CTIS has been a trusted leader in delivering comprehensive informatics solutions for clinical research, offering specialized expertise in clinical research enterprise solutions, safety reporting & monitoring, health data standards, and privacy and security solutions. Our extensive experience spans across multiple domains, including oncology, AIDS, hematology, cardiology, pulmonary, and critical care, allowing us to address the unique
challenges and evolving scientific needs in each field.

Clinical Research Enterprise Solutions: CTIS provides end-to-end clinical trial informatics solutions that enhance trial design, management, and analysis. Our enterprise IT solutions integrate complex, evolving science such as biomarkers, genomics, and precision medicine trials, while ensuring real-time data sharing across disparate systems. This improves data quality, streamlines regulatory compliance, and enhances transparency—all key to modernizing clinical research infrastructure.

Safety Reporting & Monitoring: CTIS excels in developing and implementing robust safety reporting systems that meet rigorous regulatory standards. We enhance the control, transparency, and monitoring of trial data, ensuring that adverse events and safety concerns are tracked, reported, and mitigated in real time to safeguard patient well-being and study integrity.

Health Data Standards: We understand the critical importance of health data standards and compliance in clinical research. CTIS uses single-source data entry and standardized protocols to ensure interoperability and data quality across various platforms. This approach minimizes redundancy, enhances data reusability, and ensures that research teams can confidently rely on consistent, high-quality data throughout the lifecycle of a clinical trial.

Privacy and Security Solutions: CTIS takes a proactive approach to ensuring the privacy and security of health data. We provide scalable, secure IT infrastructures that comply with industry standards, safeguarding sensitive patient information and clinical data. Our privacy solutions ensure that all information is handled with the utmost security, meeting the compliance requirements of governing bodies.

Proven Track Record: CTIS has successfully supported clinical trial informatics projects for prestigious institutions, including NIH’s National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), National Heart, Lung, and Blood Institute (NHLBI), and Inova Health System. Our solutions are built on a foundation of collaboration, trust, and a deep understanding of our clients’ business needs.

With deep expertise and innovative informatics solutions, CTIS is committed to driving clinical research forward, supporting life-saving health research goals, and advancing the future of medicine.

CTIS leverages its in-depth expertise and experience as a leader in providing Clinical Informatics solutions and implementing Artificial Intelligence/Machine Learning (AI/ML) methodologies to improve clinical trial management processes. We infuse AI/ML capabilities that help identify data anomalies and analyze historical and publicly available data to generate relevant patterns and provide recommendations for research reviewers and investigators that prevent errors, ensure compliance, and help expedite review and approval processes.

CTIS collaborates with customers to deliver rapid response solutions, implementing smart AI RAG-based LLM chatbots and other applications for our federal customers that bring critical information to their fingertips to consolidate and provide information and build context. AI and ML radically improve review processes, reducing exhaustion and manual labor, supporting protocols, and automating interpretation and analysis. In addition, support AI enabled document generation to reduce development time and provide highest level of quality and performance.

With deep experience across public, private, and hybrid cloud environments, CTIS integrates leading cloud providers, including Amazon AWS and Microsoft Azure. We specialize in comprehensive migrations, from email and SharePoint services to standby site configurations for enhanced resilience, leveraging Oracle and MySQL databases, Windows and Linux servers, and Office 365 environments. 

Cloud computing revolutionizes accessibility to servers, storage, applications, software, and data over the Internet. It offers a dynamic infrastructure platform with tailored costs, providing unprecedented flexibility and scalability. CTIS specializes in leveraging the three primary service models: IaaS (Infrastructure as a Service), PaaS (Platform as a Service), and SaaS (Software as a Service).

Advantages and Considerations:

While cloud computing presents numerous advantages, questions arise about its cost-effectiveness, security, reliability, and compliance with government laws. CTIS addresses these concerns, guiding you through a seamless journey to the cloud.

CTIS Cloud Expertise:

We possess extensive experience managing public, private, and hybrid cloud environments. Our solutions, hosted on Amazon AWS and Microsoft Azure, encompass Oracle and MySQL database services, Windows and Linux servers on EC2 (Elastic Compute Cloud), development environments, and the Office 365 productivity suite. CTIS excels in migrating email and SharePoint services to the cloud and implementing standby sites for enhanced resilience.

Cloud Integration Strategies:

Our cloud integration strategies prioritize seamless collaboration with on-premise authentication and authorization services. We ensure secure site-to-site connectivity, enhancing the overall integration of cloud-based resources.

Certified Expertise:

CTIS takes pride in having trained and certified staff for AWS and Azure in both business and technical areas. Our team’s expertise ensures the efficient utilization of cloud resources and adherence to industry best practices.

Cloud Capabilities

• Expertise in managing public, private, and hybrid cloud environments
• Proficiency in the three primary cloud service models: IaaS, PaaS, and SaaS
• Experience with cloud hosting on Amazon AWS and Microsoft Azure O365
• Specialization in Oracle and MySQL database services, Windows and Linux servers on EC2, development environments, and Office 365

Proven track record in migrating email and SharePoint services to the cloud

• Implementation of standby sites for enhanced resilience. 
• Seamless integration with on-premise authentication and authorization services. 
• Secure site-to-site connectivity for optimized cloud resource utilization
• Trained and certified staff for AWS and Azure in both business and technical areas, ensuring expertise in cloud management and implementation.

Expertise and Certifications

Our certified AWS and Azure professionals bring extensive technical and business expertise, ensuring secure and efficient cloud resource management. CTIS’s cloud integration strategies seamlessly connect cloud resources with on-premises systems for secure, collaborative solutions that enhance mission success.

CTIS’ best practices support agile development and tailored master data management solutions for our customers working in highly sensitive and exacting data environments. With past performances across federal agencies, academic institutions, and hospital systems, CTIS also assists clients in modernizing their IT infrastructure as part of their digital transformation journeys. Our capabilities include managing and optimizing critical infrastructure, Test, RPA, DevSecOps, Cybersecurity, migrating datasets to the cloud, conducting data analytics and visualization, and advising on system-wide architecture. Our expertise in developing web-based capture, reporting, and monitoring solutions, including ontology-powered analytics tools, empowers researchers to design and conduct studies more effectively, reducing the time to bring life-changing drugs to market.

Software development is an essential service that we provide to our federal and commercial clients. We help clients achieve their business goals by delivering effective IT enterprise architecture solutions. Our capabilities focus on facilitating automation, developing user interface, device integration, systems integration, and information exchange. We excel in our technical innovation while adhering to privacy standards and maintaining regulatory compliance. We have successfully deployed small applications to large-scale enterprise systems, providing innovative, cost-effective, scalable, secure technology solutions. Our metric of success remains exceeding client expectations with each engagement.

Capabilities

• Service Oriented Architecture (SOA) Web Services
• Enterprise Service Bus (ESB) and Messaging
• Single Sign-on (SSO) solutions
• MS Development – .Net C#, VB, SharePoint,
• Java Development – Core Java, JSP, JSF, Struts, Spring, Java/Java 2 Platform Enterprise Edition (J2EE) and Microsoft Practices development
• Other Open-Source Development – PHP, Perl
• Database Platforms – MS SQL Server, Oracle, MySQL, DB2
• Document/Content Management Solutions – MS SharePoint, OpenText, Documentum, Laserfiche
• Regulatory Compliance – Section 508, 21CFR Part 11
• Data Standards – BRIDG, HL7, and CDISC
• Agile ALM Methodologies – Scrum and Test-Driven Development
• Quality Assurance Standards – CMMI for Services Level 3, HHS EPLC, ISO 9001:2015
• Management standards – PMBoK, EVM

CTIS delivers advanced IT infrastructure and security support designed specifically for clients in clinical trials research, federal agencies, and commercial sectors. With a proven track record of managing various client needs, CTIS optimizes infrastructure to align seamlessly with clients’ strategic research and operational goals, offering highly reliable hosting solutions that support mission-critical applications and data.

Key Differentiators in IT Infrastructure Services:

• High-Availability Configurations: CTIS specializes in creating robust, high-availability systems, including clustered database servers, network load-balanced web servers, and real-time replication solutions to maximize uptime and ensure data accessibility.
• Advanced Backup & Recovery: Our infrastructure designs prioritize rapid recovery, establishing optimal recovery points and times that align with client needs. Annual disaster recovery simulations and contingency tests help our clients stay prepared for a range of scenarios.
• Certified Expertise & Standards Compliance: With a team averaging 10+ years of experience, CTIS staff hold certifications such as CCSP, CISM, CCNA, MCSE, OCP, and ITIL v3, ensuring deep expertise in both security and infrastructure management. Our approach follows the NIST security framework and HHS-adopted NIACAP, guaranteeing rigorous standards compliance.

Operations and Maintenance Excellence

CTIS’s IT Service and Help Desks deliver proactive infrastructure management through a hybrid model that emphasizes security and efficiency. Our team oversees all aspects of IT operations, maintenance, and help desk support, minimizing downtime and ensuring infrastructure resilience.

Comprehensive Capabilities

• Advanced Computing Environment: Optimized data center hosting, consolidation, and management
• IT Systems & Network Management: Encompassing application, web, and database services
• Information Assurance: Focused on confidentiality, integrity, and availability of data
• Regulatory Compliance: Ensures adherence to stringent industry standards
• Virtualization & Cloud Solutions: Infrastructure virtualization and cloud services across servers, desktops, and applications to increase agility and scalability

CTIS’s tailored IT infrastructure solutions enable clients to leverage a stable, secure, and scalable environment, supporting their research and operational needs with excellence and reliability.

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.

Government organizations trying to modernize their IT support systems must comply with myriad security and regulatory requirements all the while they are trying to improve services for users and reduce cost. And with the different functional groups involved – Operations, Information Security, Development – the result can be chaos.

DevSecOps is as much a people and culture shift as it is a methodology that makes organizational objectives, applications development, and infrastructure security a shared responsibility of all.

Based on underlying Lean, Agile, and DevSecOps Principles, CTIS’ s SAFe methodology has proven successful in offering enhanced user experience, accelerated schedules, reduced costs and integrated software that is stable and compliant to government policies. Our DevSecOps processes and tools also facilitate continuous reauthorization (ATO) by automating required security steps throughout the software development lifecycle and continuously providing security teams with the insight to judge whether a system is worthy of deployment.

And so, when the different functional groups are involved the results are very different – efficient development, secure systems, minimal disruption and satisfied end users.