Proveca Ltd is a pharmaceutical company specialising in identifying, developing and licensing off-patent medicines with unmet priority health care needs, with a focus on the pediatric market. Proveca recently gained a European license for a medicine to treat chronic drooling in children, often associated with neurodisabilities. Proveca are now conducting a study to assess the value of educational materials provided to healthcare professionals and carers
The rigorous processes and procedures required for conducting any clinical trial presents challenges for data capture and recording, both during the trial and for subsequent analysis and auditing.
Clinical trials often use paper based case report forms for collecting data but this can increase the risk of error, particularly when transcribing the data to a database for analysis.
Several databases exist for electronic data capture in clinical trials and these were assessed for suitability. The Proveca study requires minimal data capture at each patient visit and the existing solutions were too complex and costly with the majority of functions being redundant. Therefore, Proveca required a bespoke database solution for the proposed trial.
Clinical studies within the pharmaceutical industry are governed by the Good Clinical Practice (GCP). In order to comply with GCP and at the same time maintain patient confidentiality, different access levels were necessary depending on the role of the end user.
Proveca were therefore looking for a system that could allow granular data input, appropriate output for analysis and assistance with final data analysis. And - a software development house that were familiar with developing custom portals, had experience of holding highly confidential patient medical record information and to provide expertise for data analysis was required.
Blacklight Software identified that the best technology to utilise to achieve Proveca’s objectives was through a bespoke .NET web portal hosted in Azure. This software is flexible enough to build the content of the database to Proveca’s exact requirements, whilst ensuring that the data could be captured, stored and retrieved easily and quickly. As an Azure hosted portal, the system will allow the data to be thoroughly analysed at the end of the study, providing fast and straightforward retrieval of complex information, at the click of a button.
To solve the challenge of adhering to the governance on patient data records and ensuring compliance with GCP, Blacklight Software built a new SQL database to create the permissions Proveca required for the different levels of access to the data. Aware of the extra security requirements patient record data presents, Blacklight Software selected Azure hosting for the secure data storage, reducing the investment in infrastructure as well as saving time and cost on data security measures for Proveca.
Blacklight created a user-friendly format to ensure the portal was easy to understand, simple to follow and allowed rapid data input. The result provided a user-friendly web-based portal to ensure a positive user experience and enable continued clinician involvement in the study. As a bespoke .NET web portal, the site is desktop, tablet and mobile responsive to ensure it is futureproofed and requires no additional development time to create a mobile platform.
Blacklight Software created a UI for Proveca to manage the restrictions, user profiles and admin rights in house to facilitate ongoing study recruitment of new investigators and allow self-management of the delivered system. The capability to run intuitive reports on the data ensures that Proveca have a 360-degree view of their drug trial, allowing variables to be analysed and explored quickly and in context. adding real value and time saving to the study.
Dr Helen Shaw