Why not take advantage of a multi-environment platform by offering the ability for a program leader or any sponsor / CRO management role to oversee the progress of several DSMBs at one glance? This is the purpose of the eDSMB® supervisor profile. Different from the coordinator role attached to one study, the supervisor profile has access to data segregated for all the studies managed under the same umbrella.
A clinical drug development program typically consists of several clinical studies, some of which may run in parallel. Whether managed internally or outsourced to a CRO, more than one study in the program may have a DSMB in place so in a typical technical sponsor or CRO environment, several studies are set up under the umbrella of a larger clinical program. With the new features built in eDSMB®, Ethical recognizes the value for customers to have access to data segregated not only by study (through the coordinator profile) but also by program (through the supervisor profile).
The supervisor role is perhaps less common in other eClinical platforms than the coordinator role. It is nevertheless a useful profile for individuals in a managing position who need to oversee several studies and understand how the DSMB meetings run by their department are managed.
When entering eDSMB®, the supervisor has access to a central dashboard page where all useful summary information is available, for example how many meetings of each DSMB managed by his/her team have taken place, when are the next meetings, if the past meetings are complete or if documents are waiting to be signed. The supervisor also has access to useful statistics such as the average time between a meeting creation and closure or the number of meetings awaiting confirmation that can be used to improve performance metrics. Finally, the supervisor can choose to access a specific study page with useful metrics and audit trail information for this study. If needed, Ethical can allow the supervisor to access all meetings’ information and documents. Similarly, Ethical can adapt the dashboards and statistics to most customer needs.
Example supervisor profile page in eDSMB®
The benefit of monitoring performance for a manager is to be able to take corrective action on time when a weakness emerges. The weakness may be internal to the sponsor or CRO, or be due to an external reason including the experts themselves. In both cases it is essential to identify and resolve the issues and revert to a situation where the workflow is optimal. It is in the interest of the sponsor and in the interest of the experts.
Ethical is constantly exchanging with its customers in a continuous effort to understand their needs and find practical solutions that can be incorporated as quickly as possible. The creation of the supervisor role is a prime example of two-way communication and prompt action and we are looking forward to continuing improving our products to stay close to our customers and help them streamline their business every day.
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