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Clinical Study Insight

Your Complete End-to-End Clinical Study Management Solution
An integrated cloud-based platform that addresses the needs of a busy team of researchers. Recruit, track, collect clinical research data, analyze and draw data-driven insights for your complex clinical studies.
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Complexities of Clinical Research
Cost and Schedule Adherence

Most clinical research projects are funded by grants, which means a limited technology budget and time limits to complete the study.

Burden of compliance
In addition, most research studies must follow specific protocols and maintain compliance with standards and regulations, including those required by HIPAA.
Retention of Participants
Interacting and retaining participants for the duration of the study is difficult in rural areas and large-scale studies.
Participant data protection

It is important for study administrators to have easy access to study metrics and data, but participant data must be protected and kept confidential.

Paper Intensive Process
It’s been estimated that approximately 85% of complex studies are still managed on paper.
Data Confidence
Ensuring the integrity of data, protocol adherence and consistent processes are a struggle for multi-site study teams.
Top reasons for using a Proven Product Platform for Clinical Research Studies
Set up your study to match the protocol — and use the dashboards to track progress.
Technology
  • Cloud based SaaS application
  • Multiple architecture configurations to support single study, multi-study and enterprise needs
  • iOS and Android mobile apps for patient/participant electronic data capture and communication
Key Features
  • Role based login for all study investigators, clinicians, site coordinators
  • Supports single, multiple and global site studies
  • Single arm or multiple arm (i.e. intervention and control) treatment workflows
  • Eligibility screeners and registration forms allow automatic study enrollment
Integrations
  • Interfaces with popular third parties, including SurveyGizmo and Twilio
  • HL7 integration to EMR (Electronic Medical Record) systems
  • Integration to third party Allscripts
Data Analytics
  • Integrate with powerful data analytics tools 
  • Export study data into Microsoft® Excel® for further research
  • Get a real-time view of study health and retention
  • Visualize your data at multiple levels
  • View metrics from the study protocol and trends
Includes surveys, quizzes, informational screens and videos
  • Electronic capture of outcome data
  • Export status of all protocol activities
  • Logs of all text, email and in-app communication
  • Capture lab results
  • Supports external content management portal
Intuitive Interface
  • Custom branding and themes
  • Add/remove staff members by role
  • Manage custom fields
  • Add study documents
  • Edit/add message templates
  • Add/update site profiles
Data Recording and Security
  • Records retention from disparate sources
  • Can handle huge volumes of clinical data
  • Clinical records maintenance for better visibility
  • Participant records privacy and integrity
  • HIPAA compliant—user anonymity guaranteed
  • Audit trail of communication
Benefits of Clinical Study Insight
On-time and On-Budget Clinical Research Projects
Study Setup
  • Configure your study based on the approved protocol
  • Add sites
  • Build study timeline
  • Upload your own logo and customize branding

Standard activities include:

  • Survey(s)
  • Visits—in person or telemedicine
  • Tasks
Study Management

Follow participants and their activities.

  • Add/remove staff/team members
  • Add roles and permissions
  • Manage custom fields
  • Add study documents
  • Edit/add message templates
  • Add/update site profiles
  • Set up reminders and notifications
  • Collect notes, communication and activity logs in common portal
Participant Interaction
  • You screen potential participants for eligibility
  • You enroll and assign participants to study arm through the management portal
  • Participant downloads app from iTunes® or Google Play
  • Participant interacts with study team and clinicians through the mobile app
  • Participant completes surveys, sends and receives messages and views informational content through the mobile app
Participant Onboarding

Setting up your study, onboarding participants and managing the study can be a challenge. Pair that with multiple study sites, and the management of this critical process can seem overwhelming. Keep participant engagement high with our iOS and Android™ mobile apps for activity reminders, personal messages and relevant content. Focus the available content to participants based on their study arm and progress in the study protocol. Your study team can watch participant progress with the management portal dashboards—and anticipate issues before they happen.

Participant Information
  • View timeline
  • Communicate via email, text or add a phone log
  • Receive status updates
  • View running list of recent activities
Profile Screen Information
  • Contact information
  • Notes
  • Labs
  • Custom fields
  • Documents
Clinical Study insight
Schedule a Free Demo
With Softura’s Clinical Study Insight, managing your Clinical Trials is easier and more efficient.
Calendar Management
  • Set up calendar for managing visits or video conferences during the study setup process
  • Include visit/video conference appointment types in calendar management
  • List staff members available to host the visits or appointments on calendar
  • Staff members make themselves available for appointments in their calendar management
  • Participants can select the appointment from the mobile app
  • Site staff can book an appointment on behalf of a participant
  • Email confirmations are sent to both staff member and participant
  • Cancel/reschedule appointments up until the appointment time
  • Drag an appointment type onto the calendar to create an appointment
  • Set up recurring appointments based on date and number of occurrences
  • Establish appointment duration in the appointment type setup
  • Access high-level study metrics based on the protocol
  • Click through to participants from the metrics in the timeline summary
  • View a log of all recent activities
  • Manage calendar events
  • View/upload study documents and reference material
  • View all participant planned activities
  • View participant status
  • View and manage study status
  • Communicate with participant and view all communication history
  • View participant profile information
  • Add ad-hoc tasks for participants
  • Add/modify/cancel study team visits
Partnering for Success
Trusted by Leading Research Organizations
We understand the business processes in the clinical and research setting and have built applications to address the pain points of our customers.
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