Our Capabilities

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Our Capabilities

CTIS, Inc. is a Women Owned Small Business (WOSB) based in Rockville, Maryland with over 30 years of experience delivering Health IT solutions to clients in support of clinical trials and research. We are a leader in developing innovative solutions that leverage data management for the health and human services industry across research, healthcare, and public health domains. 

We are a leading provider of health informatics solutions, with decades of experience partnering with clinical trial and research stakeholders. We thrive in the key role of managing data that drives missions and supports the work that delivers drug development processes, cycles, and ultimately cures. We strive to capture, store, and analyze health data to support informed decision-making. CTIS is a proven solutions integrator in data security, threat detection and user experience optimization. We specialize in custom-tailored IT solutions for government agencies, universities, hospital systems, and other healthcare organizations, helping them optimize their data management and IT infrastructure.

Clinical Trial Informatics

Mission Modernization

Infrastructure Optimization

Our Capabilities

Clinical Trial Informatics

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.

Corporate Responsibilities

Mission Modernization

Best practices support agile development and tailored master data management solutions for our customers working in highly sensitive and exacting data environments. In addition to our work with CTEP, CTIS also assists clients in modernizing their IT infrastructure as part of their digital transformation journeys. Our capabilities include managing and optimizing critical infrastructure, 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.

CTIS offers a competitive edge and comprehensive suite of services that span the entire clinical trial lifecycle:

Proven leaders in healthcare informatics:

  • Cross functional team formation based on client IT environment with the ability to scale and deliver complete features with minimal dependency​
  • Inclusiveness by embedding the client into roadmap development, epic and feature prioritization, and delivery ceremonies such as PI and Sprint planning, Scrum, Demonstrations and Retrospectives, and Inspect and Adapt.​
  • Transparency into planning and delivery with clients using the same Dashboard metrics as the Project Team​
  • Optimal throughput in work quantity delivered through fixed cycles.​

Trial Planning:

  • Protocol development across multiple sites
  • IRB management
  • Network and site data interchange

Trial Activation:

  • CRF designer
  • Regulatory support
  • Clinical development planning
  • Site, patient, and investigator registration

Trial Conduct:

  • Patient accrual management
  • Data abstraction
  • Protocol change management
  • Drug management and delivery
  • Site monitoring and auditing

Trial Reporting:

  • Research outcome analysis
  • Research dashboard monitoring
  • Expedited and non-expedited adverse event reporting
  • E-submissions to the FDA

Through our award-winning IT platforms and solutions, CTIS is committed to improving clinical trial operations, enhancing regulatory compliance, and driving greater efficiency and productivity in health research. The result? We accelerate the delivery of life-changing therapies to patients worldwide.

Infrastructure Optimization

Cloud computing is transforming how government and healthcare sectors manage infrastructure, enabling streamlined access to servers, storage, software, and data with unmatched flexibility and scalability. For organizations navigating unique compliance requirements, CTIS offers secure, cost-effective,hybrid and tailored cloud solutions that adapt to mission-critical needs. Our expertise spans the three core cloud service models—Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS)—to help government and healthcare clients optimize their operations.

Key Benefits for Government and Healthcare:

  • Security & Compliance: CTIS ensures that all solutions comply with government regulations and industry standards, addressing strict security requirements for data protection and patient privacy.
  • Scalability & Flexibility: Our cloud infrastructure supports rapid scaling, providing on-demand resources for organizations facing fluctuating workloads and enabling quick response to operational changes.
  • Cost-Efficiency: CTIS’s cloud solutions are designed to reduce infrastructure costs through pay-as-you-go models, allowing budget-conscious clients to focus on essential services while only paying for what they need.
  • Flexibility & Strategy: CTIS identifies right-fit solutions that adapt for customer needs today and into the future including containerization, virtualization, provisioning, migration, and infrastructure operations.

CTIS Cloud Solutions

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.

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.

IT Infrastructure Support

CTIS delivers advanced IT infrastructure support designed specifically for clients in clinical trials research, federal agencies, and commercial sectors. With a proven track record, 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.