To help advance the efficiency and compliance of getting your product to market, our Global R&D Operations team provides experienced Subject Matter Experts to support your day-to-day required activities, including:

Global Submission Management

The Red Nucleus team offers flexible capacity with strong, proven capabilities to deliver compliant regulatory submission deliverables:

  • Successful Leadership/Publishing of Global Submissions
  • Successful Management/Delivery of Global Life Cycle Submissions
  • Guidance Interpretations and Document Authoring Support
  • Submission-Ready Document Preparation
  • Guidance/Management of Structured Product Labeling (SPL) Outsourcing

Publishing

Successful publishing of global submissions relies on a deep understanding of the document life cycle and global submission requirements. The Red Nucleus R&D Operations team provides

  • Document QC and Readiness Services
  • Paper, Electronic, eCTD, and NeeS Submission Deliverables
  • Cross-Referencing and Hyperlinking Strategies
  • CTD Granularity Guidance
  • Knowledge of ICH and Global Data Standards

Medical Writing

We partner with clients to develop and finalize the required regulatory documents that support drug, biologic, and medical device marketing applications to regulatory authorities, including:

  • Protocol (Synopsis & Amendments)
  • Informed Consent
  • Clinical Study Reports (CSRs)
  • Annual reports
    • Periodic Safety Update Reports (PSURs)
    • Development Safety Update Reports (DSURs)
    • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Clinical Investigator Brochure
  • Integrated Summary of Safety/Efficacy

Technical Project Management

Our Project Managers have worked with content management, publishing, and registration tracking systems. They are adept at providing project oversight while engaging cross-functional stakeholders.

Based on this experience, we have optimized the practical use of the following systems:

  • Content Management Systems
    • Veeva RIM Suite
      • Vault Registrations
      • Vault Submissions
      • Vault Submission Publishing
      • Vault Submission Archive
    • Veeva Clinical Suite
      • eTMF, CTMS
    • Veeva Quality Suite
      • Vault QMS
      • Vault QualityDocs
    • Veeva Vault PromoMats
    • Documentum (EMC2)
    • FirstDoc (CSC)
    • SharePoint (Microsoft)
    • GLS (Glemser)
  • Publishing Systems
    • Insight Publisher (Liquent)
    • eCTDXpress (CSC)
    • Extedo
    • GlobalSubmit Publish
    • DocuBridge (Lorenz)
  • Registration Tracking Systems
    • Insight Manager (Liquent)
    • TRS Tracker (CSC)
    • Trackwise (Sparta Systems)
    • ArisGlobal
    • Drug Track (Lorenz)

Risk Management & Compliance

Our R&D experts are committed to ensuring and maintaining successful programs through monitoring, tracking, and reporting. To this end, we focus on delivering measurable benefits:

  • Dashboards
  • KPIs, Metrics
  • SOPs, Work instructions