Operational Performance

Automate the manual, cumbersome and error prone processes and tools, not specifically built for study startup, for site selection, feasibility and activation in clinical trials.

With globalization and outsourcing expanding their footprints, improved study startup is essential for building speed into the clinical development process – streamlining a key bottleneck – allowing stakeholders to better adhere to established timelines and budgets.

Feature which manages country details

Shorten cycle times

There is intense pressure to speed clinical trials and restrain costs, but inefficiencies tied to complicated protocols, globalization, and paper-based methods have stalled these efforts.

  • Complete all site selection activities with integrated workflows
  • Reuse site profile and previous study data to pre-populate feasibility survey
  • Reduce number of non-active, non-enrolling (NANE) sites being activated for studies
  • Identify bottlenecks and avoid redundant processes
  • Drive data-based business decisions and set global milestones
  • View global study status across portfolio, anytime from anywhere
  • Speed study activation with 60+ "smart" standardized country workflows
  • Automatically trigger workflows as a clinical trial unfolds
  • Improve processes to drive optimization and global standardization
  • Track any activity, document, submission, or ad-hoc documents
  • Ensure appropriate activity access with role-based assignments

Continual reliance on standalone spreadsheets, multiple databases, and unsecured email without audit trails is inadequate to manage study startup activities, such as, country selection, pre-study visits, site selection and initiation, regulatory document submissions, contract and budget execution, and enrolling the first patient.

Facilitate global collaboration

Oversight is here to stay, but in the spirit of collaboration, it is most effective as a partnership in which all parties benefit – by enabling greater transparent and visibility into trial data. The intelligence gathered can improve study startup by helping clinical project managers identify bottlenecks, and take corrective action faster.

  • Regularly collaborate with sites, CROs and sponsors
  • Provide transparency into key study milestones and activity statuses
  • Provide a centralized view for all assigned study team members
  • Easily organize work with timely, appropriate activity assignment
  • Exchange documents, notes, complete activities, and monitor partners status

Successfully executed trials require open and transparent communications, fostering trust – shifting the focus from monitoring to better collaboration.

Bringing Speed to Study Startup
Oncology Study Startup Cycle Time Case Study
Using eClinical Systems to Speed Up Clinical Trials
Let's Talk