CClinical trials are an expensive but essential part of a sponsor’s existence. Unless the articles are being tested in the most efficient (yet still safe and com- plete) way possible, costs of development can rapidly become excessive and needlessly increased. Because testing must include multiple phases and com- ply with many strict regulations (which also vary between countries), it is essen- tial that companies efficiently organize and manage their trials. With the recent disclosures about problems with drugs on the market (such as Vioxx) and calls for investigation into others, sponsors now, more than ever, must be extremely vigilant in the eyes of both the regulatory bodies and the general public. That it is necessary for sponsors to implement controls that demonstrate their trial results cannot be questioned. If a sponsor contracts with a clinical research organization (CRO) to run a trial on the sponsor’s behalf, the sponsor will most likely be looking for those controls from the CRO. The CRO’s use of a CTMS to enforce adherence to the sponsor’s rules will go a long way towards providing the needed reassurances.
A CRO needs a tool that increases efficiency, productivity, capability, perfor- mance, and internal communication, as well as communication with the spon- sor. A tool that helps decrease manpower, and administrative overhead also helps decrease associated costs. These benefits, in turn, can be passed on to a sponsor, giving the CRO a competitive edge. This paper helps to outline some of these key benefits.