Frequently Asked Questions

Our office is in Leesburg, VA, but we work with clients worldwide. We are experienced at collaborating remotely across time zones and have an established process for communication, file exchange, and project management that keeps things running smoothly regardless of geography.

Typically within a few days of completing legal arrangements. The contracting process is usually the main variable—once agreements are in place, onboarding is fast. We are set up to start immediately once the paperwork is done, and we can work in parallel on project scoping while contracts are being finalized.

Send an email to info@clinpex.com and someone from our team will get back to you promptly. You can also schedule a call directly through the contact options on any page of our site.

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, safety, and data management systems. It is 21 CFR Part 11 compliant and supports MedDRA, WHODrug (B3 and C3/MPID), and IMDRF coding.

Yes. Clinpex integrates with major EDC and safety systems including Veeva Vault, Medidata Rave, Oracle Argus, and others. Data can be exchanged via file-based import/export or through the Clinpex Coding API. The platform can also run as a standalone system with manual data import and export if no direct integration is needed.

The Clinpex Coding API is a set of REST endpoints that allow software vendors and EDC developers to embed high-performance MedDRA and WHODrug coding directly into their own applications—without building a coding engine themselves. The API supports AI-assisted and rule-based autocoding, advanced dictionary search, and handles spelling variations and medical terminology. It is designed to be lightweight, secure, and easy to integrate.

Yes—two. The free Clinpex MedDRA Browser lets you explore the full MedDRA hierarchy (SOC, HLGT, HLT, PT, LLT) in a web browser without any account or license. The free Clinpex Mobile App (iOS and Android) lets you browse MedDRA and WHODrug dictionaries on the go. Both are available at no cost and require no contract.

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 that exact-match search would miss. You can run AI coding automatically in batch mode, on a schedule, or on-demand. Human coders review and override suggestions as needed, with all decisions tracked in the audit trail.

Clinpex focuses exclusively on clinical coding, which means deeper specialization, better tooling, and a more favorable cost-to-quality ratio than most CROs can offer as one part of a broader service portfolio. Our coders work within your existing CRO setup if needed—we can take on the full coding scope or provide overflow and quality oversight. Either way, you get a dedicated coding partner rather than a generalist team.

We offer MedDRA and WHODrug medical coding (adverse events, medical history, concomitant medications, indications, and more), dictionary upgrade services (impact analysis and controlled upversioning across MedDRA and WHODrug releases), and coding convention development (creating or reviewing the coding guidelines your team codes to). We also provide synonym list management and can support CMQ/CDG definition and upversioning.

Quality is built into every step. We use a structured workflow: first-pass coding, second-pass QC by a senior coder, and sponsor query management. All coders follow client-specific coding conventions, and synonym lists are maintained to propagate consistent decisions across similar verbatims. Every coding decision is logged in a full audit trail, and reasons for recoding are captured for traceability. The Clinpex Coding Platform's "Do Not Code" and "Requires Review" rules further enforce consistency.

Not necessarily the same individual, but always the same dedicated team. Our coders collaborate closely, communicate continuously, and adhere to your project-specific coding conventions. This team-based model means continuity of quality is maintained even if individual availability changes—without you needing to manage those transitions.

Not required. If you have existing coding guidelines, we will follow them. If you do not, we apply our standard coding conventions. For organizations that want to establish or improve their guidelines, we also offer a Coding Convention development service that produces a tailored, version-controlled document ready for SOP integration.

Yes, always. We prioritize turnaround when timelines are tight. Many standard requests are delivered within 24–48 hours. Expedited work may carry a reasonable surcharge as outlined in the contract, but we will always be transparent about that upfront before proceeding.

Clinpex supports MedDRA (all current and historical versions), WHODrug B3 (preferred name, ATC classification) and C3 (MPID-based coding), and IMDRF. The platform also supports ATC Level 5 coding (WHOCC and UMC Cross Reference ATC5) and custom drug products for investigational compounds not yet available in the standard WHODrug dictionary.

It depends on how coded data flows. If Clinpex delivers coded data directly to the sponsor, the sponsor's existing license typically covers the work. If the coded data passes through your organization before reaching the sponsor, you would generally need a dictionary license for that transfer. We will help you think through the flow for your specific setup—contact us and we can walk through it with you.

Yes. The platform is built for regulated environments and is compliant with 21 CFR Part 11 and EU Annex 11. This includes full audit trails for all user actions and coding decisions, electronic signatures, SSO support, data isolation by organization, and configurable access controls. We can provide compliance documentation as part of vendor qualification activities.

We manage the full upgrade cycle: load old and new dictionary versions side by side, run an impact analysis to identify all affected coded verbatims and synonym lists, categorize changes into auto-resolvable and coder-review categories, apply changes with approval, and deliver the updated dataset with a full change summary report. This applies to both MedDRA (biannual March and September releases) and WHODrug. You can upgrade from any prior version, not just the immediately preceding one.

Yes. The platform has a custom drug product feature that lets organizations define and manage investigational or company-specific drugs that are not yet available in the standard WHODrug dictionary. These can be imported, exported, and clearly flagged in coded output so downstream systems know when a code maps to a custom entry rather than a standard WHODrug record.