Overview

InSpire is PharmaVigilant's fully-integrated Electronic Data Capture (EDC) system, designed to address the evolving complexities of clinical development.  Bringing together best-in-class technologies, InSpire supports the needs of both the industry and end-users throughout the entire clinical development process.

 

How InSpire Will Revolutionize the Way Your Trial is Conducted

InSpire incorporates industry-leading features into its fast, secure, and user-friendly interface. InSpire's superior, flexible  functionality enables clients to incorporate any form design which includes complex edit checks, dynamic forms, and dynamic visits, IWRS, auto-coding functionality, lab import utilities, and a complete safety system.  Furthermore, InSpire links directly to our Clinical Data Warehouse, which enables multiple trials to be imported, exported on demand, and analyzed across trials.

InSpire's integrated approach eliminates the additional costs of separate systems and the time and cost of reconciliation across databases.  It also ensures fast study start up and data lock by providing unique, role-specific work flow tools which ensure that sites can enter and review data with minimal training and follow up.  This is enhanced by customized study tabs with up to the minute information on enrollment, data entry, data monitoring, sign off and data lock.

InSpire can be accessed through PharmaVigilant's custom branded web portal.  InSpire's web-enabled interface supports all versions of Mozilla Firefox, Internet Explorer, Chrome and Safari web browsers. 

 

Multiple Features, One System

InSpire EDC's robust functionality includes:

• Auto coding within InSpire includes development of a knowledge base that can be used within a study and across studies for a specific compound.  This knowledge base enables the Sponsor to have coded terms for the SAEs immediately accessible for the regulatory submissions.  In addition, the knowledge base assures that the coding is consistent across the entire trial or program. PharmaVigilant can manage multiple versions of MedDRA or Who Drugs across trials.
  
  
• Randomization - PharmaVigilant uses sophisticated Interactive Web Response Systems (IWRS) to effectively screen and randomize patients and manage study drug inventory.
  
  
• Common AE/SAE database - PharmaVigilant provides a common form for both adverse events and serious adverse events.  This assures that the data in both databases is the same, saving time and resources. As Con Meds are also linked to the instance, AE/SAE reconciliation is eliminated with our system. Con Meds are linked to the AE/SAE events. Exports from the common database can be provided if the Sponsor has a separate safety system.
  
• Automatic notification of SAEs - PharmaVigilant provides Sponsors and their safety teams with automatic email notification of serious adverse events. The date and time are documented within the audit trail. Notification includes information on the study and the patient. Sponsors and their safety teams are also notified when there is any change to the data on SAE forms.
  
  
• Clinical Data Warehouse (I-Warehouse) is provided free with the use of InSpire. PharmaVigilant's I-Warehouse is the industry's first commercially-available data warehouse, which provides analytics across multiple trials allowing faster trial close out and data-on-demand.
  
  
• Pre-populated MedWatch or CIOMS forms provide the fastest and most complete approach to meeting regulatory requirements.  Data that have already been entered within the EDC are pre-populated on the MedWatch/CIOMS forms.  This assures that the data is accurate and eliminates the need for reconciliation.  These forms are generated in PDF format for submission and distribution as needed to regulatory and IRBs. MedWatch or CIOMS forms can be regenerated when additional data is provided or there is a change in the data.
  
  
• Lab imports - PharmaVigilant imports lab, ECG results, and ePRO (electronic patient reported outcomes) data to assure that the Sponsors and their safety teams have all the information they need to fully assess the safety of the compounds and to meet their regulatory reporting requirements.
  
  
• Flow control - Our robust flow control turns on and off questions based on specific responses by the site, ensuring that sites only answer pertinent questions.
  
  
• Single password-protected portal - PharmaVigilant provide password-protected portals to enable the Sponsor to build their relationship with their physician investigators. Once a user enters via the portal they can transfer to other systems, without having to log back in.
  
  
• Custom Design/Branding - PharmaVigilant can brand each study by adopting a logo, color scheme, images, and other visual elements that will differentiate each study from others in the market. This is important for clients that want to establish brand identity either in Phase III or IV, post - marketing studies.

 

Trusted Across the Globe

InSpire is a fully validated, 21 CFR Part 11 compliant system. It has been deployed in over 80 studies in 18 countries in North America, Europe, Eastern Europe and Asia in all phases of development, and has over 200,000 patients enrolled in the system.