Information about the site, it’s locations and research capabilities will include:
- Location services and capabilities;
- Storage, sample/IP preparation and waste destruction;
- Information technology; and,
- Medical emergency facilities (if applicable).
Enter Site Research Profile and Capabilities
As part of the registration process, contact information of other site based study personnel will be requested. Prompts will ask the user to complete minimal information on each role before performing a system search to assign the user to your account if the user is already registered. If they are not already registered, they will receive a notification inviting them to login and complete their profile.
The first location registered for your site profile will be identified as the principal location for the site. This principal location can be reassigned to another location by navigating to the location list in the site profile and changing the principal location using the icon displayed or from the actions panel.
Ancilliary Service Providers (ASPs)
Many clinical trial sites require the support of Ancillary Service Providers (ASP). ASPs support clinical trials by providing commercial medical services in support of clinical trials that typically do not merit professional recognition or publication privileges . AnovaOS captures these relationships for each site. ASP credentials are used for regulatory purposes in the conduct of research, to communicate studies, and to ensure a complete profile of site capabilities are communicated to sponsors conducting site feasibility and matching. As such, it is important that a full and complete profile of a site’s ASPs are captured to benefit fully from the use of AnovaOS.
AnovaOS will prompt a user to identify their internal and external ASP providers, and associated operational capabilities and regulatory documentation. ASP credentials can be collected for each clinical/research location registered as part of a site account.
Document IRB relationships
AnovaOS supports the submission and approval process for clinical trials and compassionate use programs. AnovaOS assembles essential documentation for submission to approved IRBs and so details of preferred/permitted local IRB contact information is required as part of the site registration process, including preferences specific to the use of external or independent IRBs.
Details of all major external IRBs are already in the system. When registering, a site can choose a preferred external IRB they use and the application will automatically prefill all details related to the IRB. Alternatively, a site can select ‘Any IRB’ from the list of external providers.
Enter laboratory credentials and capabilities
AnovaOS captures all capabilities of both internal and external laboratories used by a site in the conduct of research. Operational and regulatory information is captured to help match sites to studies and support subsequent regulatory and operational workflows.
Laboratory credentials can be collected for each clinical/research location registered as part of a site account.
Information about laboratory certification, laboratory director qualifications and laboratory test normal ranges are used to facilitate site activation and completion of essential documentation.
Register laboratory study personnel profile and qualifications
AnovaOS captures all Laboratory Director’s and Laboratory Technician credentials as part of the registration process for a site. Credentials are captured to meet regulatory requirements and in support of operational workflows in the conduct of research.
Laboratory study personnel details can be collected for each clinical/research location registered as part of a site account.
Enter imaging center credentials and capabilities
AnovaOS captures all capabilities of both internal and external imaging centers used by a site in the conduct of research. Operational and regulatory information is captured to help match sites to studies and support subsequent regulatory and operational workflows.
