Programs

1. About IT Support:
   The ICERMALI IT support team provides data management and network services for ICER Mali customers with on-site and remote operations. They specialize in support for accurate data collection, management, and validation. Their extensive experience in clinical trials and biomedical research give them a unique skillset for corporate communications and data integrity.

2. IT Services:
   A-) Bioinformatics and Data Science Support
   Recently, the IT team has been working on developing data warehouses for clinical research data to improve the analytical options for researchers and data managers. These data warehouses use open-source software to create tools that data managers and statisticians can use to integrate genomics, demographics, and clinical data to speed analysis and validation. These systems also provide useful tools for monitoring the status of the clinical trials and studies to ensure that operations are meeting the objectives of the protocol. They have also worked to develop public private partnerships between industry, academia, and governments to build computational infrastructure in developing countries where access to these tools is more difficult. These solutions leverage the experience the IT team has accumulated working in these regions to optimize low-power reliability, lack of desktop infrastructure, and connectivity problems.

B-) Video Conferencing and Tele-learning
The IT team has been involved in supporting video conferencing, Voice over IP, and tele-learning solutions since its creation in 2004. These are an integral part of scientific collaboration and help keep teams working together despite great distances. They have studied the science of designing rooms for distant communication to optimize them for lower echo, light temperature for all skin tones, and wall color to improve definition. They also carefully structure solutions that will work in regions with unreliable power, low internet connectivity, and a lack of support staff.

C-) Identity Management for International Collaborations
One of the critical areas of research is providing identity management for scientific institutions. Organizations need to provide a verified identity to collaborators that can be trusted for accessing scientific tools used for research protocols. The IT team is working with the US-based Internet2 InCommon and the European-based EduGAIN to provide working identity federation for researchers at laboratories in Africa and Asia. This will provide researchers at those institutions with greater ability to collaborate using new tools such and virtual organizations such as the ELIXIR project in Europe.

D-) Data Center Design and Operations
To support larger scientific research facilities in remote regions, the IT team has built small data centers that provide local computing and storage capacity. This is necessary when local internet connections provide unreliable and low-capacity connectivity to remote data centers at collaborating or sponsoring research institutions. At these locations, the IT team operates the full range of network infrastructure and services, including wireless networks, wired networks, microwave inter-site links to metropolitan or campus facilities, disaster recovery solutions, information technology service management tools and training, as well as a monitoring and alert system. They assist collaborating institutions in developing best practice guidelines and information technology policies. They often provide operational assessments and audits for sites with recommendations that can integrate their understanding of clinical data management regulatory frameworks.

E-) Field Site Internet Access and Management
The IT staff have worked in Africa since 1998 developing solutions to connect laboratories and clinical sites to the internet for reliable communication and collaboration with international research institutions. They have a keen understanding of the scientific need of the research community and can tailor the best solutions to local contexts for activities planned or underway. They provide reports of the type of traffic from the site that is using the internet connection to reduce the impact of frivolous or non-work-related activity. Optimizing internet use for science activities requires more than just providing bandwidth. They provide comprehensive solutions that include antivirus/antimalware protection and patch management for leading applications and operating systems. Some remote regions of the world have severe problems with computer viruses that dramatically impact the performance of internet connections as well as putting the integrity of the data at risk.

F-) Biobank/Freezer Repository Services
The IT team uses integrated solution to support remote freezer repositories in Africa, South Asia, and China. They monitor the temperature and deliver tiered alerts to local staff with escalation to global supervisors if necessary. They install local SMS texting gateways in addition to email alerts. The systems are validated and fully 21CFRPart11 compliant. The information about tissue samples, vaccines, or drugs stored in these repositories uses a fully compliant commercial database that researchers and technicians can access over the internet, print labels, and use bar code scanners.

G-) Clinical Data Management Services
The IT operates a fully 21CFRPart11 compliant clinical data management system. They provide a full range of services to support this system for research protocols including reporting and statistical analysis, case report design, ongoing data management, and data entry services. They can support different service models for a range of needs, for example, investigators with experienced data management staff can use the system as a managed service using IT only for training and support. They can also provide a full suite of Clinical Data Management services for Investigational New Drug (IND) and observational studies. The IT team has extensive experience, and its data management system can support a wide range of data entry methods from mobile devices capture (using tablets), Electronic Data Capture (EDC), and traditional paper. The DataFax server on which its service runs is a mature clinical system that has been in use for clinical trials since 1990.

H-) Mobile Data Collection
Mobile devices such as smart phones and tablets promise to revolutionize many aspects of healthcare and clinical research beyond merely providing a form or remote capture device. Few studies have fully utilized the capability of these systems to improve the quality of data and protect the safety of clinical study participants. They work with the National Institute of Allergy and Infectious Diseases (NIAID) to develop a system for collecting clinical study data at field sites in rural India using tablets maintaining full compliance with 21CRFPart11 and Good Clinical Data Management Practices. In addition, they developed a solution for managing a global network of tablets over the internet to provide many of the services that a local institutions network provides such as user account management, antivirus, patching, updating of applications and clients for clinical data management systems.