Electronic Data Capture

As the costs of clinical studies rise, and the demand to quickly deliver therapies to market intensifies, renewed emphasis is placed on technology solutions such as Electronic Data Capture (EDC) to control operational costs and expedite time-to-market. By capturing data electronically, and storing the data in advanced databases, key clinical constituents—investigators, sponsors, research organizations and regulatory agencies—can gain access and visibility into study data sooner for earlier insight into the conduct of studies. In turn, earlier insights enable study decisions to be made in a timely manner during the clinical development cycle.

Advanced EDC technology incorporates streamlined study design, workflow, discrepancy management, coding, integration standards, regulatory compliance, and extensive reporting and analysis into the overall solution. Phase Forward’s InForm™ Global Trial Management (GTM) system delivers all of this functionality in an award-winning EDC solution that has already been used successfully in over 3,000 trials worldwide.

 


An Environment Designed for Today's Global EDC User

Using the InForm GTM product’s intuitive interface and streamlined workflow, clinical research coordinators, trial monitors, clinical data managers and project managers can work more efficiently and with greater accuracy. The InForm GTM advanced reporting and analysis tools are designed to enable sponsors to view and act on data earlier in the trial development cycle and manage study procedures and expenditures more effectively. Integration with modules for randomization and trial supply (Clarix™), trial design (Central Designer™), and medical coding and dictionary management (Central Coding™) provides a comprehensive electronic clinical data management (eCDM) solution. Leveraging the InForm GTM product’s proven track record for scalability and ease-of-use, organizations can rest assured that when conducting trials of any type or size this flexible EDC solution will accommodate their global requirements.

Proven Usability

  • Intuitive, workflow-based interface designed to maximize user efficiency
  • Roles-based functionality helps organizations streamline workflow
  • Extensive query management processing features enables efficient discrepancy resolution
  • Standard-and user-driven reporting provides real-time data visibility

Trusted Performance and Scalability

  • Used in over 3,000 trials worldwide across more than 50 therapeutic areas
  • Tiered system architecture designed to support trials of all types and sizes

Flexible System Configurability

  • Streamlined trial design and setup through regulatory submission
  • Simple and reliable connections to third-party systems such as IVRS, CTMS, ePRO and Imaging
  •  Available as a point system or as a comprehensive eCDM solution

World-Class Delivery and Support

  • Service Professionals with extensive domain experience can meet the requirements of any size organization
  • Global 24x7 multilingual support available

Commitment to Standards and Industry Regulations

  • Support for CDISC and other standards
  • Full support to enable compliance with GCP, 21 CFR Part 11 and other regulatory guidance