Heading to Oracle CloudWorld 2024 in Las Vegas this week? Be sure to connect with Prashant Mathur and Abhijeet Balsaraf! Talk to us about partnering to support clinical trials, data management, reporting, Infrastructure as code, and security.
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CTIS welcomed our workforce back to the office earlier this month. We were excited to see everyone in person, and the happy faces and positive energy flowing through the office – plus cake!
Thank you to Mr. Omelette Caterers for brunch.
CIO Blaze Mathew was building on the momentum from AWS PartnerEquip in Washington DC last week! The Migration and Modernization track offered valuable insights into AWS solutions for tackling current and future challenges.
Contact Blaze if the following apply to your organization:
1. Do you run VMware workloads on-premise and would like to fast-track migration to AWS cloud?
2. Evaluate your Enterprise Application for a fast-track Application migration and modernization path to AWS cloud!
Benefits include:
*Increased agility for faster innovation,
*Scalability to meet growing demands and
*Cost-efficiency by optimizing resources.
Thanks to Amazon Amazon Web Services (AWS), Elamaran Shanmugam, and organizers for an enlightening experience!
AWSPartnerEquip MigrationAndModernization CloudInnovation DigitalTransformation
CTIS CEO Bharti Shah was awarded Patriotic Employer from the Office of the Secretary of Defense for her ongoing employer support of the National Guard and Reserves. Organizations such as CTIS who employ and recruit members of the National Guard and Reserves are key to supporting the U.S. Armed Forces, national defense, and readiness.
For more information, visit https://www.esgr.mil/
CTIS and its Health Policy Research Consortium (HPRC) provided leadership and informatics support to address disparities in health outcomes across population groups through policy studies and advocacy. The HPRC received funding from the National Institute on Minority Health and Health Disparities of the National Institutes of Health as a multi-million dollar cooperative agreement over 5 years, which recently completed its work.
Members of the consortium included community-based organizations, faith-based organizations, schools of public health, state public health departments and clinical partners to design and conduct research studies whose outcomes would inform public policy decisions. The HPRC served as a hub of scientific expertise and community insight, with a solid foundation of informatics developed and maintained by CTIS in support for the enterprise.
The Helene Fuld School of Nursing at Coppin State University with a focus on: The Health Policy Literacy Study (HPLS): Bridging the Gap between Community, Science and Policy, and Disadvantage in the Food, Built, and Social Environments: A Study of Cardiovascular Health (The CVD Study)
Selected Publications: Cardiovascular disease in the Nation’s Capital: How Policy and the Built Environment Contribute to Disparities in CVD Risk Factors in Washington, DC. J. Racial Ethnic Health Disparities, 2019, 6 (1): 46-55. Health Policy Responsiveness: Lessons Learned from Maryland and Prince George’s County. J. Racial Ethnic Disparities, 2017, 5(2): 366-374.
Challenge:
Jamaica and the Caribbean region are frequently affected by outbreaks of mosquito-borne diseases such as Chikungunya, Dengue, yellow fever, and Zika, as well as respiratory viruses like influenza and SARS-CoV-2. The University of the West Indies (UWI) plays a crucial role in monitoring these diseases through its National Influenza Center, but the region faces challenges in data management, analysis, and sharing among researchers. The growing need for real-time surveillance, cross-institution collaboration, and advanced data analysis required a scalable, secure, and accessible IT solution to support viral surveillance and research efforts.
Solution:
CTIS was selected as the cloud implementation partner to support the collaboration between SUNY Buffalo and UWI, expanding their viral surveillance program. Led by Dr. Gene Morse (SUNY Buffalo) and Dr. John Lindo (UWI), this initiative is backed by NIH’s Fogarty International Center. CTIS’s Chief Innovation Officer, Srikanth Uppalapati, leads the effort to migrate UWI’s virus surveillance data to the cloud, enabling enhanced analysis and collaboration across UWI campuses. By utilizing cloud infrastructure, the program ensures that researchers and trainees have access to a shared, secure computational environment to conduct advanced analyses and manage large datasets effectively.
This migration not only streamlines data management for viral surveillance but also provides invaluable hands-on experience for future leaders in medical virology, empowering them with cloud computing skills that are increasingly important in global health research.
Impact:
The migration of viral surveillance data to the cloud has accelerated research and improved the region’s capacity for monitoring and responding to viral outbreaks. UWI’s ability to conduct deeper analyses, in collaboration with other institutions, has been greatly enhanced, facilitating more timely and effective responses to epidemics. The project also strengthens the training program for virology researchers, equipping them with the necessary skills to manage data in cloud environments, which is essential for addressing future global health challenges. Through CTIS’s support, this initiative advances both the region’s viral surveillance capabilities and the development of a skilled workforce in medical virology.
The National Cancer Institute (NCI) faces a complex challenge in managing cancer clinical trials across more than 2,000 sites in the U.S. and internationally. Coordinating research, ensuring patient safety, sharing adverse event data, and streamlining regulatory processes are critical to advancing cancer therapies. Without an efficient and user-friendly IT platform, researchers would experience delays in trial design, protocol agreements, and data sharing, ultimately slowing the approval of new cancer treatments and therapies. The NCI needed a secure, scalable IT solution to support the Cancer Therapy Evaluation Program (CTEP) and the larger Cancer Trial Network.
For over 25 years, CTIS has been the leading provider of information technology services to the NCI’s CTEP-ESYS, the backbone of its Cancer Trial Network. CTIS developed and maintained over 25 software solutions that enable seamless collaboration among cancer researchers, allowing them to work on shared clinical trial protocols more efficiently. These solutions facilitate faster design and approval processes by providing a platform for real-time collaboration. CTIS also developed systems to share adverse event data securely across trial sites and with the FDA, ensuring that medical monitors and regulatory officials can make timely decisions about patient safety.
CTIS’s technology ensures that trial data is protected, particularly safeguarding patient information. Their comprehensive IT services, including software maintenance and development, play a crucial role in managing clinical trial activities and expediting the creation of New Drug Applications (NDAs) for drug approval.
CTIS’s long-term support of CTEP-ESYS has significantly accelerated the pace of cancer clinical trials, leading to faster drug approvals and quicker access to life-saving treatments for patients. Their solutions have improved collaboration across research sites, saved time in trial design, and enhanced patient safety through the timely sharing of adverse event data. As a result, CTIS has played a vital role in advancing cancer research and improving health outcomes. In 2022, CTIS received a $100 million contract under CIO-SP3 to continue supporting the program for another five years, demonstrating the sustained value and impact of their work.
The National Institute of Allergy and Infectious Diseases (NIAID) requires a robust IT infrastructure to manage its extensive clinical research agenda, particularly in infectious diseases. The agency faces the challenge of coordinating multiple programs, complying with federal regulations, managing large volumes of regulatory documentation, and streamlining information exchange across its diverse research efforts. Additionally, the NIAID Division of AIDS (DAIDS) needed specialized support for clinical trial management, regulatory tracking, and compliance, while balancing operational efficiency and cost-effectiveness.
CTIS, as a subcontractor to both Digital Infuzion and Technical Resources International, provided comprehensive IT and project management support to NIAID. CTIS’s contributions include maintaining NIAID’s Clinical Research Management System (CRMS) to facilitate seamless collaboration, data sharing, and regulatory compliance. By offering project management, program coordination, and federal records management, CTIS ensured that NIAID could efficiently manage the lifecycle of clinical trials and related regulatory activities. CTIS also developed and enhanced critical tools such as the Adverse Events Processing System and Protocol Registration, while supporting both legacy and modernized systems.
CTIS implemented a Digital Government strategy to harmonize data across NIAID’s internal and external collaborators, provided ongoing application security, and facilitated decision-making through business intelligence and analytics. Their approach encompassed software development, system maintenance, and compliance reporting, aligned with Agile and CMMI frameworks to ensure that security controls and operational efficiency were maintained at all times.
CTIS’s partnership with NIAID advanced the organization’s ability to manage clinical trials, streamline regulatory documentation, and comply with federal regulations more effectively. The enhanced Clinical Research Management System improved data exchange, facilitated collaboration, and reduced infrastructure costs. NIAID’s Division of AIDS benefited from new, custom-developed systems that replaced outdated infrastructure, enabling faster and more accurate tracking of clinical trials, regulatory submissions, and adverse event reporting. CTIS’s strategic IT solutions helped NIAID advance its infectious disease research agenda, ultimately supporting public health initiatives at the national level.
At CTIS, our team is deeply committed to advancing health decisions and increasing the efficiency of clinical trials through expert data management and analysis. Our collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP) has led us to develop specialized IT solutions that significantly enhance the way cancer trials are conducted. These advanced tools make it easier for researchers to collaborate, speed up the reporting of critical data, and simplify trial processes.
Clinical trials play a crucial role in advancing medical science and enhancing patient care. These well-structured studies test new treatments, medications, and procedures to ensure they are safe and effective. They transform laboratory discoveries into real-world treatments that can benefit many. Here’s a straightforward guide to understanding clinical trials and their importance.
Clinical trials are research studies designed to test new medical methods on people. These methods can include new drugs, medical devices, vaccines, or new uses for existing treatments. The main goal is to determine if these new methods are safe and effective for people.
Clinical trials are divided into phases, each with specific goals:
Participants join clinical trials through medical centers or clinics. They first receive detailed information about the study, including its purpose, procedures, risks, and benefits, and then consent to participate.
Participants are typically divided into groups. One group may receive the new treatment, while another group gets a standard treatment or placebo (a dummy treatment). This setup helps researchers compare the new treatment’s effectiveness and safety against the standard options.
During the trial, participants are closely monitored. Researchers collect data through tests, questionnaires, and physical exams to understand how the treatment affects them and to identify any potential side effects.
Clinical trials are essential for several reasons:
Clinical trials are vital for medical research and improving healthcare. They provide the evidence needed to develop and refine treatments. Understanding the phases and processes involved highlights the significant effort behind new treatments and their impact on medicine’s future. If you’re considering participating in a clinical trial, it’s important to consult with your healthcare provider to fully understand the potential benefits and risks.
At CTIS, we’re dedicated to making clinical trials and drug development better. Our hard work has been recognized with awards from esteemed organizations like the National Institutes of Health (NIH) and the National Cancer Institute (NCI). These awards underscore the real difference we’re making in research and treatment. By continually refining clinical trial methods, we help develop new therapies and improve health outcomes. Our mission is to significantly advance medical research, leading to more effective treatments and enhanced patient care.
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