Clinical Trials Project Management
May 1st 2015Every trial starts with a budget, and a clinical trial study start-up process that can be fraught with delays. From contract negotiations, to managing a trial for a sponsor, to streamlining study start-up process, this eBook seeks to instruct others on best practices.
EMA to Scrutinize Trial Results for Malaria Vaccine
April 24th 2015The first malaria vaccine candidate (RTS,S/AS01) to reach Phase 3 trials is partially effective against clinical disease in young African children up to four years after vaccination, according to final trial data published in The Lancet, which will now be evaluated by the European Medicines Agency (EMA).
Synchrogenix, CISCRP Partner on Lay Summaries of Clinical Trials
April 23rd 2015Certara®, a global biosimulation technology-enabled drug development consultancy, and CISCRP, an independent nonprofit organization dedicated to educating and informing the public and patients about clinical research, announced that they are partnering to produce high-quality lay summaries of clinical trials.
Society for Clinical Research Sites Announces New Site Advocacy Groups
April 22nd 2015Since its inception in early 2014, the SAG initiative has exercised considerable impact on the clinical research landscape by inciting important dialogue between site professionals and industry leaders related to current and evolving practices.
WIRB-Copernicus Group Supports Accelerated Clinical Trial Agreement
April 20th 2015The ACTA was initiated in 2012 by the National Center for Advancing Translational Sciences (NCATS) through its Clinical and Translational Science Awards program in collaboration with representatives from several pharmaceutical companies to facilitate negotiations between institutional research sites and industry sponsors.