Recently RDCT has been working to develop data warehouses for clinical research data to improve the analytics 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 operation is meeting the objectives of the protocol. We 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 that RDCT has accumulated working in these regions to optimize for low power reliability, lack of desktop infrastructure, and connectivity problems.
RDCT has been involved with support for video conferencing, Voice over IP, and tele-learning solutions since our founding in 2004. These are an integral part of scientific collaboration and help keep teams working together despite great distances. We 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. We also carefully structure solutions that will work in regions with unreliable power, low internet connectivity, and a lack of support staff.
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. We worked with 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, we 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.
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. RDCT is working with the Internet2 InCommon and the European based EduGAIN to provide working identity federation for researchers at laboratories in Africa and Asia. These will provide researchers at those institutions with greater ability to collaborate using new tools such as virtual organizations such as the ELIXIR project in Europe.
To support larger scientific research facilities in remote regions RDCT 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 RDCT 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 monitoring and alerting. We assist collaborating institutions in developing best practice guidelines and information technology policies. We often provide operational assessments and audits for sites with recommendations that can integrate our understanding of clinical data management regulatory frameworks.
RDCT staff have worked in Africa since 1998 developing solutions to connect laboratories and clinics to the internet for reliable communication and collaboration with international research institutions. We understand the needs of science and can tailor the best solution for the location and activities planned or underway. We provide ongoing 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 the science activities requires more than just providing bandwidth. We provide a comprehensive solution that includes antivirus/antimalware protection and patch management for leading applications and operating systems. 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.
Our company uses integrated solution to support remote freezer repositories in Africa, South Asia, and China. We monitor the temperature and deliver tiered alerts to local staff with escalation to global supervisors if necessary. We 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.
RDCT operates a fully 21CFRPart11 Compliant clinical data management system. We 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. We 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 RDCT only for training and support. We can also provide a full suite of Clinical Data Management services for IND and Observational studies. Our team has extensive experience and our data management system can support a wide range of data entry methods from mobile devices capture (using tablets), EDC, and traditional paper. The DataFax server on which our service runs is a mature clinical system that has been in use for trials since 1990.