Reduce the Cost and Risk of Clinical Trial Study Start-up

An in-house potential investigator database is often thought to be a prize collection of information, unique to a particular enterprise and to be jealously guarded. How often, though, are such databases kept up-to-date on a regular basis, have information on past investigator performance, are actually useful for new therapeutic projects or are even accessible by all?

Perhaps an investigator database should be acquired, maintained, integrated and used in a much more rigorous fashion such that real benefits can accrue from its use, especially for effective planning and rapid study start up purposes.

The Perceptive Solution

INVESTIGATOR is a highly flexible, web based, proven proprietary clinical Investigator System. At its heart is a large, sophisticated, unified data repository of potential clinical investigators which is combined with a decision support environment. The system helps enhance the value of data, which may already be held on investigator performance. Instead of passive historical reporting, dynamic lists are created to be discussed, shared, refined and used as the basis of blast fax and e-mails as well as for assessment visits.

INVESTIGATOR's data cleaning and import technology make it easy to securely upload and integrate existing investigator data and study performance metrics, making them instantly available across a global organization. The data cleaning functions cover such updating for standard punctuation, correction of data entry errors, inconsistent naming conventions, spillover text, buried information, duplicate matching, etc.

Once in place, data is stored in a secure Oracle database. This data is accessed by sponsor personnel using personalized profile forms, with company-specific metrics and demographic data being available as filters. Search and display tools foster corporate wide collaboration regarding potential clinical investigators. The INVESTIGATOR system supports direct integration and data transfer with existing commercial and custom clinical data management systems. Comprehensive evaluative metrics can be provided without any re-keying of data.

INVESTIGATOR is simple to install. Typically it takes a few weeks to get the system up and running.

Features

• Secure login - the system and data is installed behind the sponsor's firewall
• Extensive search functions that create shared lists, watch lists, clip lists, etc.
• Investigator lists can be sorted and viewed by a variety of parameters such as: certificates, studies, assessments, historical performance, patient populations
• Integration with Microsoft Excel, e-mail and group fax
• Investigators can be flagged with 'easy to distinguish' assessments
• Search and display parameters can be customized to your needs
• Sophisticated cleaning, matching and merging routines ensure that when your worldwide personnel search for a record, they retrieve one and only one investigator or research organization
• Unique data structure for relating investigators with their competencies
• Incorporated as a module to Perceptive's IMPACT™ solution
• Modules and metrics can be built to each client's and each user's specification

Benefits

• Confidence that you are using the right investigators in your study
• Conduct more efficient trials by:
  • Avoiding historically poor performing sites
  • Eliminating trial placement at sites with competing projects
  • Including investigators in your trial who have optimal profiles
  • Creating lists that you can manipulate and use to help set up your sites
• Build your investigator database with minimal resources:
  • Sites enter their own information using secure unique profiles directly on the Internet
  • Standard assessment profiles driven by your requirements
  • Provides a central company wide repository of clean and proprietary investigator and site data
• Improve relationships with your investigators through better information:
  • All authorized users access the same information
  • Information is standardized across the global enterprise
  • Pool the observations of staff members who do not know each other or who are not working at the company at the same time
  • Integrate with other applications (e.g. CTMS, IVRS, Quality Assurance) to help improve data consistency and workflow processes
  • Recruit patients faster. If the right sites are not selected, patient recruitment will not happen.