Center Overview

Mission Statement

To provide flexible, superior quality, global pharmaceutical development services, that enable clients to expedite development, reduce costs, and establish the benefits of treatments that enhance people’s lives.

Background

Healthcare Discoveries Inc. was founded in 1994. Dennis A. Ruff, the Medical Director, has been in clinical research for over 20 years during which he has been involved in over 300 clinical studies. We are a full time research center conducting about 30-40 studies per year. We are a staff of 60+ including 3 full-time physicians.

Clinical Research Experience

We conduct Phase IA, I, and IIA clinical research studies. Various types of studies have been conducted at Healthcare Discoveries Inc., including experience with thorough QTc and other cardiac services, first in human, pilot, single and multiple dose escalation, PK, PD, bioequivalence, food/drug interaction, MTD, ethnicity effects, age/gender, intravenous infusion testing, and renal impaired.

In addition, we have access to over 300 dialysis patients (GFR <15); approximately 700 pre dialysis subjects (GFR 15-30) ; 2000 patients with moderate impairment (GFR 30-60); and 1500 patients with mild impairment (GFR 60-90). Our subject database of over 5000 healthy/normal, and other special populations, such as Type I and II diabetics, glucose intolerant, obese, and ethnic population (e.g. Spanish, Indian, and Japanese), can accommodate rapid enrollment for most any Phase I study design.

Our physicians at Healthcare Discoveries, Inc. excel at complex pharmacology studies that require difficult diagnostic procedures (e.g. Glucose Clamping, EEG studies, gastric and esophageal pH monitoring, esophagogastroduodenoscopies, etc.) and time sensitive sampling.

Highlights include:

• On-site pharmacy and pharmacist
• On-site CLIA and COLA certified laboratory
• eCRF (EDC)- sponsor involvement in eCRF design
• Central IRB (1 week turn-around)
• Recruitment department and toll-free call center (Hotline: 877-848-7425) [Special population (disease and healthy)]

Our sister company, Catalyst Pharmaceutical Research, LLC, is a full service CRO that can provide data management, statistical support, medical writing, monitoring, and more. See Catalyst website for more details: www.catalystpharmagroup.com

We can speed both the initiation and completion of your Phase I research because our Phase I facilities are part of the Catalyst Pharma Group (CPG) family. Together, Healthcare Discoveries and Catalyst provide the perfect foundation for accelerating clinical development and a smooth transition from Phase I to Phase II through Phase III clinical studies. With over 10 years experience in all phases of clinical research, across the spectrum of medical science, we have designed our Phase I operations to provide the most professional, confidential, and secure environment possible to protect both the subject’s and client’s interests.

Client List
Healthcare Discoveries Inc. has worked with the following Sponsors and CRO's:

Facility Description

We have a dedicated Phase I facility focusing on Phases I-IIA and trials requiring in-patient visits.

Key Features:

• Atomic clock time to ensure continuity and adherence to protocol-specific time-points
• Located within 3.5 miles of tertiary care hospital
• Two facilities: 13,000 square foot + 43,000 square foot
• 150 bed capacity with semi private rooms
• Recreation and dining rooms
• Dedicated phlebotomy area
• Security controlled

Laboratory

• COLA/CLIA certified
• Olympus 400 chemistry analyzer
• Pentra with 5 part differential CBC
• Clinitek UA
• On-site urine drug testing
• Chronolog whole blood platelet aggregometer
• Three -80° freezers and two -20° freezers (secured and monitored)
• Refrigerated centrifuges
• 24 hour generator back-up support
• LIS system – CFR part 11 compliant
• Data load transfer capability
• PK prep area

Pharmacy

• Secured limited access
• Biological safety cabinet / Clean air device (Pharmacy Hood)
• Capable of drug reconstitution
• IV pumps for medication delivery
• Accommodations for controlled substances
• Secured and monitored refrigerator and freezer
• Generator back-up support

Staffing

• 24-hour staffing
• Well trained and qualified personnel
• Medical Director with 17 20+ years clinical research experience
• Three full-time physicians on staff (each with 10+ years research experience)
• Registered and licensed nurses, medical assistants, phlebotomists, and lab technicians
• ACLS certified
• Dedicated and experienced project coordinators
• CCRC and CCRP certified
• Flexible Data Entry department
• Full-Time Pharmacist
• Registered Dietician
• QA/QC Team
• Recruitment
• IT support

Investigator Experience

Dennis A. Ruff, M.D., Medical Director, President

Specialty: Internal Medicine

Education:

Doctor of Medicine
Albany Medical College of Union University
Albany, NY 1982

Lafayette College
Easton, PA 1974-78

Boards:

National Boards Part I, II, & III Passed 1980-83
FLEX Part II, Passed 1985

Credentials:

Certification - American Board of Internal Medicine 1985 Licensed

Research Experience Summary:

• Duration: Over 20 years
• Clinical Trials Conducted - over 300
• Phases: I-IV
• Principal Investigator on studies covering healthy volunteers, and diseased population including: hypertension, diabetes, OA, CHF, CAD, lipids, MI, AFIB, COPD, IBS, PVD, dyspepsia, erosive esophagitis, pain, and several others

Positions:

• Medical Director, Catalyst Pharma Group, CRO and clinical research site, 2004-present
• Medical Director, Healthcare Discoveries, San Antonio. clinical research site, 1994-present
• Research Physician, South Texas Clinical Trials. A clinical research site, 1985-1994
• Solo Practice, San Antonio, 1988-present
• Southwest Medical Group, San Antonio, 1985-87
• Residency and Internship in Internal Medicine, Allentown Affiliate Hospitals, 1982-85

Appointments:

Chairman, Pharmacy and Therapeutic Committee, San Antonio Community/Regional Hospital, 1996-98; Member 1994-95
Member, Bioethics Committee, San Antonio Regional Hospital, 1993-94
Chairman, Dept. of Internal Medicine, Humana Hospital, San Antonio, 1990
Chairman, Joint Bioethics Committee, St. Luke’s & Methodist Hospitals, 1988-89

Academic:

Clinical Professor, Dept. of Medicine, University of Texas Health Science Center, San Antonio, TX - Current

Awards:

From a site management organization:

• Excellence in Research, 1997
• Management Award, 1997

Publications:

Ten research publications

Emanuel DeNoia, M.D., Vice President

Specialty: Internal Medicine

Education:

Doctor of Medicine
College of Medicine of New Jersey
Newark, New Jersey - 1975

Credentials:

Eligible - American Board of Internal Medicine 1975 Licensed

Research Experience Summary:

• Duration: Over 10 years
• Clinical Trials Conducted: over 175
• Phases: I-IV
• Clinical Investigator on studies covering healthy volunteers, and diseased population including: hypertension, diabetes, OA, CHF, CAD, lipids, MI, AFIB, COPD, IBS, PVD, dyspepsia, erosive esophagitis, pain, and several others

Positions:

• Research Physician/Clinical Investigator, Healthcare Discoveries, Inc., San Antonio clinical research site 1995-present
• Solo Practice, San Antonio 1979-2005
• Solo Practice, Shrewsbury, New Jersey 1978-1979
• Residency, Internal Medicine, Monmouth Medical Center, Long Branch, New Jersey 1976-1978
• Internship Internal Medicine, Monmouth Medical Center, Long Branch, New Jersey 1975-1976

Appointments:

Associate Attending Monmouth Medical Center, Long Branch, New Jersey 1979

Hospital/Professional Affiliations:

San Antonio Community Hospital, San Anotnio, TX 1981-present
St. Luke’s Lutheran Hospital, San Antonio, TX 1981-present
Southwest Texas Methodist Hospital, San Antonio, TX 1981-present
Associate A.C.P.
Texas Medical Associate
Bexar County Medical Society
Board of Directors, San Antonio Regional Hospital
Head of Internal Medicine, San Antonio Regional Hospital
Membership Committee, St. Luke’s PHO, San Antonio, TX

Medical Director:

Christus Santa Rosa Hospice, San Antonio, TX present
Vistacare Hospice, San Antonio, TX 1995-2006
Four Seasons Nursing Home, San Antonio, TX
Lytle Nursing Home, Lytle, TX
Northgate Manor Nursing Home, San Antonio, TX

George Atiee, M.D.

Specialty: Family Practice

Education:

Doctor of Medicine
U.T. Health Science Center
San Antonio, TX 1981

Credentials:

Certification - American Board of Family Practice 1988 Licensed

Research Experience Summary:

• Duration: Over 10 years
• Clinical Trials Conducted: over 90
• Phases: I-IV
• Clinical Investigator on studies covering healthy volunteers, and diseased population including: hypertension, diabetes, OA, CHF, CAD, lipids, MI, AFIB, COPD, IBS, PVD, dyspepsia, erosive esophagitis, pain, and several others

Positions:

• Research Physician/Clinical Investigator, Healthcare Discoveries, Inc., San Antonio clinical research site 2005-present
• Research Physician/Clinical Investigator, Sun Research Institute, San Antonio clinical research site 1995-2003
• Private Practice, San Antonio, TX 2000-present
• Family Practice Physician, WellMed, San Antonio, TX 1999-2000
• Family Practice Physician, Cinnamon Creek Medical Group, San Antonio, TX 1993-1999
• Family Practice Physician, Trinity Medical Group, San Antonio, TX 1991-1992
• Residency, Baylor College of Medicine, Houston, TX (Co-Chief Resident third year of residency) 1986-1988
• Internship, Baylor College of Medicine, Houston, TX 1985-1986

Military Experience:

Air Force Active Duty 1980-1991
Chief of Primary Care Clinic, Randolph Air Force Base, San Antonio, TX

Medical Societies:

Bexar County Medical Society
Texas Medical Association
Texas Academy of Family Physicians
American Academy of Family Physicians

Patient Demographics

San Antonio, Texas, area has a population of about 1.2 million. Per the Wikipedia the eight-county metropolitan area has a population of over 1.8 million. San Antonio is the second-most populous cioty in the state of Texas after Houston and seventh-most populated in the United States. San Antonio is home to 12+ major universities and community colleges and the largest concentration of military bases in the United States. Racial make up of San Antonio consist of 64% White, 61.% African American, 1.8% Asian, 0.7% Native Americna; 61.2% of the population is of Hispanic origin and could be of any race. The population is spread out with 28.5% under the age of 18, 10.8% from 18-24, 30.8% from 25-44, 19.4% from 45-64, and 10.4% who are 65 years of age or older. The median age is 32 years. In San Antonio, 48% of the population is male, and 52% of the population is female.

Other Information

• Healthcare Discoveries Inc. uses IntegReview Ethical Review Board, a central IRB that conducts weekly board meetings and provides quick turnaround a central IRB on all studies.
• Our staff is experienced both in remote data entry and in electronic data capture (EDC) technologies through commercial and proprietary platforms
• Healthcare Discoveries has an alliance with OmniComm Systems, Inc. for the development of eCRFs using the TrialMasters system
• Our company has a 24/7 IT support team that ensures CRF Part 11 compliance
• Ongoing training and development guarantees qualified staff perform procedures
• QA/QC program to evaluate processes/procedures, ensures compliance with 21 CFR, ICH GCP guidelines, study protocol, company SOPs and initiate quality improvements to ensure on-time delivery of quality study results
• Our QA department maintains comprehensive training records on all clinical/research staff
• QA Vendor Audit program
• Computerized database of healthy volunteers
• Full cardiac monitoring and assessment via ECG Telemetry – 8 channels with 24 hour disclosure (GE Patient Net System)
• Strategic alliance with regulatory compliant core ECG labs that provide Holter and other cardiac services, including continuous ECG with QT analysis
• Pulmonary function and exercise stress testing
• Two FDA audits were conducted in 1995 and 1997; no FDA 483’s were issued
• Designated Sponsor Monitor areas with telephone and internet access
• Fully equipped emergency crash-carts

Contact Information

Dennis A. Ruff, M.D., P.A.
Vice President & Medical Director
ICON Development Solutions
8307 Gault Lane
San Antonio, TX 78209
USA
Phone: 210-614-0062
Fax: 210-616-0278
EMail: IDSinfo@iconplc.com
Web Site: http://www.IDSstudy.com

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.