Chronicles Research Team
- Perfis 4
- Categorias 2
Todos os Produtos e Serviços
Produto de ciclo completo para equipes de P&D na Indústria Farmacêutica. O produto inclui Arquivo Mestre de Ensaios Eletrônicos, Gestão de Ensaios, Gestão Eletrônica de Documentos com suporte a Assinatura Eletrônica. Isso é adequado para áreas regulamentadas, pois está totalmente em conformidade com os requisitos da 21CFR Parte 11.
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 Team Avaliações
Sobre
O que é Chronicles Research Team?
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.
Detalhes
