Get to know us

Based in North Carolina, we provide specialized Pharmacovigilance (PV) IT support tailored specifically to the unique needs and resource constraints of Non-Profit Academic Clinical Research Institutes (ACRIs). Our focus is on ensuring your clinical trial safety database operations are compliant, efficient, and cost-effective.

Key Services for Academic Institutions

Academic research faces distinct PV challenges, including limited dedicated IT staff, diverse trial portfolios, and the critical need for regulatory compliance (FDA, ICH-GCP) without a large commercial budget. Our support model addresses these needs directly.

1. ⚙️ Safety Database Administration & Maintenance

We act as your dedicated expert PV IT team, managing the day-to-day operations of your safety system (e.g., Oracle Argus Safety, ARISg, etc.).

System Health Checks: Routine monitoring and optimization of the database and server environment to ensure peak performance and minimal downtime.
User Management: Creation, modification, and termination of user accounts, role-based security configuration, and periodic access reviews to maintain 21 CFR Part 11 compliance.
Routine Maintenance: Application of vendor patches and updates (e.g., MedDRA/WHO Drug Dictionary updates), and coordination of system backups and disaster recovery testing.
Regulatory Compliance Support: Configuration of local and international reporting rules (e.g., electronic submission gateways for FDA and EMA) to ensure timely and accurate reporting of Serious Adverse Events (SAEs).

2. 📝 Validation & Documentation

For non-profit ACRIs, demonstrating GxP compliance through robust documentation is crucial for audit readiness. We streamline this complex process.

Computer System Validation (CSV): Development and execution of required validation documents, including:
- Validation Plan (VP)
- User Requirements Specification (URS)
- Functional Specification (FS)
- Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Traceability Matrix
Standard Operating Procedures (SOPs): Creation or update of PV IT SOPs governing database usage, security, change control, and system administration, tailored to your ACRI's processes.

3. 📊 Custom Reporting & Data Access

We enable your safety and biostatistics teams to extract the critical safety insights needed for clinical reviews, DSURs (Development Safety Update Reports), and regulatory submissions.

Custom Report Generation: Developing validated, institution-specific reports and outputs from the safety database to support Safety Review Committee (SRC) meetings and study monitoring.
Data Export Expertise: Facilitating secure and compliant data exports to support Statistical Analysis Plans (SAP) and integration with other clinical data systems (e.g., EDC).
Query Optimization: Tuning database queries to improve the speed of data retrieval and report generation.

Why Partner with a North Carolina PV IT Expert?

Cost-Effectiveness: Access high-level, specialized PV expertise on a flexible, fractional basis, avoiding the overhead of a full-time, dedicated PV IT staff.
Focus on Research: Our support allows your core clinical research personnel to focus on scientific outcomes and patient care, not complex IT maintenance.
Regional Alignment: Operating out of North Carolina ensures we are accessible and aligned with the operational needs and time zones of research institutions within the major regional biotech and academic hubs (e.g., Research Triangle Park).

Specific Challenges We Address for ACRIs

ACRI ChallengeOur Expert Support SolutionLimited IT BudgetFlexible, tiered support contracts for predictable, lower costs.Diverse Protocol NeedsConfiguration of the database for multiple, disparate clinical trial protocols and varying safety reporting requirements.In-House Audit RiskProviding complete, up-to-date validation documentation and audit-trail review/management.Staff Turnover/TrainingConsistent, high-quality knowledge retention and 24/7 coverage, independent of your internal staffing change.

Gopal

Founder/President

People and culture

Our people are what make us unique. Rather than outsourcing our construction engineers from questionable outsourcing establishments, we provide them with an environment that supports professional growth.

We are strong believers in giving our employees a voice. Our teams are put together with the help of our Practice Manager to ensure maximum productivity and engagement.