Overview

MediSphere is an independent, dedicated clinical research company that conducts phase 2 to 4 clinical research for pharmaceutical, biotechnology, nutritional and medical device industries. Founded in 1992, MediSphere has participated in more than 500 national and multinational clinical trials.

MediSphere has more than 25,000 active patient files in Evansville, Ind., the major city in the Tri-State area. The Tri-State, with a population of 1.2 million, is composed of 11 counties in southwest Indiana, nine in western Kentucky and 10 in southeast Illinois.

MediSphere is a member of the Alliance for Multispecialty Research (AMR), an independent site alliance of established, geographically diverse, professional clinical research sites. The Alliance is a not-for-profit support organization composed of 24 multitherapeutic, highly experienced research centers across the U.S.

Research Experience

On-Site Equipment/Services:

• Emergency Equipment: Crash Cart, Automated External Defibrillator
• Diagnostics: ECG, phlebotomy, Laboratory for Processing & Shipping Specimens, Pulmonary Function Testing (Puritan Bennett - 100), Doppler, Holter Monitoring & Ambulatory Blood Pressure Monitoring (ABPM) Capability, Mercury Sphygmomanometers
• Equipment: Refrigerator - Not Frost Free, -20° Freezer, Fax Machines, Dry Ice, Locked, Temperature Controlled Drug Storage, Centrifuge
• Services: Diet Counseling, Certified Clinical Research Coordinators, Remote Data Entry (Including Internet Access). Full time Physicians on site. Comprehensive SOP's (available on request), OSHA Compliant, CLIA Certified for Provider Performed Microscopy, FAA - Bio-hazard Certification. Compliant with GCP/ICH Guidelines for Informed Consent Process.

Available Services: Diagnostic Radiography, Ultrasonography, Computerized Tomography, Magnetic Resonance Imaging, Hologic DEXA, Body Composition Analysis, Exercise Treadmill Testing, Echocardiography, Nuclear Cardiac Imaging, Nuclear Imaging, Certified Vascular Laboratory, Renal Dialysis, Peritoneal Dialysis Urodynamics, Endometrial Biopsy, Ophthamology

MediSphere Medical Research Center, LLC, Industry Sponsors:

MediSphere Medical Research Center, LLC, Contract Research Organization (CRO) Sponsors:

Facility Description

Completed in early 2002, MediSphere is a state-of-the-art, modern medical research facility with 9,300 square feet. The following are available onsite:

Emergency Equipment

• Crash Cart,
• Automated External Defibrillator

Diagnostics

• ECG,
• Phlebotomy,
• Laboratory for processing and shipping specimens,
• Pulmonary function testing (Puritan Bennett - 100)
• Doppler
• Holter monitoring and ambulatory blood pressure monitoring (ABPM) capability
• Mercury sphygmomanometers

Equipment

• Refrigerator - not frost free
• -20° freezer
• Fax machines
• Dry ice
• Locked, temperature-controlled drug storage
• Centrifuge

Available services

• Diagnostic radiography
• Ultrasonography
• Computerized tomography
• Magnetic resonance imaging
• Hologic DEXA
• Body-composition analysis
• Exercise treadmill testing
• Echocardiography
• Nuclear cardiac imaging
• Nuclear imaging
• Certified vascular laboratory
• Renal dialysis
• Peritoneal dialysis urodynamics
• Endometrial biopsy
• Ophthalmology

FDA audits in October 1999, May 2001, September 2006 and November 2008 showed no deficiencies and no 483's issued.

Investigator Experience

Hubert S. Reyes, MD

Dr. Reyes is certified by the American Board of Family Practice. He holds the following certifications: Pediatric Advance Life Support (PALS), Basic Cardiac Life Support (BCLS), Advance Cardiac Life Support (ACLS) and Advance Life Support in Obstetrics (ALSO).

Alexander Dela Llana, MD

Dr. Dela Lana is certified by the American Board of Family Practice. He has more than nine years' experience in clinical research trials and has participated in over 300 studies.

Mike Sebastian, MD

Dr. Sebastian is certified by the American Board of Family Practice. He has nine years' experience in clinical research trials and has participated in more than 300 studies.

Mary "Sammie" Rutherford, RN, BSN, MSN, FNP

Ms. Rutherford is nationally certified by the American Academy of Nurse Practitioners with more than 25 years’ experience in advanced practice and over 10 years’ experience in clinical research

Staff Expertise

John Wathen, B.
Chief Operating Officer

Primary Investigators

Alexander E. Dela Llana, MD

Hubert S. Reyes, MD

Mike Gerald A. Sebastian, MD

Sub Investigators

Mary "Sammie" Rutherford, RN, BSN, MSN, FNP

Steven K. Elliott, MD

Administrative Staff

Kim Dwojak
Operations Manager

Lesa Woodruff, BS
Contracts Administrator

Perla Dela Llana
New Business Development

Clinical Research

Carrie Covert, BS, CCRC
Manager, Clinical Studies

Lene Grace Nibungco, MD
Recruitment Manager

Aaryn Clayton
Clinic Research Coordinator

Maribel N. Nuestro BSN, PBT (ASCP-CM)
Clinic Research Coordinator

Sherri Scheller, BS
Clinic Secretary

Ted Nora, BS
Data Entry Coordinator and Regulatory Assistant

Regulatory Department

Anna Bruggenschmidt
Regulatory Affairs Administrator

Patient Demographics

Our patients come from southwest Indiana, western Kentucky, and southeast Illinois. The population is relatively stable and non-transient. MediSphere selects patients who are reliable and compliant with medical regimens. We have more than 26,000 patient profiles in our computerized patient tracking system.

Other Information

Services

• Diet counseling
• Certified clinical research coordinators,
• Remote data entry (including internet access)
• Full-time physicians onsite
• Comprehensive SOP's (available on request)
• OSHA compliant
• CLIA-certified for provider-performed microscopy
• FAA biohazard certification
• Compliant with GCP/ICH guidelines for informed consent process