The UKCRC-Registered CTU Network
The UKCRC is a national resource for clinical researchers and funders wishing to identify Clinical Trials Units (CTUs) that have expertise in centrally coordinating multicentre clinical trials, as well as in trial design, data management, and analysis.
It provides comprehensive information and direct access to high quality CTUs across the UK which have achieved UKCRC Registration status. There are currently 48 UKCRC (UK Clinical Research Collaboration)-registered clinical trials units in the UK, 30 of which have full registration and 18 provisional, and in 2012 this registration status is under review and a new application process is underway.
Nearly one-third of the 48 UKCRC (UK Clinical Research Collaboration)-registered clinical trials units in the UK have selected MACROTM EDC to meet a requirement of their registration, which is to provide an appropriately and formally validated system for running clinical trials. Many of these CTUs have passed MHRA audits of their MACRO-based clinical trials.
MACRO meets all the following functional requirements of such a system, making it ideally suited to the needs of a UKCRC-registered CTU:
- MACRO has powerful, user-friendly study definition tools that allow for ultimate control and flexibility in study design
- MACRO has an easy-to-use, web-based electronic data capture interface, allowing remote investigator site staff to enter and edit data
- MACRO has robust and flexible data browsing functionality enabling CRAs to perform remote study monitoring, on-site source data verification (SDV), data freezing, and issuing of data clarification requests (DCRs)
- MACRO provides a range of Clinical Data Management (CDMS) capabilities, allowing users to query, clean, lock, report on their data, and export it in a variety of ways
- MACRO allows users to manage study safety protocols with confidence
- MACRO provides Randomisation using four methods and Clinical Coding (auto-encoding and manual coding) of adverse events using MedDRA
- MACRO includes other key modules such as Library Management, Events Management, and Batch Data Loading
- MACRO has full audit trail, individual user access management functionality and full back-up procedures
MACRO is also available to CTUs as a 'Software as a Service' (SaaS) study hosting service with our UK hosting partner Rackspace. This service minimises the effort required by the CTU to create a fully operational, validated installation of MACRO, as it offers:
- an easy validation process driven by experienced InferMed professionals
- an accelerated implementation schedule
- elimination of the need for investment in expensive dedicated server hardware and skilled support staff
- removal of the hassle of IT administration, maintenance, patching and back-ups
- a robust, powerful and secure IT infrastructure, as used by top blue-chip companies
- scalability assurance
InferMed also makes a range of services available to MACRO users:
- Design consultancy – specialist support is available in defining studies where required
- Study audit – expert review and analysis of study definitions providing recommendations for optimum study performance and EDC functionality utilisation
- Technical support – detailed support in the use of MACRO is available from our Technical Services team
- Testing – evidence of thorough testing and application version control
- Installation – trained InferMed engineers install MACRO at user sites and run full installation and operational qualification (IQ & OQ) tests to ensure the efficacy of the customer's installation
- Training – a range of introductory and advanced training courses is available to meet individual user needs
Server Specification or Server Performance Testing and Analysis – a three-day consultancy project to ensure that the customer’s hardware platform is optimised for peak performance.
InferMed offers introductory packages to support young and emerging CTUs in adopting both the licensed and SaaS models of MACRO. These packages are priced at levels that have already proven to fit within a typical CTU budget.
If you are a CTU going through the application process and seeking UKCRC registration, or you are having your UKCRC registration status reviewed and you need to obtain an appropriately validated system for running clinical trials at a highly competitive price for your unit, please contact us for further information and for a demonstration of MACRO v4, the latest version of our advanced EDC and CDMS application.