

Full cycle product for R&D teams in Pharmaceutical Industry. The product includes Electronic Trial Master File, Trial Management, Electronic Document Management with eSignature support. That is suitable for regulated areas as it is fully compliant with 21CFR Part 11 requirements.

Chronicles eCRF is a configurable SaaS solution which may be set up by clients in strict compliance with the protocol in both interventional (Phase I-IV and BE/BA) studies and non-interventional programs. • Integrated randomization, stratification and blinding. • Built-in trial supply management tools. • Study-specific form builder with edit checks, lab ranges, and multi-language support. • MedDRA and ATC coding, CDISC/CDASH-ready datasets. • Compatibility with modern statistical software such as SAS, R, SPSS, Excel, etc.

Electronic Trial Master File for compliant document storage, workflows, and inspection readiness. • Templates, versioning, electronic signatures, and role-based access. • QC workflows and audit trails aligned with GxP and 21 CFR Part 11 requirements.

Secure portal for central readers, KOLs, and investigators to review and share data and documents. • Built-in DICOM anonymization, centralized imaging assessment (MRI/CT), and remote monitoring. • Controlled reviewer access. • eCRF-like report forms. • Collaboration tools to support central review processes.
Chronicles Research is an eClinical SaaS provider helping CROs and pharmaceutical companies run clinical trials faster and more cost-effectively with a validated, GxP-compliant platform. It was founded by clinical research and software experts in 2021. The systems are easy to deploy in any region and may be configured by clients themselves. Products: eCRF with integrated RTSM, CTMS, eTMF, Central Review Share. Compliance: FDA 21 CFR Part 11, EU CTR, MDR, ICH GCP, ISO 14155. For whom: CROs, emerging pharma/biotech, medical universities and research centers. Key advantages: Fast setup, integrated vocabularies, reduced total cost vs. enterprise vendors, multi-language UI, customer-focused support.