Key Features/Benefits

  • Reduces the time and cost of site and investigator management
  • Enhances patient recruitment by enabling faster, more efficient site selection and initiation
  • Fosters greater collaboration between investigators and sponsors
  • Boosts site staff productivity
  • Assures investigators they are in receipt of timely, important information
  • Exchanges documents between sponsor and investigators electronically
  • Manages the sponsor and investigator trial master file (TMF)
  • Automates the secure distribution of SUSARS at significantly reduced cost
  • Investigator self-registration functionality
  • Role-based dashboard for viewing/access TMF-related documents and clinical trial information
  • Secure document management and eTMF functionality
  • Library of templates enable site feasibility questionnaires to be easily generated and scored
  • Automated Safety letter distribution
  • Configurable training management modules
  • Online chat
  • Hosted Cloud-based deployment

Background

Investigator sites personnel are often frustrated with the lack of transparency and communication with their sponsors, leading to dissatisfaction and often withdrawal from current and future studies.  The emergence of investigator site portals now provides sponsors with a platform that fosters collaboration and improved site management, all of which enables organizations to ensure global compliance and reduce costs.

LifeSphere Investigator™ - Site Investigator Portal

LifeSphere Investigator is an investigator site portal that facilitates and streamlines the communication and collaboration between sponsors and their investigator sites. In addition to site staff, LifeSphere Investigator can be accessed by any third-party personnel, including CROs, IRBs and ethics committees.

LifeSphere Investigator centralizes access to all critical trial data and documentation, helping sponsors to reduce the time, cost and effort of managing study sites while giving investigators the confidence and assurance they are in receipt of necessary information.  From an intuitive dashboard, study site staff are provided with role-based access to information including TMF-related documents, training modules and records, feasibility questionnaires, and safety reports. Investigator self-registration enables sponsors to receive a steady flow of interested participants while improving relationships with existing investigators.

Secure document management and eTMF functionality ensures all critical trial information is exchanged. Automated safety report distribution reduces manual efforts and associated costs of ensuring compliance with timely SUSAR notifications. Streamlined site assessment and selection is achieved through the use of templates, which enable sponsors to develop, distribute and manage study-specific electronic feasibility questionnaires used in the review of recruitment and retention strategies. Site monitors utilize configurable training workflows to maintain site personnel records, including the training provided to each person.

clinical safety solution software