Collaboration is defined as the actions for individuals and teams to work together for a common goal. There are several bottlenecks to an efficient and effective collaborative model of clinical trial including: the lack of a centralized, consistent, globally accessible platform to manage and store essential study related documentation; inconsistent or incomplete work assignments; inefficient notification of key events requiring follow-on action; and incomplete, missing, expired, or redundant documentation and training activities and need to maintain multiple credential to access various system, Removing these barriers is an important part of establishing an environment that fosters collaboration among all constituencies involved in managing clinical trial keeping them connected, informed, and on task by providing access to everyone at any time, from anywhere.The case study below introduces need of an integrated clinical collaboration platform, addressing key functionality of such an platform and describes the architecture & design consideration to industrialize such a platform. The intended audience of this case study is the architects & designers of similar systems. The clinical trial activity for a drug in research is approximately 70% of the overall drug development cost. It is estimated that 4% of the cost of a trial is in 'rework' involving communication, regulatory issues, patient enrollment, document review and replacement of patients. The integrated clinical collaboration platform has potential to eliminate significant amount of cost of re-work, which is in order of $3.5M per trial.
The Disclosure Decision of Foreign Clinical Trials in China: Moderating Effects of Firms’ Contingencies