Key Features/Benefits

  • Unified Patient Randomization, Drug Supply Management and ePRO
  • Seamless Integration with agClinical™ CTMS
  • Streamline SAE reconciliation through integration with ARISg™
  • Easily manage the most complex study designs
  • Reduces IT infrastructure and support
  • Intuitive User Interface
  • Advanced Data Management Tools
  • Configurable Study Design Module
  • Drag-and-Drop Design Wizard
  • Configurable Workflows
  • Comprehensive Validation Builder
  • Multi-lingual Support

Background

As the adoption of electronic data capture (EDC) has improved, EDC is now recognized as a commodity that is helping sponsors and CROs reduce costs while increasing efficiency and improving trial outcomes.  With many different solutions to choose from, the key differentiators are found in the level of service provided; time to study startup, flexibility to adapt during the trial, and integration with other systems such as randomization, supply, ePRO and CTMS.

LifeSphere EDC™ – Unified EDC

LifeSphere EDC is an innovative electronic data capture system that fully unifies EDC, randomization & trial supply management (RTSM) and ePRO with medical dictionary coding, CTMS and internal patient compliance modules.  Sponsors and CROs benefit from having a cost-effective way to capture, manage and report clinical research data regardless of trial phase and complexity.  This allows sponsors to deploy hybrid studies combining paper (supported by double data entry), ePro and EDC in a single unified database, eliminating the need for costly integration and reconciliation.  Further, LifeSphere EDC provides standard connectors based on CDISC ODM standards to support integration with any compatible CTMS allowing CRAs to plan and conduct monitoring activities more effectively, comparing planned enrollment figures and SDV activity with actuals delivered in real-time and easily monitor study progress.

LifeSphere EDC is accessed from a single sign-on portal that can be customized for your company, offering a comprehensive eClinical platform for study designers, investigators, CRAs and data managers.  Access to the system is controlled based on user privileges, which are study dependent. LifeSphere EDC is built on a single database layer and requires no additional software to be installed.  Because of its unique, state-of-the-art design and architecture, study development times are dramatically reduced and changes to live studies can be implemented without disrupting study progress.

LifeSphere EDC is a comprehensive web-based EDC system that enables sponsors of clinical trials to capture clinical trial data directly from the study site, eliminating the need for paper CRF collection and data entry. By providing site-based access, data is immediately available to the sponsor and enables more rapid data collection, faster database lock and support interim study analysis.  Integration with RTSM, ePRO, CTMS, medical coding and patient compliance modules makes it adaptive to suit any clinical trial.  Intuitive navigation makes it easy to access the extensive data management and reporting capabilities, a key requirement for any biopharmaceutical company and/or CRO.  With exceptional levels of site acceptance, it is deployed in a wide range of global studies in several languages and can also be easily integrated with LifeSphere RTMS, ArisGlobal’s trial supply management tool for randomizing subjects.

electronic data capture software for clinical trials