TORONTO, Feb. 12, 2013 /PRNewswire/ - SCiAN Services, Inc., a North American Clinical Data Management - Biostatistics CRO and EDC solution provider announces that Adaptimmune has selected SCiAN's EDCPRO platform to manage its clinical trials starting in 2013. Following a review of several EDC vendors and CROs a services agreement was executed with SCiAN to deliver a comprehensive systems and services solution for Web-based data capture and data management, including pharmacovigilance using the SAEPRO module and integrated electronic record management of trial master files (TMF) using the EDMS extension.
SCiAN's systems will support Adaptimmune's novel T cell therapy clinical trials by providing a comprehensive EDC, data management, pharmacovigilance and TMF solution. "In addition to the SCiAN staff's responsiveness and knowledge in oncology, Adaptimmune's Clinical Team was impressed by the user-friendly interface of EDCPRO compared to other EDC systems evaluated. We were especially pleased with the ability to dynamically update and control user views and upload 3rd party data, such as lab data and site documentation - Word and PDF documents - as well as the ability of the standard and ad hoc reporting module, which is a real asset for both data management and site monitoring activities," said Dr. Gwen Binder-Scholl, Executive Vice President, Adaptimmune, LLC. She added, "SAEPRO and SCiAN's services for pharmacovigilance were also essential elements in the decision and will allow us to seamlessly record and report data to regulatory authorities."
EDCPRO has elevated the scope of what is now possible within EDC trials. "With EDCPRO, Adaptimmune will have complete control over their data, principally due to the rigorous communications, tracking and control features that have garnered praise among our user base", said St. Clare Chung, Director, Biostatistics and Data Management. She went on to add, "Investors and drug developers today are extremely risk averse when it comes to their clinical development programs and partners. The transparent functionality and data quality analytical tools that are resident in EDCPRO are just two key features that enable sponsor oversight to maintain data quality and integrity and prevent cost overruns and loss of time."
Adaptimmune is focused on the use of T cell therapy to treat HIV and cancer. It aims to utilize the body's own machinery - the T lymphocyte cell - to target and destroy cancerous or infected cells.
Established in July 2008 with a research base in Oxford, UK and clinical base in Philadelphia, US, Adaptimmune was set up to a develop unique T cell receptor engineering technology for adoptive T cell therapy exclusively licensed from Immunocore Ltd (formerly Avidex/MediGene). Specifically, Adaptimmune makes use of the body's ability to recognize infected or cancerous cells by enhancing the power of the T cell receptor (TCR) on killer T cells. All cells, including cancerous cells, will typically present small parts or peptides of internal proteins on their surface as part of the natural protein processing pathway. This offers a "molecular fingerprint" of the protein called an epitope for killer T-cells from the immune system to identify and destroy. However, since cancer proteins are usually derived from self proteins against which naturally selected TCRs in the body do not respond, the Adaptimmune technology uniquely enhances the natural TCR affinity to these cancer-specific epitopes enabling targeted killing of the cancer cells.
Adaptimmune has undertaken significant preclinical development with a number of pipeline TCRs to demonstrate their potency and specificity in vitro. The TCR in the current myeloma study specifically recognizes two cancer testis antigen targets: NY-ESO-1 157-165 and LAGE-1 (HLA A2; SLLMWITQC), and was engineered using Adaptimmune's proprietary TCR engineering platform. Myeloma is the lead indication for the therapy, with related trials in melanoma and sarcoma also recruiting patients and further trials in ovarian and hepatic cancer scheduled to open in 2013. http://www.adaptimmune.com
SCiAN Services is a North American leading Clinical Data Management - Biostatistics - Pharmacovigilance CRO and EDC solution provider. Drug developers (Biotech/Biopharma, and pharmaceutical companies) rely on SCiAN's 27 years of experience in IND stage clinical trials phases I-III. SCiAN's therapeutic area expertise developed in over 650 clinical trials includes oncology, CNS, infectious diseases, inflammatory / autoimmune diseases, diabetes, etc. The company's service depth is further backed by its industry renowned EDCPRO platform, custom developed for small to medium size drug development companies and their CROs.
SOURCE SCiAN Services, Inc.