CROs, biotech organisations, and research institutes need AI that understands clinical research frameworks, safety reporting obligations, and the complexity of global regulatory submissions.
Submitting the same clinical data to CDSCO, FDA, and EMA simultaneously requires navigating different formats, requirements, and timelines - a challenge that consumes months of experienced regulatory resource.
CROs managing multi-site trials depend on each site's self-reporting for status updates - creating dangerous blind spots. Protocol deviations and recruitment shortfalls are often discovered weeks after they started.
Pharmacovigilance obligations for CROs span multiple studies simultaneously. Manually reviewing adverse event data and detecting emerging signals across a large safety database requires expertise hard to scale.
System validation, process qualification, and GCP compliance documentation are still largely manual in most life sciences organisations - creating version control problems and audit exposure.
Tracking registration status across multiple health authorities - with different renewal dates, local requirements, and data formats - is a complex ongoing management challenge.
Most life sciences organisations prepare for inspections reactively - mobilising teams when an inspection is announced rather than maintaining continuous readiness.
Plans, authors, and manages regulatory submissions across multiple health authorities simultaneously - tracking status, managing response timelines, ensuring your global programme never misses a deadline.
Detects pharmacovigilance signals across your safety databases and literature using validated statistical methods - routing confirmed signals with a complete documented evidence trail.
Monitors GxP compliance across your documents, validated systems, and processes continuously - identifies gaps, tracks corrective actions, generates real-time compliance dashboards.
Tracks the registration status of your products across all health authorities - managing renewal dates, local variation requirements, and authority-specific data formats.
Gives CROs and sponsors complete real-time visibility across all trial sites - site activation, patient recruitment, protocol adherence, and any deviations automatically detected and routed.
Maintains your complete audit trail automatically across all processes, systems, and documents. When a health authority inspection is announced, your full evidence package is ready in hours.
NOVA is not a general AI told to act like a life sciences expert. It is trained on ICH E2A–E2F, MedDRA terminology, eCTD v4.0, GxP frameworks, and real clinical operations data.
Deep dive into NOVA →Semantic search across ICH guidelines, regulatory authority publications, and your study archive - understands clinical research context and regulatory terminology.
Scores clinical and regulatory decision options using life sciences logic - submission strategy, risk classification, protocol deviation severity.
Identifies pharmacovigilance signals from safety databases using validated statistical detection methods - the core engine powering SignalIQ.
Reads clinical study reports, protocol documents, site files, and validation records - extracting structured information for SubmitIQ and AuditIQ.
Compares your study protocols and SOPs against ICH, FDA, and EMA requirements - producing a detailed gap list for every document reviewed by ComplianceIQ.
Generates an immutable, time-stamped audit trail that meets ICH E6 R2 and health authority inspection requirements.
Link your CTMS, safety database, eTMF, and document management system through standard APIs. Each sponsor's data is isolated within your private environment - six architectural barriers ensure complete confidentiality.
ClinTrialOps AI tracks trial sites in real time. SignalIQ monitors your safety database for emerging signals. ComplianceIQ assesses your GxP posture. AuditIQ builds your continuous audit trail. All simultaneously from day one.
Submission documents are prepared for review, not reconstruction. Safety signals are documented and routed. Compliance gaps are identified before they become findings. Your experts focus on judgements that require genuine human expertise.