InSite Patient Management System; a Clinical Trial Recruitment and Management Tool

2004-9, Chesapeake Editorial Consultants (CEC)/Real Interface Expert Systems (RIES)/ Pharmatech Solutions/ InClinix

Project Summary | My Role | Highlights

Project Summary

Originally a web-based application for mobile (palm-pilot use), InClinix was invented in 2004 to enable Investigators at Research Hospitals to quickly screen patients against multiple clinical trials. The goal of the tool was to quickly exclude patients, thereby reducing the number of screening questions.  Clinical trial protocols were analyzed and a questionnaire designed to screen the patient based on the trial criteria.  These criterion were then aggregated with those of other trials, with shared criteria being asked first, and unique questions then being excluded once a patient was not qualified for participation, thereby reducing the number of questions typically asked when a patient was screened against each trial separately.

It was purchased by a Clinical Trial Recruitment company, PharmaTech Solutions, who saw the potential to adapt the technology for use in the call center environment. PharmaTech Solutions purchased Realinterface Expert Systems, taking the product name (InClinix) as the newly merged company’s name. I became an employee of InClinix and was tasked with adapting InClinix, as “InSite” for the call center environment.

InSite became an end-to-end enterprise solution that tracked call center activity,  screened patients, captured patient, customer, and protocol data for analysis, tracked the recruitment lifecycle, and provided a portal for pharmaceutical sponsors and patient investigator sites.  Pharmaceutical sponsors could view enrollment progress for each site and across all sites.  Site users also had access and could log on and disposition patients.  

My Role

  • Brought application to market.  I was part of the original ideation team, I lead the research and design of the product, and later, supported the sales and marketing efforts, and lead customer implementations.
  • Re-engineered Application for Enterprise Application in Call Center. Used Agile, JAD development techniques to quickly adapt an existing Dot Net application to meet call center, clinical recruitment space. Performed business analysis, created requirements, use-case scenarios, designed new interfaces, redesigned reports, create data diagrams, collaborated to redesign SQL Server Database. Developed new core algorithm and logic flow with the lead engineer. Served as program manager: set build schedule, managed releases, trained users.
  • Supported  Sales, Marketing.  Interfaced with clients, acting as subject matter expert and project manager of all technology implementations. Oversaw training materials and help documentation. Performed webinars and live training sessions of end users.
  • Standardized & Documented SDLC Activities to conform to HIPAA, 21 CFR-Part 11, TQM standards. As R&D QA Officer, teamed with Chief Scientific Officer to create SOPs for the technology R&D team. Performed Audit preparations, defined and defended policies. Trained staff on policies & procedures. Performed regular updates/reviews of all corporate SOPs.
  • Enforced Quality Control Measures. Created test plans, oversaw QA of all R&D technology products and implementations. Developed a QA team, wrote test scripts, actively tested as needed.

Highlights

  • Successfully  re-engineered the InClinix product to an operational enterprise system within five months.
  • My efforts to align and document our SDLC processes to regulatory requirements resulted in a relationship with PRA International and a $1.2 million recruitment contract.
  • I developed a proto-type (using JIRA) to demonstrate the power of integrating InSite with current and historic project and client data (from 7 silo-ed systems and countless spreadsheets); that convinced leadership to investment in a development using SalesForce  (Force.com Apps).
    • Reduced effort of data collection for proposals by >90%.
    • Streamlined operational activities, reduced tracking/management efforts by  >80%
  • My support of the sales team (providing operational perspective, historical supporting data, and product and technical expertise)  led to the largest single sale in company history, $4 million.

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