gap between previous years’ trials and the current period is closing. In the first quarter of 2014, there were 18 percent fewer trials than in the same quarter in 2013. In the second quarter, there was a gap of only three percent.
New global regulations have forced the concept of pharmacovigilance to expand beyond just identifying adverse events. Today pharmacovigilance is on the minds of every pharma and bio executive, and it starts earlier in the drug development process. By Dan Schell, Life Science Leader magazine
Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.
At INC Research/inVentiv Health we have the ability to expedite clinical programs and build the foundation for continued development of the product.
According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such patients and when renal impairment is likely to mechanistically alter the PK of the drug and/or its active metabolites.
Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN) announces today that Immunovative Therapies, Ltd. ("ITL") has been granted regulatory clearance from Thailand authorities to advance its lead AlloStim™ immunotherapy product candidate to the Phase II/III clinical development stage in advanced metastatic breast cancer.
Kinexum and Pennington Biomedical Research Center announced plans to establish an integrated approach for emerging companies and early stage therapies to achieve high value regulatory and early phase human clinical trials.
Xcovery, a developer of next-generation targeted therapeutics for cancer, today announced that investigators will present data from its Phase 1 clinical study which evaluated X-82, an oral VEGFR tyrosine kinase inhibitor (TKI), in patients with advanced solid tumors.
iCardiac Technologies, Inc., a provider of next generation cardiac core lab services, announced recently it has recorded another increase in its growth rate.