RegDocs365. Regulated content for life science
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RegDocs365 is a compliant document management solution tailored for life science companies, enabling streamlined workflows throughout drug development stages in a cloud-based environment. It features tools for collaboration, AI to enhance clinical trial efficiency, and comprehensive support for regulatory submissions. The platform offers real-time collaboration, a central repository for easy content access, and is designed for inspection readiness.
RegDocs365. Regulated content for life science
- 1. Accelerate Life Science Innovation TM with RegDocs365 RegDocs365 is a best-of-breed, regulated content and document management solution for life science companies hosted in an Audit Ready Compliant CloudтДв (ARCC) validated environment. Pharma, biotech, CROs and vendors can easily streamline workямВows in an FDA 21 CFR Part 11 compliant environment at any stage of drug development through commercialization - including discovery, clinical trials, regulatory submissions, and post market. RegDocs365's built-to-grow architecture increases eямГciencies through an intuitive interface and time saving functionality speciямБc to Life Science needs. Life Science BasicтДв A fully compliant, ready- to-use, cloud-based IT infrastructure streamlined for early-stage life science companies with pre-deямБned departmental folder structures and a corresponding governance plan to enable both internal and external contributors. The purpose built content management solution that supports compliance to EDMS, eCTD, eTMF, complex SPL, and global regulatory submissions. Life Science LaunchpadтДв Includes Life Science Basic, PLUS a suite of remote desktop and user support and user provisioning services. Take advantage of high-level security for any digital or mobile device including new desktop roll out and BYOD. Early-stage Solutions Support in-house and external teams with real-time collaboration and multi-authoring capabilities. Keep all content in one easy to search central repository. Internal and external stakeholders can now work in parallel on multiple projects in a compliant environment. Share and retrieve any content type with full version history; upload missing documents, track milestone progress, and streamline repetitive tasks through automated workямВows - all in real time. Increase productivity by quickly being able to locate and retrieve any content through metadata tagging, workямВow automation, and OCR. Collaboration & Content Management RegDocs365's intuitive eTMF means you are always in a state of inspection readiness. Start prepared and stay prepared with RegDocs365's intuitive eTMF which uses the latest DIA eTMF reference model version. Designed for inspection readiness, users can easily manage, categorize, track and store data from multiple sites and multiple studies. Dashboards designed to identify required and missing ямБles. SpeciямБc solutions to track multi-site functionality. Long-term document retrieval and sophisticated OCR capabilities allow for quick, accessible content to ensure future audit ready access or regulatory authority requests. Intuitive eTMF
- 2. ArtiямБcial Intelligence (AI), reduces repetitive and burdensome tasks and aims to facilitate better decision making during clinical trials. Through the application of AI, RegDocs365 generates actionable insights and drives clinical eямГciencies. Feature applications include automatic analysis of facial expressions; biomarker data analysis, deep phenotyping for precision medicine, merging of disparate data sources, and better match patient recruitment. Leverage the content within your documents utilizing AI techniques to gain valuable insights into the data you're normally collecting as part of your clinical and regulatory activities. ArtiямБcial Intelligence to Support Clinical Trials Through a series of work-in-progress libraries and EDM reference model libraries submission teams are able to develop their ямБnal content seamlessly and eямГciently. Streamline collaborative authoring, review, and approval features for easy compilation and regulatory submissions. Sophisticated EDM for Simplifying Submission Processing A one-click interactive solution expands clinical trial and investigator meeting ямВexibility in compliance to 21 CFR Part 11. CRO Voice and Video Workbench tools provides a virtual interactive clinical trial and investigator environment. Transforming digital clinical trials helps improve patient enrollment and involvement, aggregates data-collection in real-time and minimizes redundancies through streamlined tasks including scheduling, alerts, reminders, and more. Remote investigator meetings help fortify retention through on demand content, improves attendance and produces signiямБcant cost savings. Leverage Digital Clinical Trials RegDocs365 Solution Suite EDM eTMF Life Science Basic FDA Form 1572 | | | Clinical Collaboration Content Management Custom Solutions | | Up and running in weeks not months Highly scalable No IT support needed AямАordable Real-time collaboration Multi-level security Audit readiness Integrates with public cloud environments Why Choose Us About Us (833) 734-3627 RegDocs365.com RegDocs365тДв is a life science digital content and document repository solution hosted in an Audit Ready Compliant CloudтДв (ARCC), FDA 21 CFR Part 11 environment. Our comprehensive solution brings chaos into order; streamlines, manages, and future-proofs data; and delivers the single source of truth from author to archive.