Feasibility Studies Featured Articles
-
Quality Of Outsourced Trials: Why Do Disconnects Still Exist Between Sponsors And CROs
7/14/2015
The requirement for quality during the conduct of clinical trials is an absolute; a given that few in the pharmaceutical, biotech, and CRO industries would debate. Yet longitudinal survey data collected by The Avoca Group highlight that disconnects - the definitions of what constitutes quality, alignment on required levels of quality, and success at delivering to these expectations - continue to exist. Business models for designing and implementing clinical trials require that multiple stakeholder organizations (e.g. pharma/biotech, CROs, co-development partners, and regulators) align on and successfully implement to mutually agreed quality expectations.
-
Outsourcing Insights From The President Of A Virtual Drug Discovery Company
4/16/2013
Carolyn Green, is the President and Director for Atreaon, Inc., a privately held biopharmaceutical company developing a novel engineered protein called Atsttrin, for the treatment of inflammatory diseases such as rheumatoid arthritis. Having recently completed a $20 million Series A financing to support the pre-clinical development of Atsttrin, Green took time out from her busy schedule to share some of her thoughts and insights regarding the outsourcing of clinical research.
-
Toxicometabolomics For Compound Attrition To Reduce Late Stage Failures Due To Safety
4/10/2013
Many ’omics’ technologies have now become the primary way of discovering new biomarkers, and validation of these biomarkers is a relatively new and evolving concept. By Michael V. Milburn, John A. Ryals, and Lining Guo
-
Changing The Outsourcing Paradigm – Who Is RDP Clinical Outsourcing?
5/1/2012
RDP takes a unique approach to the outsourcing of clinical services. We employ strategies wherever possible to exceed the goals of our sponsors in cost and timelines while maintaining excellence in quality.
-
Insights And A Peek Into The Future For PRO & ePRO
12/12/2011
PHT Corporation’s U.S. PRO & ePRO Congress, held in Boston Nov. 9-10, shared electronic patient reported outcome (ePRO) adoption growth numbers, discussions of new regulatory guidance, actionable information that can ease site and study subject burden from ePRO, PRO and ePRO in post-approval, and lingering reasons for sponsor reluctance to adopt ePRO. By Sara Gambrill