Frequently Asked Questions

Clinplex covers five regulatory domains across the full drug lifecycle: (1) Discovery & Preclinical — GLP compliance under 21 CFR Part 58, data integrity under Part 11, IND-enabling study readiness; (2) Clinical Trials — GCP compliance under ICH E6(R2), IND/CTA submissions under 21 CFR 312; (3) Manufacturing & Quality — GMP compliance under 21 CFR 210/211/820, ICH Q7–Q12; (4) Regulatory Submissions — eCTD Module 1–5 completeness, NDA/BLA readiness under ICH M4; (5) Post-Market & Pharmacovigilance — PSUR/PBRER compliance under ICH E2C(R2), adverse event investigation, EU GVP modules. Plus cross-domain pattern detection that connects signals across all five domains.

No. Clinplex AI is not a Quality Management System, Clinical Trial Management System, Regulatory Information Management system, or safety database. It is the regulatory intelligence layer that works alongside your existing platforms via API integration. Your QMS manages document workflows. Your CTMS manages trial operations. Your RIM system manages submissions. Clinplex adds the regulatory content analysis, compliance gap detection, and cross-domain intelligence these systems were never built to provide.

Cross-domain pattern detection is Clinplex's core differentiator. It identifies regulatory signals that span multiple lifecycle domains — connections that siloed tools cannot see. A manufacturing deviation pattern that impacts NDA submission timelines. A PV safety signal that requires labeling updates and clinical protocol amendments simultaneously. A GLP data integrity finding that invalidates the safety basis of an IND application. These cross-domain patterns are where the highest-consequence regulatory risks live — and Clinplex is the only platform that spans all five domains to detect them.

Pharmaceutical RegTech refers to technology solutions that automate regulatory compliance processes across the drug lifecycle — AI-powered gap analysis, regulatory change management, submission readiness tools, and compliance monitoring. Clinplex AI represents the newest RegTech category: a platform that uses artificial intelligence to provide continuous regulatory intelligence across GLP, GCP, GMP, submissions, and pharmacovigilance with capabilities traditional domain-specific tools and manual audits cannot match.

No. Clinplex works two ways. Path A (Standalone): Upload any regulatory document — GLP protocols, clinical study reports, SOPs, batch records, eCTD modules, PV reports — directly for immediate analysis. No QMS, CTMS, or RIM system required. Path B (Integrated): Connect Clinplex to your existing systems for continuous monitoring across every domain. Pre-IND biotechs managing documents in file folders get the same depth of intelligence as enterprise pharma running Veeva across 50 sites.

Clinplex integrates with enterprise platforms across the lifecycle via API connections: QMS platforms (Veeva Vault via REST API, MasterControl via RESTful API, TrackWise, SAP QM), clinical trial management systems (CTMS), regulatory information management systems (RIM), and safety databases for pharmacovigilance. The integration is non-disruptive — no workflow changes, no user retraining, no data migration. Both upload and integrated paths can be used simultaneously.

Any regulatory document from any lifecycle stage: GLP study protocols and reports, clinical protocols, informed consent forms, investigator brochures, clinical study reports, SOPs, batch records, deviation reports, CAPA records, process validation documents, eCTD modules (1–5), CMC documentation, PSURs/PBRERs, risk management plans, adverse event investigation reports, and regulatory correspondence. Supported formats: PDF, Word (.docx), Excel (.xlsx).

Approximately 2.4 seconds per document. Upload a GLP study report, clinical protocol, manufacturing SOP, eCTD module, or PSUR and receive a complete severity-scored gap report with exact regulatory citations in seconds.

Every gap report provides: identified compliance gaps mapped to specific regulatory requirements with exact citations (CFR section, ICH guideline paragraph, EU GMP annex reference), severity classification (Critical, Major, Minor), remediation guidance with prioritized action items, investigation adequacy scoring for deviations and CAPAs, cross-domain impact assessment for integrated customers, and an overall compliance score.

For document upload (standalone mode), there is no implementation — upload a document and receive a gap report in seconds. For system integration with Veeva Vault, MasterControl, TrackWise, SAP QM, or other platforms, implementation typically takes weeks rather than the 12–18 months required for QMS deployments. No data migration, workflow changes, or user retraining is required.

150+ regulatory frameworks including: FDA 21 CFR Parts 11, 50, 56, 58, 210, 211, 212, 312, 314, 600, 601, 610, 820; ICH guidelines E2A–E2F (safety), E3 (clinical study reports), E6(R2) (GCP), M3(R2) (nonclinical studies), M4 (CTD/eCTD), Q1–Q14 (quality), S guidelines (safety); EU GMP Annexes 1, 11, 15; EU GVP Modules; EMA submission requirements; eCTD v4.0 specifications; ISO 13485 and ISO 14971; FDA guidance documents; and enforcement data from actual FDA 483 observations and warning letters.

The most frequently cited include: failure to thoroughly investigate discrepancies (21 CFR 211.192 — the number one citation for over a decade), failure to establish and follow written procedures (21 CFR 211.100), laboratory control deficiencies including inadequate OOS investigations (21 CFR 211.160), equipment cleaning and maintenance gaps (21 CFR 211.67), and data integrity failures (21 CFR Part 11). AI compliance platforms analyze quality records against these high-frequency patterns to prevent findings before inspectors identify them.

Yes. Clinplex analyzes quality records against regulatory frameworks specific to biologics, including 21 CFR Parts 600–680, FDA guidance on cell and gene therapy manufacturing, ICH Q5 series for biotechnological products, and EU GMP Annex 1 for sterile manufacturing. This includes evaluation of aseptic processing documentation, environmental monitoring programs, cell bank characterization, viral clearance validation, and the unique quality considerations for living cell therapies.

Clinplex evaluates preclinical documentation against 21 CFR Part 58 GLP requirements, ICH M3(R2) nonclinical study requirements, and 21 CFR Part 11 data integrity standards. This includes GLP study protocol documentation, raw data integrity controls, QA statement completeness, final study report adequacy, and IND-enabling study readiness. Cross-domain intelligence identifies where preclinical documentation gaps create downstream problems in IND applications and clinical programs.

Clinplex evaluates clinical trial documentation against ICH E6(R2) GCP requirements, 21 CFR Part 312 IND regulations, 21 CFR Part 50 informed consent requirements, and FDA clinical trial guidance. This includes clinical protocol gap analysis, informed consent document adequacy, investigator brochure completeness, clinical study report structure against ICH E3, and IND submission readiness scoring. Cross-domain intelligence connects clinical findings to manufacturing, submission, and pharmacovigilance implications.

Clinplex evaluates eCTD modules against ICH M4 content requirements and FDA/EMA-specific guidance. The AI checks whether each Module section satisfies its specific regulatory requirements, verifies cross-module consistency (e.g., Module 2.5 Clinical Overview references matching Module 5 study reports), and provides a quantified submission readiness score. This identifies documentation deficiencies that would trigger Complete Response Letters — before the submission is filed.

Clinplex evaluates PV documentation against the full regulatory framework — ICH E2A through E2F, 21 CFR 314.80/314.98, EU GVP Modules, and REMS guidance. Capabilities include PSUR/PBRER content adequacy scoring against ICH E2C(R2), risk management plan evaluation against EU GVP Module V, adverse event narrative quality assessment, signal-to-action mapping across regulatory domains, and CIOMS reporting completeness. Cross-domain intelligence connects PV signals to their downstream impact on labeling, clinical protocols, and manufacturing risk assessments.

Clinplex provides predictive inspection risk assessment based on actual FDA enforcement data — 483 observations, warning letter patterns, and Complete Response Letter trends. The platform maps compliance gaps to the six FDA inspection systems, identifies which gaps align with current enforcement priorities, and provides continuous readiness monitoring. Organizations using AI compliance intelligence typically detect gaps 87% faster than manual review processes.

Clinplex performs cross-record pattern detection by analyzing quality events across all connected sites and systems simultaneously — correlating deviations across production lines, identifying recurring root cause categories across facilities, detecting CAPA ineffectiveness patterns that span sites, and surfacing emerging risk trends invisible from any single site's data. Three seemingly unrelated deviations at two sites may share a common contributing factor — AI surfaces this connection automatically.

Pre-clinical & emerging biotech — building regulatory infrastructure, preparing IND-enabling documentation. Clinical-stage companies — managing GCP compliance, IND/CTA submissions, clinical documentation. Mid-size pharma & CDMOs — GMP manufacturing compliance, cross-site monitoring, continuous quality intelligence. Commercial pharmaceutical companies — full lifecycle management across manufacturing, submissions, and PV. Regulatory affairs teams — submission readiness, eCTD analysis, regulatory change tracking. Pharmacovigilance teams — PSUR/PBRER compliance, signal detection, risk management.

AI has eliminated the traditional barrier. Growth-stage biotech companies can start by uploading individual documents for immediate gap analysis — GLP protocols, clinical study reports, SOPs — without deploying enterprise systems or engaging $500K consulting firms. The analysis provides the same regulatory depth (FDA CFRs, ICH guidelines, exact citations) that large pharma receives, at a fraction of the cost. As the company grows, the platform scales from upload to direct system integration.

Clinplex protects regulatory data with the same rigor 21 CFR Part 11 demands — encryption at rest and in transit, audit trail integrity, role-based access controls, and data sovereignty controls. Your regulatory and compliance data is competitive advantage and is treated accordingly.

Contact us for pricing at clinplex.com/contact. We offer a free single document analysis — from any lifecycle stage — so you can evaluate the platform on your own documentation before committing.

Two options: (1) Upload a document for free analysis — any regulatory document from any lifecycle stage (GLP protocol, clinical study report, SOP, eCTD module, PV report). Get a severity-scored gap report in seconds. No commitment required. (2) Schedule a demo — see the full platform including cross-domain intelligence, continuous monitoring, and integration capabilities. Visit clinplex.com/contact.