The Statandocs software ecosystem

Proprietary products for regulatory, scientific and research workflows. SaaS is the main delivery model. We implement and support our solutions.

PharmaDocker

Available product

A regulatory services ecosystem: variation assistance, applicant portal and registry workflows, and regulatory and literature monitoring.

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PharmaReview

Available product

Systematic reviews and meta-analyses: literature workflows, screening, extraction, study appraisal and preparation of results.

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PharmaQMS

Available product

An electronic quality management system for documents, training, deviations, CAPA, change control, audits and other quality processes.

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OmniEDC

Available product

Electronic data capture and management for clinical studies, as a standalone product in the Statandocs ecosystem.

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Specialised systems

Statandocs Chronicle

Dossier assembly and eCTD XML for the EAEU, with a separate WHO module. Individual submission sequence assembly is available as a service.

Study systems and 1C

Statandocs operates its own extensive OpenClinica fork with IWRS/IRT for randomisation, allocation and investigational product tracking. This system and Chronicle are integrated with proprietary 1C configurations.

The ecosystem in development

ModuleTwo — a system being developed to assemble complete regulatory dossiers using AI agents.

Staccato — pharmaceutical translation with source traceability and human review.

These products are at different stages of internal use and testing.

Implementation and support

We agree the use case, implement the product and provide support. On-premise versions are being prepared for a number of solutions; availability is discussed for the specific product.

The company develops proprietary products and does not offer custom software development.

Where do we start?

Tell us about your product and objective. We will assess the available information, identify what is needed and agree the right scope of work.

Discuss your project