Problem Summary
Upon thorough analysis of the current process, business requirements, and workflow within Vestigo, it has become evident that certain features, flows, and business aspects need enhancement to ensure heightened security and transparency within the system.
Protocol Budget: The Clinical Trial Office (Pharmacy) within an institution determines the initiation of a drug study (Protocol). A pivotal step in this process involves establishing the budget to cover the study's costs, which plays a crucial role in responding to the study sponsor. During this phase, the Investigational Pharmacy compiles a list of fees based on factors like the study phase, drug preparation, storage, and administration - all constituting the budget of costs. Presently, this procedure is typically executed using Excel and the resulting document is either printed or sent via email. However, this approach demands a substantial investment of time for the pharmacy team to create, manage, and locate these files as required, while also keeping them consistently updated with the latest fee structures. Furthermore, there is no mechanism to link the study once it becomes active, thereby impeding the monitoring of provided costs against the actual expenses incurred.
Protocol Checklist: The Investigational Pharmacy navigates through various stages and tasks that are imperative for the comprehensive execution of a protocol. A subset of these tasks, such as budgeting or Site Qualification, transpire prior to the protocol's approval at the site. Conversely, other tasks - like drug builds within their EMR system, Site Initiation Visits, and Vestigo build verification - transpire while the protocol is underway. Currently, sites resort to disparate Excel or Word solutions to track and allocate tasks that pertain to protocol development. Regrettably, this method is unwieldy and fails to integrate harmoniously with Vestigo's broader solution.
In light of these observations, it is imperative to enhance the aforementioned elements to bolster security and transparency within the system.
Development and Solution Architect
- Protocol Budget: It helps Investigational Pharmacy (IDS) with an electronic solution within Vestigo where they can build consistent and repeatable templates for budgets and use them when creating protocols. This will also save them the step of creating the protocol and configuring fees in Vestigo when the budget is approved.
- Protocol Checklist: It helps Investigational Pharmacy at several stages and tasks that must be completed to execute a protocol fully. Some of these tasks, such as budgeting or Site Qualification, occur before the protocol has been approved at the site. Other tasks, such as the drug builds in their EMR system, Site Initiation Visits, and Vestigo build verification, occur while the protocol is live.
Closeloop designed, developed, deployed, and maintained McCreadie Groups Vestigo software. A fully custom software platform for supporting all aspects of Vestigo business. Vestigo is integrated with 3rd party vendors and includes a full set of APIs for external partners to connect. The platform was conceptualized and delivered within 04-05 months, including frontend user interface, solution architect, coding (.Net, VB framework, SQL, JavaScript), QA, Training, and final deployment.
QA and Testing of the Software
Implementing Twilio and the automated user removal process required much more effort in the testing. Closeloop conducted rigorous testing throughout development to identify and resolve bugs or usability issues. Our QA team tested the released functionality in a dev environment, where the setup was built with the hardware used in production to ensure as many similarities as possible between the dev setup and the app developed.
Our QA team carried out the following activities:
- Functional Testing
- Testing of user association after the program ends
- User acceptance testing UAT support
Results
Closeloop developed and delivered two-factor authentication and automated removal process of preceptors, which resulted in -
- Reduction of approx 45% in daily support tickets related to password reset.
- Helps RPD to manage programs more effectively than earlier processes of handling programs
- It helps the resident to recover passwords easily
- Added additional security to the password reset process
