OrthoIllinois, Ltd

13 Years and 89 Fully Executed Clinical Research Studies Incorporating IP and Medical Devices in Rheumatology, Orthopedics, Surgery and Pain Trials


• Established in 2006, resulting in 89 sponsored studies using IP and medical devices

• 46% of OrthoIllinois physicians and surgeons participate in clinical research

• OrthoIllinois Research actively recruits and serves patients within a 100-mile radius reaching from Illinois to Wisconsin and Iowa.

• Currently running 16 sponsored studies and one investigator-initiated sponsored study serving 328 patients

• Twenty three independent research studies are headed by our medical providers for the ultimate goal of improving patient care.

• In the past two years, 17 research articles were published in medical journals by our physicians and surgeons.

• In collaboration with the University of Illinois College of Medicine, 11 research studies are coordinated by 16 medical   students to help train them to be physician researchers.

     *Principle Investigators: Over 30 publications. GCP trained with over 72 years of clinical research experience, combined

     * Coordinator Expertise:
            EDC: Axiom, iMedNet, iMedidata, OpenClinica and others
            e-Diaries: TrialMax Touch, TrailMax Slate, ePRO
            Central IRB: Advarra, NEIRB, WCG, WIRB
            IRT/IVRS: EndPoint, Impala, and more 
            Recruitment: Acurian, SubjectWell, StudyKIK, Praxis

     * Radiology and MRI: Experience using Bioclinica, Medical Metrix, Osmosis Software for transmitting images

     * CLIA-Waived research lab and Quest Diagnostics located on site

     * Clinical Research Director: Financial and regulatory oversight. Negotiated and fully executed 26 clinical trials contracts     
 

Information

Demographic Data

  • SITE INFORMATION 
  • Start year clinical research2006
  • Phases of clinical studiesPhase II, Phase III
  • Types of studiesBiologics, Drugs, Medical Devices
  • PopulationsAdult 18-64 yrs, Senior 65 yrs and over
  • SPECIFIC SITE INFORMATION 
  • Type of sitePart of a practice
  • # of employees involved in research9
  • # of investigators16
  • Number of studies last year10
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday
  • Extended office hoursYes
  • Dry iceYes
  • Blinded pharmacistYes
  • Dedicated monitoring spaceYes
  • Internet access for the monitorYes
  • Onsite laboratoryYes
  • Central laboratoryYes
  • Infusion capabilityYes
  • Shipping optionsFedEx, UPS
  • REGULATORY INFORMATION 
  • Contact for regulatory documentsLisa Foti
  • Regulatory phone number8158477078
  • # of days to turn around regulatory documents1 to 2 days
  • Type of IRB used by this siteCentral
  • Appropriate storage facilities for productYes
  • FINANCIAL INFORMATION 
  • # days to turn around budget and contract2 weeks to 1 month