RTP biotech companies handling protected health information from clinical trials, patient registries, or collaboration with healthcare systems need IT infrastructure that meets HIPAA Technical Safeguards. We implement encryption at rest and in transit, access controls based on minimum necessary principles, audit logging for all ePHI access, and backup systems that guarantee data availability.

Our HIPAA compliance program includes risk assessments, policy development, workforce training, Business Associate Agreement management, and incident response planning. For organizations that also handle FDA-regulated data, we align HIPAA controls with 21 CFR Part 11 requirements for electronic records and electronic signatures, creating a unified compliance framework.

We support the specialized applications RTP biotech firms depend on: electronic data capture (EDC) systems like Medidata and Oracle Health Sciences, clinical trial management systems (CTMS), biobanking platforms, and research collaboration tools that require secure data sharing across multi-site studies.

Environmental testing laboratories in RTP generate data that must meet EPA quality standards for defensibility in regulatory proceedings. Data integrity controls, instrument calibration records, chain-of-custody documentation, and tamper-proof audit trails are not optional—they are requirements that determine whether your analytical results are legally admissible.

We manage LIMS (Laboratory Information Management System) infrastructure, instrument data acquisition servers, and the networks connecting analytical instruments to data repositories. Our data integrity architecture implements write-once storage for raw analytical data, version-controlled methods databases, and automated backup of instrument output files. When an EPA auditor requests a complete data package for a specific sample, your system produces it in minutes, not days.

Network design for environmental labs addresses unique requirements: isolated instrument networks that prevent cross-contamination of data, high-bandwidth connections for transferring large chromatographic data files, and redundant internet connectivity for real-time reporting to state and federal portals.

Pharmaceutical companies in RTP operate under GxP regulations that require validated computer systems for manufacturing, quality control, and regulatory submissions. Computer system validation (CSV) under GAMP 5 guidelines demands documented evidence that IT systems consistently produce results meeting predetermined specifications.

We support validation activities including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for IT infrastructure that supports GxP-regulated processes. Our change management procedures maintain validated states through infrastructure upgrades, patches, and configuration changes—documenting impact assessments, test protocols, and approval workflows that satisfy FDA inspection requirements.

For pharmaceutical manufacturers implementing AI in drug discovery or quality prediction, our team ensures AI systems meet regulatory expectations for explainability, reproducibility, and data governance. We architect ML pipelines where model training data, hyperparameters, and outputs are fully traceable—critical for AI applications that influence regulated decisions.

RTP's concentration of pharmaceutical patents, clinical trial data, trade secrets, and defense research makes it a high-value target for nation-state actors and organized cybercrime groups. A single data breach at a biotech firm can compromise years of R&D investment worth hundreds of millions of dollars. Industrial espionage targeting RTP companies has been documented by the FBI and CISA.

Our cybersecurity services for RTP include managed detection and response (MDR), penetration testing, vulnerability management, security awareness training, and incident response planning. We deploy AI-powered behavioral analytics that detect insider threats and advanced persistent threats (APTs) that conventional signature-based tools miss. Network micro-segmentation isolates research networks from corporate infrastructure, preventing a compromised email account from reaching laboratory systems.

For organizations handling CUI under CMMC, ITAR-controlled data, or export-controlled research, our compliance team implements the specific technical and administrative controls required by each framework, backed by Craig Petronella's CMMC Certified Registered Practitioner credential.

Computational biology, molecular dynamics simulations, genomic sequencing analysis, and AI-driven drug discovery all demand high-performance computing infrastructure that generic IT providers cannot architect. We design and manage HPC environments tailored to RTP research workloads: GPU clusters for deep learning, high-memory nodes for bioinformatics, parallel storage systems for large dataset processing, and job schedulers that optimize resource utilization.

Our AI infrastructure services help RTP organizations deploy machine learning platforms that maintain compliance while delivering the computational power researchers need. On-premises GPU clusters keep sensitive research data under your control, while hybrid cloud architectures burst to public cloud for non-sensitive workloads during peak demand. We support popular research frameworks including TensorFlow, PyTorch, Nextflow, Snakemake, and custom bioinformatics pipelines.

When a server failure during a multi-week experiment means starting over from scratch, standard backup strategies are not sufficient. We design disaster recovery architectures that protect irreplaceable research data with near-zero recovery point objectives: continuous data protection for active experiments, replicated databases for clinical trial systems, and immutable backups that ransomware cannot corrupt.

Business continuity planning for RTP organizations accounts for scenarios generic IT providers overlook: power failures during time-sensitive assays, network outages that interrupt instrument data acquisition, and natural disasters that threaten physical lab facilities. Our plans include automated failover for critical systems, pre-configured recovery environments, and documented procedures tested through quarterly DR drills. RTP organizations under regulatory oversight must demonstrate recovery capability to auditors—our documentation and testing satisfy these requirements.