With SiteZone, Site personnel don’t need accounts created in the sponsor’s domain. Wingspan manages the user’s credentials, manages forgotten password requests, tracks completion of required training, and alerts sponsors to any change in vital information such as user email address.
The Site Administration module places responsibility for managing the sites with the person who knows the most about it – the CRA. The CRA identifies site personnel by email address, proving access to the study in a specific role. The CRA can review the list of all site personnel with access to the study including their last access time to see who is logging in to SiteZone. If personnel are no longer working on the study, the CRA can deactivate them without the need for IT support.
Site-level documents account for 80% of the average TMF. The key to making collaboration work for sites is to decrease their administrative burden, not increase it. SiteZone organizes information, documents and requests in an easy to manage way through its User Home Page, Document Library, and Study Information tabs.
The User Home Page provides the user with a list of sites that he or she has been registered for – even across multiple sponsors and investigational products. When a user accesses the home page for the first time, he or she will be prompted to complete a short (five to ten minute) video training module. Users accessing a specific study will also be prompted to accept sponsor-specific agreements.
SiteZone provides an easy-to-navigate library of essential documents, including both documents provided by the Sponsor/CRO and documents provided by the site. Qualified users can download copies of individual documents, or download all document to support their Investigator Site File (ISF).
Each study has an information page that provides CRA contact information, site milestones, a list of site personnel, and more. Sites also see how they stack up in terms of providing requested documents on a timely basis, acknowledging documents, and completing other task that contribute to the smooth conduct of the study.
SiteZone generates tasks that provide site personnel with clear direction on what they need to do to participate in the trial. All tasks actions are audited. Tasks include:
Requests for Documents
SiteZone automatically requests documents from sites prior to their due dates without the need for the creation of time-consuming document request packages. Requests can be fulfilled by any site staff unless specifically directed otherwise. Users are provided with the ability to download a suitable template and submit the requested document by simply dragging and dropping. Documents are automatically sent for QC within eTMF and filed in the eTMF upon approval.
Requests for Signature
Users are prompted to electronically sign documents for which the regulations or sponsor/CRO policies require signatures.
Requests for Acknowledgement
If the sponsor/CRO requires that receipt of a document or reading and understanding a document are acknowledged, the recipient will be provided with instructions and asked to acknowledge.
Users can be informed of events such as certain types of new documents, as well as general events such as site visits. These events do not require acknowledgement.
SiteZone provides an innovative solution to managing the workflow between sites, sponsors, and CROs. It solves many issues customers face with other solutions on the market such as site portals. See how SiteZone compares to other solutions.
Impracticality of provisioning site users credentials with the organization’s own infrastructure
Site personal credentials created and managed for you, without burdening IT
Delays in providing (or removing) access to specific trials
Business users provide timely access to site personnel who need it- and remove it when they don’t
Difficult to use or non-intuitive UI
Intuitive UI that guides users through their main tasks and allows them to ask questions
Complex signature process
Simple signature process involving only username and password
Inability to monitor site progress in providing or acknowledging documents
Overdue documents, outstanding requests, and file completeness instantly visible
Cumbersome processes for exchanging documents with sites
Automatic push to sites; automated requests for site documents when needed
Need for sponsor/CRO to manage and monitor training and agreements
Five-minute integrated training process and completion of agreements before trial access
Site impression that there is no benefit to them
Ability for site personnel to use SiteZone across trials and sponsors, and to extract their ISF documents with one click