With global regulatory changes happening quickly and often, there is concern that sponsors need more robust systems to keep pace and have a global disclosure strategy in place.
While several studies and surveys have examined the relationship between sponsors and CROs, there has been little analysis of CRO-investigative site relationships. This study uncovers useful learnings on the positive and negative experiences of investigators in their direct dealings with CROs.
By Applied Clinical Trials Editors
There are key cultural differences to be aware of before conducting clinical trials in Japan.
Japan is increasingly a region where opportunities for global registration studies abound, supported by government policies as well as the medical community and its local population. However, incorporating Japan as an integral part of your global trial execution strategy does not come without its unique challenges.
Bayer HealthCare has selected Oracle Siebel Clinical Trial Management System and Oracle Health Sciences Clinical Development Analytics.
Celgene has expanded its eight-year technology relationship with Medidata to add the Medidata Clinical Cloud® as its enterprise technology platform.
PPD has expanded Preclarus, its clinical data platform, to enable study sites to access central lab data in real time, and improve inventory management and order tracking, among other features.
Through collaboration with leading technology providers, pharmaceutical researchers, and ERT scientists, the Lab is developing and testing diverse technologies for use in clinical research.
Using performance indicators in CRO/Vendor oversight ranges from the basic, to the unreliable to emerging innovations and strategies.