The UK’s Health Research Authority’s greatest need was to digitize the paper-based application submission and approval process. In addition to that also to increase its efficiency while also speeding up the processes surrounding ethical review and approval of R&D studies in the country. The main wins were digitization and simplification of the current process, which could lead to a more comprehensive, faster, and accurate review process.
The Authority contacted several technology companies including big players like Oracle, etc., in order to find a way to meet the new clinical trial applications submission, management, and approval standards for all study types. BGO Software met the requirements and created a digital ERP solution for the Ethics Committees that process clinical trial applications, manages their status and returns information to the applicant in real-time.
The Solution in a nutshell
The HRA Assessment Review Portal (HARP) is web-based management information system that tracks the progress of Health Research Authority -submitted research applications. HARP also manages the application process for so called RECs meetings - Research Ethics Committees. HARP provides REC members with access to a member’s portal where they can view applications and amendments electronically. This enables members to efficiently share their ethical comments with one another, keeps records and measures the time it takes to make award decisions, generates correspondence, manages meetings and contacts, and creates research summaries. The system could provide customized reports that could facilitate the workflow of the RECs.
BGO Software had nine months to build from scratch and completely replace the existing ten-year-in-development government solution. This required the transformation and migration of very large volumes of data into a completely new format, and last but not least the replacing the existing paper-based process.
One of the main challenges our team had to overcome is the type of data HARP contains and manages. The information held in HARP is strictly confidential and therefore, access must be restricted to authorized users only. Many additional integrations were made to ensure the confidentiality of all participants in the assessments.
The highly efficient two-way communication and data exchange methodology adopted by the customer and BGO Software teams ensured successful project completion within strict deadlines. To manage the complex data analysis and migration, the team developed a new data format and sophisticated tools, capable of transforming and migrating large data volumes from the old software to HARP.
BGO Software successfully deployed new functionalities that contribute to the system’s efficiency and capabilities for:
Simple log in and registration for R&Ds for booking applications onto Research Ethics Service
REC members access a personal portal, which enables them to view full, proportionate and or substantial amendment applications electronically
The national Health Research Authority to be more efficient and environmentally-sustainable as an organization
A sophisticated new approach to a regulatory system for research assessments in the UK.
HARP proved able to migrate large amounts of data in order to allow flexible workflow management and of course making all integrations, migrations and additional functionalities in the web-application as secure as possible.
More outcomes that bring value every day to the users:
- The digitized process impacts the whole research community, more 100 000 users and 150+ Research Ethics Committees (RECs)
- The functionalities of HARP allow administrators to track the whole clinical research trial application review process, as well as post-approval monitoring and reporting.
- HARP also has a reporting module which gives the ability to make analysis not only on individual bases but to get the whole picture of the area that the applications are made, the time for which the decisions are taken, the number of the successful projects and other important statistics
- The system stores all the needed documentation which is attached to a project so a relevant decision can be made. It gives the ability of the RECs better to organize the reviewer process, to shorten the time for it and easy to request and receive the necessary documentation.
The most valuable feature that BGO created is the ability for different systems to communicate with one another, resulting in real-time updates that improve the efficiency of REC’s work.
From a system to an ecosystem
Following a successful launch in 2014, BGO has become a trusted partner of NHS, and we now have the opportunity to upgrade, add new features, and create an ecosystem that support the process progress as efficiently as possible.
Development of additional systems that support RECs by BGO
CAG (Assessment Review Portal)
The system is used by the HRA for all Confidentiality Advisory Group (CAG) applications. CAG portal stores all application documents; records the committee recommendation outcomes and is fully cross-functioning with HARP management system.
HAP (Health Assessment Portal) /HRA Approval Portal
TOPS (The Over-Volunteering Prevention System (TOPS)
It is run by the Health Research Authority and helps prevent volunteers from taking part in trials of new medicines too frequently.
- HARP was created
- Many new features were added. It was decided that HARP needed to be connected with two outside systems which take part of reviewer process. The purpose was to implement an automated way of communication between the systems on different steps of reviewing the applications.
- The new functionality was released and later was implemented in many other functionalities. This drastically changed the way of communication and additionally shortened the review and assessment of the applications.
- Next step is to move the application into the cloud and to take the advantages of this technology.