Web Content Management

PRODUCTS

  • Strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle through to post-approval.

  • Connect your entire operations across internal and external sites

    Product Lifecycle Data

    Consolidate data for each stage of a drug’s lifecycle in one place.

    • Expedite compliance by centralizing product lifecycle data for each stage
    • Shorten the time between one stage to the next
    • Streamline tech transfer and accelerate to commercial rollout

    Enterprise Recipe Management

    Optimize enterprise recipe management  across environments and sites.

    • Create and manage a core set of enterprise-wide templates
    • Get access to customizable resources for every stage
    • Easily assign your templates and resources to individual sites and teams

    External Manufacturing Collaboration

    Ditch email and calls for automated communications.

    • Grant direct view-only access and batch review options as needed
    • Provide customers with a self-service approach to their sponsored batches
    • Make real-time, data-driven decisions

    Tech Transfer

    Quickly and easily move all your master resources and data.

    • Securely store batch templates, procedures, materials and equipment classes
    • Easily share process knowledge and data through transferable global recipes
    • Shift a product ad-hoc from one team to another
  • Discover why more life science teams are using OpenClinica Unite™ to automate source data acquisition from patient medical record systems to clinical trial research databases and case report forms.

  • Delve into the details of this full-service global product development and strategic regulatory group that has a proven track record of successful FDA meetings and approvals.

  • There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.

WHITE PAPERS AND CASE STUDIES

NEWS