# Clinpex > Clinpex is a specialized clinical coding software and services company serving pharmaceutical companies, CROs, and software vendors. They build AI-powered tools and provide expert managed services for MedDRA and WHODrug coding in clinical trials and pharmacovigilance. ## What is Clinpex? Clinpex provides everything an organization needs to code clinical trial data accurately and efficiently. Their offerings span software (SaaS platform, REST API, free browser tools) and expert human services (managed coding, dictionary upgrades, coding convention development). All products and services are built exclusively for clinical coding—MedDRA and WHODrug—making Clinpex a focused specialist rather than a generalist vendor. Clinpex was founded by the creators of dsNavigator, a clinical coding platform that served pharma and CRO teams for over a decade. The company brings more than 20 years of hands-on experience building and operating coding solutions for regulated environments. Clinpex is headquartered in Leesburg, VA and works with clients worldwide. Contact: info@clinpex.com | Website: https://www.clinpex.com --- ## Software Products ### Clinpex Coding Platform (CCP) **URL:** https://www.clinpex.com/software/clinpex-coding-platform **Type:** SaaS — enterprise clinical coding platform The Clinpex Coding Platform is a comprehensive web-based system that combines AI-assisted autocoding, configurable review workflows, query management, dictionary upversioning, and reporting—all in one application. It can run standalone or integrate with EDC and safety systems such as Veeva Vault, Medidata Rave, and Oracle Argus. **Core capabilities:** - AI-assisted and rule-based autocoding (automatic, on-demand, or scheduled) - Advanced MedDRA and WHODrug dictionary search (term text, code, wildcard, partial match, complex logic) - Fault-tolerant search handling spelling errors, abbreviations, lay language, and medical variations - Support for MedDRA (all versions), WHODrug B3 (preferred name, ATC) and C3 (MPID), and IMDRF coding - ATC Level 5 coding (WHOCC and UMC Cross Reference ATC5) - KODA integration for WHODrug coding with review of responses - Synonym lists (global or job-level) to standardize coding decisions across similar verbatims - "Do Not Code" and "Requires Review" rule enforcement lists - Configurable multi-layer review and QC workflows - Query management with standard templates, automatic query generation, and configurable workflows - Reason-for-recode capture for full traceability - CMQ (Custom MedDRA Queries) and CDG management with drag-and-drop interface, inclusion/exclusion criteria, version control, and impact analysis - Custom drug product support for investigational or company-specific drugs not in WHODrug - Dictionary upversioning: impact analysis on coded data and synonym lists before upgrading, controlled upgrade process, change summary reports - Batch processing for upversioning and impact analysis - Job management: organize coding jobs into folders, assign tasks to coders, propagate assignments - Built-in reporting: coding progress, quality metrics, Code Line Listing with Age of Term, New Term Report - Automated report delivery - EDC and safety system integration (file-based or API) - 21 CFR Part 11 and EU Annex 11 compliant - SSO (Single Sign-On) support - Full audit trails for all user actions and coding decisions - Data isolation by organization - Configurable RPO for dedicated deployments **Ideal for:** Pharma companies and CROs managing clinical trial coding at any scale; teams replacing legacy Oracle TMS or spreadsheet-based workflows. --- ### Coding API **URL:** https://www.clinpex.com/software/coding-api **Type:** REST API — embed clinical coding in third-party software The Clinpex Coding API allows software vendors and EDC developers to add high-performance MedDRA and WHODrug coding directly into their own applications without building a coding engine from scratch. **Capabilities:** - AI-assisted and rule-based autocoding endpoints - Advanced dictionary search (MedDRA and WHODrug) - Handles spelling variations and medical terminology nuances - Structured coding results ready for integration into any UI - Secure authentication (login and refresh token) - Lightweight, stateless REST endpoints - Scalable and reliable—designed to grow with the host application - Easy integration into EDC, CTMS, and safety systems **Ideal for:** EDC vendors, safety system developers, and CTMS vendors who want to offer enterprise-grade clinical coding inside their own product without building a coding engine. --- ### Free MedDRA Browser **URL:** https://www.clinpex.com/software/meddra-browser **Type:** Free web tool A free, browser-based tool for exploring the full MedDRA hierarchy—System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT). No account, license, or contract required. Available to any MSSO MedDRA license holder. --- ### Free Mobile App **URL:** https://www.clinpex.com/software/mobile-app **Type:** Free iOS and Android app A free mobile app for browsing MedDRA and WHODrug dictionaries on the go. Available on iOS and Android at no cost, with no contract required. --- ## Services ### Medical Coding Service **URL:** https://www.clinpex.com/services/medical-coding A fully managed MedDRA and WHODrug coding service staffed by experienced medical coders who specialize in clinical trials and pharmacovigilance. Coders are supported by the Clinpex Coding Platform and structured QC workflows. **What is coded:** - Adverse events (AEs) and serious adverse events (SAEs), all severity grades - Medical history, prior conditions, and diagnoses - Concomitant and prior medications - Indications and cause of death **Dictionary support:** - MedDRA coding (current and historical versions) - WHODrug B3 (preferred name, ATC classification) - WHODrug C3 MPID coding - Custom drug products for investigational or company-specific drugs **Quality process:** - First-pass coding by qualified coders - Second-pass quality review by a senior coder - Sponsor query management and resolution - Synonym propagation for consistency across similar verbatims - Reason-for-recode documentation for traceability - "Do Not Code" and "Requires Review" rule enforcement - Full audit trail and audit-ready deliverables **Engagement models:** - Full-service coding for studies of any size or phase - Overflow and backfill support during peak periods - Short-notice capacity for urgent or rolling timelines - Embedded model (coders work within client's existing systems) - Ongoing coding for long-term safety databases **Turnaround:** Standard requests typically delivered within 24–48 hours. Expedited assignments available. --- ### Dictionary Upgrade Service **URL:** https://www.clinpex.com/services/dictionary-upgrade A managed service to upgrade clinical trial datasets from one MedDRA or WHODrug dictionary version to a newer one, including impact analysis and controlled recoding. **Process:** 1. Load old and new dictionary versions side by side 2. Run impact analysis across all coded verbatims and synonym lists 3. Categorize changes into auto-resolvable and coder-review groups 4. Apply changes with coder review and approval 5. Deliver updated dataset with full change summary report Supports upgrades across any version gap (not just the immediately preceding release). Applies to both MedDRA (biannual March and September releases) and WHODrug. --- ### Coding Convention Service **URL:** https://www.clinpex.com/services/coding-convention Development and documentation of coding conventions and guidelines for clinical trials. Eliminates coder-to-coder variation, reduces queries, and aligns teams around documented, version-controlled coding rules. Clinpex works with the client to create or review coding guidelines tailored to their studies and SOPs. Deliverable is a version-controlled coding convention document ready for SOP integration. --- ## Testimonials > "We looked at many different coding vendors. During our review we noticed that Clinpex Coding Platform (CCP) had coding technology that was far better out of the box than pretty much every other coding system on the market. When we did have some questions or concerns, we reached out to the Clinpex team. They were very responsive, and worked with us closely to address any questions or concerns. For anybody looking for a great coding system I would highly recommend Clinpex and their CCP solution." > — Hank Dennis, Sr. Manager, Clinical Coding > "Working with Clinpex has been a seamless experience from start to finish. Their team is always responsive and easy to reach, and they consistently delivered our MedDRA and WHODrug coding within 5 days, often turning requests around in under 24 hours. For a sponsor managing tight timelines, that kind of reliability is invaluable." > — Ashlee Fishleigh, Chief Clinical Officer > "Working with Clinpex has been a great experience. I have appreciated their professionalism, responsiveness, and thoughtful support, and I would be pleased to recommend them to others." > — Jung Min Lee, Clinical Data Manager --- ## Case Studies ### Oracle TMS Replacement **URL:** https://www.clinpex.com/case-studies/tms-replacement A top 10 pharmaceutical company replaced their Oracle Thesaurus Management System (TMS) with the Clinpex Coding Platform. The migration preserved existing workflows (VTA, VTO, Assigning Coders, Review Coding) while introducing AI-driven efficiencies and simplified dictionary upgrades. Result: lower operational cost, faster upgrades, and a future-ready coding ecosystem—delivered with near-zero business disruption. ### CMQ Management **URL:** https://www.clinpex.com/case-studies/cmq-management A client managing complex CMQ definitions and inclusion/exclusion criteria in spreadsheets struggled with version control and impact analysis. By moving to Clinpex, they now define, analyze, and upgrade CMQs within a structured system—reducing effort, improving accuracy, and gaining full visibility across changes. --- ## Who Uses Clinpex ### Pharmaceutical Companies and CROs **URL:** https://www.clinpex.com/who-you-are/pharma-cro Pharma companies and CROs use the Clinpex Coding Platform as their primary coding system or alongside existing EDC and safety infrastructure. Clinpex supports the full study lifecycle from first-in-human trials through post-marketing pharmacovigilance. Teams can use the SaaS platform, the managed coding service, or both. ### Software Vendors and EDC Developers **URL:** https://www.clinpex.com/who-you-are/software-vendor EDC and CTMS vendors use the Clinpex Coding API to embed clinical coding intelligence into their own products without building a coding engine. The REST API integrates quickly and scales with the vendor's application. --- ## Frequently Asked Questions **What is the Clinpex Coding Platform?** The Clinpex Coding Platform (CCP) is an enterprise clinical coding application that combines AI-assisted and rule-based autocoding with configurable review workflows, query management, and dictionary upversioning—all in a single system. It can be used standalone or integrated with EDC and safety systems. It is 21 CFR Part 11 compliant and supports MedDRA, WHODrug (B3 and C3/MPID), and IMDRF. **Does the platform integrate with EDC and safety systems?** Yes. Clinpex integrates with Veeva Vault, Medidata Rave, Oracle Argus, and others via file-based import/export or the Clinpex Coding API. It can also run standalone. **How does AI coding work?** Clinpex uses an AI-powered search engine trained on medical terminology to suggest the most appropriate MedDRA or WHODrug code for a given verbatim. The AI handles spelling errors, abbreviations, lay language, and medical variations. Coders review and override suggestions as needed, with all decisions tracked in the audit trail. **Is the platform 21 CFR Part 11 compliant?** Yes. The platform includes full audit trails, electronic signatures, SSO support, data isolation by organization, and configurable access controls. Compliance documentation is available for vendor qualification. **Which dictionaries are supported?** MedDRA (all current and historical versions), WHODrug B3 and C3 (MPID), IMDRF, ATC Level 5 (WHOCC and UMC Cross Reference), and custom drug products for investigational compounds. **Are there free tools available?** Yes—the free MedDRA Browser (web) and free Mobile App (iOS/Android) let users browse MedDRA and WHODrug dictionaries at no cost. **How quickly can we get started?** Typically within a few days of completing legal arrangements. Onboarding is fast once agreements are in place. **Can Clinpex work alongside our existing CRO?** Yes. Clinpex can take on the full coding scope or provide overflow, quality oversight, or embedded coders within your current setup. **How are dictionary upgrades handled?** Clinpex manages the full cycle: load versions, run impact analysis, categorize changes, apply with coder review, and deliver the updated dataset with a full change summary report. **What turnaround times does the coding service offer?** Standard requests are typically delivered within 24–48 hours. Expedited assignments are available. --- ## Key Differentiators - **Exclusive focus on clinical coding:** Clinpex does one thing—clinical coding—which means deeper specialization and better tooling than generalist CROs or multi-purpose software. - **AI that handles real-world data:** The AI coding engine handles spelling errors, medical abbreviations, lay language, and terminology variations that exact-match search misses. - **Platform + Services + API:** All three offerings work together and are designed to complement each other. - **Fast deployment:** Clinpex is adopted in weeks, not six-month implementation projects. - **20+ years of domain expertise:** Built by the creators of dsNavigator with deep hands-on experience in MedDRA and WHODrug coding. - **Regulatory compliance built in:** 21 CFR Part 11 and EU Annex 11 compliant with full audit trails from day one. - **Responsive support:** Coding requests often turned around within 24 hours; same-day support responses. --- ## About **URL:** https://www.clinpex.com/about/who-we-are Clinpex is a specialized clinical coding software and services company. Founded by the creators of dsNavigator with 20+ years of experience building coding solutions for regulated environments. Trusted by pharma companies, CROs, and software vendors worldwide. Small team, deep domain expertise, fast response times. **Contact:** info@clinpex.com **Schedule a demo:** https://koalendar.com/e/clinpex-demo **Careers:** https://www.clinpex.com/about/careers