Adaptimmune chooses SCiAN Services’ EDC(PRO) solution
By Mia Burns (email@example.com)
SCiAN Services, Inc., a provider of clinical data management - biostatistics CRO and EDC solutions has announced that Adaptimmune has chosen selected SCiAN’s EDCPRO platform to manage its clinical trials. After a review of several EDC vendors and CROs, the companies reached a services agreement. Under the agreement, SCiAN will 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 using the EDMS extension. Associate Web Editor Mia Burns interviewed St. Clare Chung, Director, Biostatistics and Data Management at SCiAN Services.
Q: For those who are not familiar with your SAEPRO module, could you please provide a bit of background?
A: SAEPro is a fully integrated module of our EDCPro platform, deployed separately or in combination, based on sponsor requirements, and similarly managed on a hosted only basis or with full service support from SCiAN’s pharmacovigilance team. SAEPro enables the collection, validation, and reporting of serious adverse events in clinical trials and each database is customized and configured to the study in question. The safety databases and system platform enjoys the same level of regulatory compliance and third party audit inspection as EDCPro, ensuring conformity with industry and FDA standards. In addition, SAEPro has retained the same user-friendly interface, logical workflow process and ease of navigation that our user-base has come to value in EDCPro.
Q: Would you say that EDCPRO is like one-stop shopping for EDC?
A: Yes, that’s a straightforward way to summarize the comprehensive features and functionality of EDCPro. The sponsor can choose to manage all aspects of a typical clinical trial themselves or experienced SCiAN staff can provide a complete outsourced solution for managing the data and delivering associated biostats services for Phase I-III studies. Unique to EDCPro, is its support of virtual - small - medium size drug development companies - biotech and biopharma: beyond the standard EDC/eClinical functionality, EDCPro incorporates a powerful SOP engine to guide team member to complete their tasks, prioritizing and sequencing their work to achieve specific targets, such as delivering quality data for DSMBs, interim analysis on specific due date, etc.
Q: Could you please elaborate on your EDMS extension?
A: EDCPro enables the electronic capture and validation of data from the study site, while the EDMS extension facilitates the management of study/ regulatory documents (the trial master file, TMF) throughout the duration of the clinical trial, as a fully integrated module.
Q: About how many customers are on EDCPRO within the pharma industry?
A: SCiAN's CDMmanager and the EDCPro platform have supported the majority of SCiAN’s 650 studies completed since 1988. The EDCPro system was first developed 15 years ago and version 4 was released in 2012.
Posted: October 2013