Adaptive Clinical Infrastructure
Bridging the gap between validated standard software and the unique protocol needs of clinical sponsors, contract research organizations (CROs), and academic institutions.
Capabilities Overview/Clinical technology | Software engineering
Clinical Technology Experts & Specialized Software Engineering
Bridging the gap between validated standard software and the unique protocol needs of clinical sponsors, contract research organizations (CROs), and academic institutions.
For over three decades, CISYS LifeSciences has delivered software for regulated clinical research. Our proprietary Sequence Platform provides the foundation, while our consultative approach helps study teams address requirements beyond standard configurations. Dedicated clinical engineering resources evaluate trial needs, resolve workflow challenges, and develop tailored solutions.
30+ Years
Clinical systems experience
GxP Focus
Validation & data integrity
Protocol-Specific
Configuration & engineering
A Solutions-First Engineering Approach
Standard software can place limits on complex clinical designs. CISYS works as a technology extension of study teams, combining proven platform modules with engineering support throughout the development lifecycle.
Comprehensive Trial Discovery
Our engineering leadership works directly with clinical operations to evaluate data intake from multiple sources, specialized endpoint criteria, central laboratory imports, and site workload before deployment.
Rapid Protocol Adaptation
From voting algorithms for rare disease studies and multi-panel consensus rules to external application programming interface (API) integrations, CISYS configures and develops solutions around your protocol and clinical charter.
The Sequence Platform
Custom solutions build on the established Sequence Platform, supporting efficient implementation and documented validation for the intended use.
WebEAS
Core Functional Scope
Centralized endpoint adjudication
Customization Options
Multi-level voting rules, independent panel reviews, automated review packages, and real-time consensus logic.
WebPatient
Core Functional Scope
Subject eligibility and enrollment
Customization Options
Qualification workflows to support review of complex inclusion and exclusion criteria before randomization.
WebCode
Core Functional Scope
Standardized medical coding
Customization Options
MedDRA and WHODrug dictionary integration, automated term matching, and specialist review queues.
WebFXP
Core Functional Scope
Secure communication and document exchange
Customization Options
Role-based document delivery, safety letter distribution, and collaboration among study stakeholders.
WebFormX
Core Functional Scope
Clinical forms and targeted data capture
Customization Options
Dynamic electronic data capture tailored to study-specific forms and workflows.
Regulatory Integrity & Human Oversight
Technological flexibility must preserve data integrity and appropriate regulatory controls. CISYS develops, documents, and manages custom configurations, integrations, and deployments within its quality management processes.
Human Review of Automated Outputs
Workflows may use optical character recognition (OCR) and automated redaction of protected health information (PHI). Review and approval steps should be defined in study procedures, based on intended use and risk. Machine-assisted outputs are subject to appropriate human review before approval or finalization.
Validation, Privacy & Security
Validation is informed by GAMP 5 guidance, including Category 4 and 5 software as applicable. Controls support applicable 21 CFR Part 11, HIPAA, and GDPR requirements, with information security practices informed by ISO/IEC 27001. Audit trails support traceability of record changes and relevant administrative actions.
Collaborative Delivery Lifecycle
Our partnership model supports coordination from initial protocol review through final database lock, with clear responsibilities and documented handoffs.
01
Clinical Discovery
Protocol and charter review, data intake analysis, and site workload assessment with technical architects.
02
Targeted Build
Configuration of Sequence modules, API integrations, and study-specific decision logic.
03
Risk-Based Validation
Risk-based testing, IQ/OQ/PQ where applicable, user acceptance testing (UAT), and validation records.
04
Lifecycle Support
Impact assessment and controlled updates for protocol amendments, added sites, and evolving requirements.
Why Clinical Leaders Partner with CISYS
Direct Technical Collaboration
Work directly with clinical systems architects experienced in software engineering and regulated clinical operations.
Ecosystem Interoperability
Connect with electronic data capture (EDC) systems, imaging repositories, and central laboratories through APIs, based on study requirements and available interfaces.
Continuous Adaptability
In-house engineers evaluate emerging challenges and develop targeted solutions throughout the trial lifecycle.
Discuss Your Study
Share your protocol or adjudication charter for a technical review. Meet with CISYS solution architects to map custom workflows and integrations, then receive a functional specification, validation timeline, and implementation plan.
