14M Genomics is a cancer diagnostic company, based in Cambridge UK and working in partnership with The Wellcome Trust Sanger Institute, to enrich the understanding of the role of cancer genes in the biology of disease.
In March 2015, 14M Genomics (14MG) and the European Organisation for Research and Treatment of Cancer (EORTC) announced a collaboration to use genomic diagnostic profiles on solid tumour samples, to facilitate patient enrolment into next generation cancer clinical trials.
Supported by a network of over 30 clinical centres in 11 countries, this initiative has the ultimate goal of enabling better access to new treatment options. Between 600 and 1000 patients with advanced colorectal cancer are expected to enrol each year.
To facilitate the dissemination of the resulting Patient Test Reports (PTR), 14MG commissioned Tier 2 Consulting to build a highly secure web portal for participating clinicians across Europe to retrieve and download PTRs in PDF format.
The RAPHAEL portal (Reporting Advanced Patient Healthcare Analysis, Evaluation & Learning) went live in September 2015.
RAPHAEL is based on Tier 2’s ARENA Web-based Document Control System using standards-based JEE and open-source middleware technologies. ARENA is a product of over 10 years experience of delivering document control solutions in the pharmaceuticals and insurance sectors.
To create RAPHAEL, ARENA was configured to meet specific requirements, for example to include support for multiple languages and the 3-stage 14MG / EORTC approval process required to make PTRs accessible by clinicians.
Once all necessary approvals have been given, clinician users are able to search for, retrieve and view published PTRs that match their Centre Affiliation. RAPHAEL supports not only structured keyword searching, but also searching of the content of the PTRs themselves.
Commenting on the successful build and deployment of the RAPHAEL web portal, Fionnuala Patterson, Director of Bioinformatics at 14M Genomics said:
“Tier 2 Consulting came highly recommended for this project and the depth of their sector knowledge became apparent from the outset. We were delighted to find that the native ARENA product met the bulk of our requirements for RAPHAEL – and that Tier 2’s customization skills could shape the final system specification.
The final specification for RAPHAEL was evolved to accommodate specific audit trail functionality, based on Tier 2’s guidance and expert knowledge of computer system validation and their detailed knowledge of FDA 21 CFR Part 11 regulations.
As such we have created a compliant environment and a highly secure portal for participating clinicians across Europe. With over 250 PTRs now live within the RAPHAEL repository since launch we are providing EORTC partners with a tailored web based service to facilitate timely patient enrolment into clinical trials for new cancer treatments.
We are delighted with that outcome and the work delivered by Tier 2 Consulting.”
About 14M Genomics
14M Genomics aims to become a European leader in the provision of clinical genomics services and clinical decision support tools, which will inform the diagnosis, prognosis and treatment of cancer. The company employs state-of-the-art sequencing and analytical tools, coupled with an in-depth understanding of cancer biology, to reveal associations between tumour genomics and the clinical path of the individual patient. 14MG aims to work together with the oncology community, academic institutions and pharmaceutical partners to improve the lives of cancer patients.