IT Services for Clinical Trials
Validated, compliant IT infrastructure for pharmaceutical companies, CROs, and research institutions managing clinical trial data under FDA 21 CFR Part 11 and ICH-GCP requirements.
Two Pillars of Clinical Trial IT
Validated infrastructure that satisfies FDA, ICH-GCP, and HIPAA requirements simultaneously.
Data Integrity and Validation
- 21 CFR Part 11 compliant audit trails, access controls, and electronic signatures
- ALCOA+ data integrity framework across all clinical systems
- Computer system validation (IQ/OQ/PQ) aligned with GAMP 5
- Documented change control to maintain validated state
Secure Infrastructure
- HIPAA-compliant ePHI encryption at rest (AES-256) and in transit (TLS 1.2+)
- Multi-site VPN architectures connecting sponsors, CROs, and investigator sites
- Disaster recovery with regulatory retention requirements (15+ years)
- Layered cybersecurity defenses for high-value research data
Clinical Trial IT Services
Every technology layer research organizations depend on, with regulatory compliance built in.
EDC System Deployment
Infrastructure for Medidata Rave, Oracle Clinical, Veeva Vault, OpenClinica, and REDCap -- from server provisioning to production support.
Clinical Data Management
Server, storage, and network infrastructure powering your CDMS with capacity planning, database tuning, and high-availability clustering.
21 CFR Part 11 Systems
Tamper-evident audit trails, role-based access, electronic signature mechanisms, and security procedures that satisfy every Part 11 requirement.
HIPAA-Compliant Data Transfer
Encrypted storage and SFTP-based data exchange between sponsors, sites, and labs with documented retention and BAA management. See our HIPAA compliance services.
Multi-Site Trial Networks
Site-to-site VPN, QoS prioritization for clinical data, redundant connections, and centralized monitoring across all trial locations.
Disaster Recovery
Automated backups with offsite replication, documented RTO/RPO, regular DR testing, and failover infrastructure. See our backup services.
Our Implementation Process
Regulatory requirements assessment and gap analysis
Infrastructure design and validation planning
System deployment with IQ/OQ/PQ qualification
Staff training and SOP development
Ongoing monitoring and compliance auditing
Quarterly compliance reports and inspection readiness
Built For Clinical Research
Clinical Trial IT Questions
What IT infrastructure do clinical trials need?
Clinical trials require servers or cloud environments for CDMS and EDC platforms, databases configured for clinical data volumes, network infrastructure connecting all trial sites, security controls satisfying 21 CFR Part 11 and HIPAA, backup systems meeting regulatory retention requirements, and monitoring for infrastructure health and security events.
What is 21 CFR Part 11 compliance?
FDA 21 CFR Part 11 governs electronic records and electronic signatures used in FDA-regulated activities. Every system creating or transmitting trial data must meet requirements for audit trails, access controls, electronic signatures, system validation, and data integrity. Non-compliance can result in Warning Letters, data rejection, and approval delays.
How do you handle HIPAA in clinical trial environments?
We implement AES-256 encryption at rest, TLS 1.2+ in transit, role-based access controls, comprehensive audit logging, secure disposal procedures, and workforce training. We execute BAAs with all healthcare clients. Learn more on our HIPAA compliance page.
What EDC systems do you support?
We support Medidata Rave, Oracle Clinical, Veeva Vault CDMS, OpenClinica, and REDCap. For cloud platforms, we manage network connectivity, SSO, and API configuration. For on-premises platforms, we handle full server deployment, database management, and application configuration.
Can you help with computer system validation?
Yes. We provide infrastructure documentation, configuration evidence, IQ/OQ/PQ test protocols and results, and ongoing change control documentation aligned with GAMP 5 guidelines that satisfies FDA inspectors and sponsor auditors.
Do you support decentralized clinical trials?
Yes. We support mobile device management for trial-provisioned devices, secure connectivity for patient-owned devices, offline data synchronization, telemedicine platforms, remote patient monitoring integration, and wearable data aggregation -- all with the same regulatory compliance controls as traditional site-based infrastructure.
Explore More
Healthcare IT Services
HIPAA-compliant managed IT for hospitals, clinics, and medical practices.
Managed IT Services
24/7 monitoring, help desk, and infrastructure management for regulated industries.
Cloud Services
Scalable computing resources for analytics workloads and clinical data platforms.
HIPAA Security Guide
Detailed implementation guidance for HIPAA technical safeguards.
Ready to Build Compliant Clinical Trial Infrastructure?
Our team will assess your regulatory requirements and design validated infrastructure that keeps your trial on track.