Press Release

C3i Industry Experts to Present at the Oracle Health Sciences User Group Conference (OHSUG) in Monte Carlo, Monaco

Monaco – November 4, 2012

C3i Inc, the leading provider of technology support and business process outsourcing (BPO) services for the life sciences industry, announced that C3i industry experts will deliver 5 presentations throughout the Oracle Health Sciences User Group (OHSUG) in Monte Carlo, Monaco, 4-7th of November, 2012.

All attendees will be able to meet C3i’s experts at booth 215 during the conference!

Monday, November 5th

- Presentation : Technology Support and Provisioning for Clinical Trials in APAC
- Presenter: Warren Ryanes - Director, Asian Operations
- Time: Monday November 5th - 3:00 pm - 4:00pm

Description: The growth in clinical trials in APAC countries continues to be significant. Market, cultural and language differences in countries as diverse as China, Japan, and Korea result in a challenging support environment. Do you understand the technology support needs of these emerging APAC markets? Learn how to meet these challenges with data and quantitative examples from leading sponsors and CROs. This session will focus on multilingual technology support of Oracle systems, including technical provisioning of sites.

- Presentation: Improving Patient Adherence in Clinical Trials
- Presenter: Kathy Zonca, Consultant
- Time: Monday, November 5th - 3:40 pm - 4:00 pm

Description: Patient adherence has been described as the “other” drug problem in routine clinical practice. But is it an issue in clinical trials where one expects the patients to be more highly motivated to adhere? This presentation will discuss the issue of non-adherence in clinical trials. It will explore reasons that adherence might be lower than desired in trials and how non-adherence can impact clinical research results. The presentation will also look at other closely related areas of concern that can impact the integrity of trial data and finally will offer some suggestions for ways to improve patient adherence in the clinical trial setting.

Tuesday, November 6th

- Presentation: Industry Survey: Global Trends and Experiences with Software-as-a-Service Applications for Clinical Data Management
- Presenters: Kevin Shea, Senior Clinical Solutions Director
- Time: Tuesday, November 6th, 9:30 am-10:00 am

Description: Advances in technology and the maturation and availability of high bandwidth networks are driving migration of the installed location of various applications from on-premise in corporate data centers to centralized off-premise sites managed by vendors. Systems that serve non-CDM markets are well-established in software-as-a-service (SaaS) models, providing users with lower and more predictable costs. To date, clinical data management (CDM) tools have had mixed success gaining acceptance in the user community. To better understand the user community&rsquo’s attitudes around SaaS CDM tools, we conducted a set of peer surveys to clarify the factors that drive user acceptance and satisfaction with these tools, and contrast the concerns with on-premise to SaaS systems. The respondent set is a geographically diverse group of experienced clinical professionals (CDM workers) who utilize a full-range of CDM tools, including EDC, CTMS, TMS, and safety systems. The respondents work at sponsors, CROs, and other life sciences organizations. The survey sought to clarify the factors that may impact the transition to and acceptance of SaaS CDM models. We surveyed the overall satisfaction with current data management systems and to what degree people would like to change or improve factors such as data quality, data reports, investigative site adoption, reliability, ease of validation, and security. We will reveal the expectation of users about benefit they foresee for their clinical operations by implementing a SaaS tool. The following areas of operations will be discussed: systems integration, training, user support, security data quality, extracts, data query handling and site monitoring, system update, and usability. The data we present will guide improvement in on-premise and SaaS CDM applications and focus CDM organizations that contemplate the migration from on-premise to off-site.

- Presentation: Clinical Investigator Portal Innovation and Support Profile
- Presenter: Kevin Shea-Senior Clinical Solutions Director
- Time: Tuesday, November 6th, 11:15 am - 12:15 pm

Description: Clinical Investigator Portals can be an innovative and useful entry point for study trial participants. Some portals are more robust and complex than others. Is there a correlation between the depth and complexity of a Client Investigator Portal and the number and type of Support Requests? Is there any value in having a portal that offers a significant amount of tools and features, or does added features create more support issues? The purpose of this presentation is to take an investigative look at several Clinical Investigator Portals and compare and contrast the associated technology related issues. Finally some opinions will be drawn from the data collected and recommendations will be made for best practices.

- Poster Presentation: Managing End User Communication and Feedback
- Presenter: Kevin Shea –Senior Clinical Director, Sara DiMinno-Project Manager
- Time: Tuesday, November 6th, 12:30 pm - 1:30 pm

Description: Effective end user communication is a key to customer satisfaction in any business; however it is critical to the successful implementation and utilization of clinical trial technology solutions. Successful communication with end users helps to ensure data quality, timeliness, and adherence over the life cycle of a study. Strategies must place focus on both proactive and reactive modes of communication to ensure end users, such as site coordinators, PIs, monitors, and subjects, are fully supported and informed. Such a comprehensive strategy for end user communication is not a simple undertaking. Key factors to consider are: the method, timing, content of the communication, as well as the priority of the information communicated. Key questions to consider include: are you communicating a change that is crucial to the end user?
Are you setting expectations that must be completed by the end user? Understanding that information comes from different vendors and is communicated in different methods (such as-Mail, Phone, Web) is also crucial to successfully setting the right expectation with the user. Global communication is another important aspect, in which managing communications to/from users in different time zones, with different language competencies, and cultural practices can be challenging. Lastly, providing an effective means for users to provide feedback to you and facilitating timely responses to them—during their working hours can also be difficult to implement successfully. Our presentation we will review these challenges and provide best practices that we have developed as a Support Partner in hundreds of clinical studies, as well as some of the ways we have developed to measure and monitor successful communication and customer feedback.

About C3i:
Headquartered in Morristown, New Jersey, C3i Inc. has global operations centers in North America, Europe, India and China. Their 1400 employees provide technology training, multi-lingual service desk, hardware provisioning, and break/fix, asset management, and user/application administration services for pharmaceutical sales and clinical professionals worldwide. To learn more, visit us at www.c3i-inc.com  and follow us on Twitter http://twitter.com/#!/C3i_Inc