Center Overview

Type of Center

Providence Clinical Research (PCR) is an independent clinical research site in the Los Angeles area with extensive experience in all phases of clinical research. The center is located in a professional building 0.5 mile from the largest medical center in the San Fernando Valley with over 400 beds, and in close proximity to three other major hospitals in Los Angeles County. Our facility is comprised of:

• 3000 square foot outpatient research facility
• 30 bed inpatient early development/Phase 1 research center.
• 1000 square foot sleep center/extended outpatient stay (ie: 24 hour PK) facility
• Multi-specialty outpatient medical office
• Full service R&D laboratory (GLP and GCP) as well as a CAP/CLIA approved clinical laboratory

Providence Clinical Research (PCR) is both an independent clinical research site with extensive experience as well as a consortium of investigators practicing in the San Fernando Valley region of Los Angeles County. Our organization conducts trials with four in-house investigators. We also provides staff, regulatory services and infrastructure to support a network of community-based investigators. We work with board-certified physicians to train, equip and enable them to conduct clinical research (Phase I - IV) trials in a range of specialty areas.

Providence Clinical Research is located in Burbank, California, less than 5 miles from the Bob Hope Airport (Burbank/Pasadena/Glendale) and 25 miles from Los Angeles International Airport.

Our Core Capabilities

• Highly experienced, dedicated and ACRP/APPI certified staff
• Ability to use central IRB and laboratories
• Dynamic, rapidly growing medical community
• Dedicated patient recruitment specialist
• Dense, ethnically diverse population
• Advanced R&D biomarker laboratory and full service clinical laboratory
• Easily accessible, close parking, beautiful location
• Independent site & Investigator support organization
• Rapid administrative approval - IRB, budgets, contracts
• Experienced with EDC, eCRF, IVRS, FACTS, data fax, portals, and data upload for central reading
• Individualized investigator support services
• Training, certification and continuing education programs
• Underserved populations outreach

Providence Clinical Research (PCR) exists to meet the needs of sponsors, community-based investigators and study subjects to optimize the safe, efficient and timely conduct of high quality clinical research in the community setting. In the spirit of the FDA Critical Path Initiative and the NIH Roadmap: Reengineering the Clinical Research Enterprise (http://nihroadmap.nih.gov), Providence Clinical Research provides critical standards-based and performance-based services:

• early phase clinical development
• late phase clinical development
• full service sleep facility
• full service research diagnostic laboratory for assay and biomarker development
• full service CAP and CLIA accredited clinical laboratory
• investigator support services (i.e., certified CRCs, study procurement, contracts and budget negotiation and administration, IRB submissions, regulatory updates, adverse event reporting assistance, study document management and clinical trial management tools)
• training, certification and continuing education programs

The staff at Providence Clinical Research bring extensive, cross-cutting clinical research experience as well as in-depth knowledge of the needs of sponsors, CRAs and investigators. All are dedicated to uncompromised quality, streamlined performance and the highest standards of research. PCR believes that the following criteria are central to the performance of high quality clinical research:

• Patient safety (good communication and reporting procedures)
• Attention to detail
• Clean, quality data on a timely basis
• Internal quality compliance program
• Excellent customer service
• Sensitive to investigator/subject/sponsor needs (good communication)
• Flexible to change
• Trained support staff with career paths and low turnover rate
• Staffing based upon workload
• Clear assignment of responsibility and accountability
• Optimized workflow and incorporation of technology
• Able to plan ahead and implement
• Well defined capabilities and focus
• Each study given high priority with accessible, central contact person
• GCP and human subjects protection training, education and certification for staff and investigators

Clinical Research Experience

Staff Expertise

The Principal Investigator has 25 years of experience and the remaining staff possess a cumulative 50 years of experience in all aspects of clinical research. This extensive cross-cutting experience spans all aspects of clinical research from preclinical through Phases I-IV, pharmacoeconomic, behavioral, DNA/RNA/tissue collection, pharmacodynamic, pharmacogenomic and proteomic. This has included pharmaceuticals, biologics, devices, nutraceuticals and serologicals in both therapeutic and diagnostic indications. Our staff possess an in-depth understanding of the clinical research process, gleaned from backgrounds that include biopharmaceutical and device industry, behavioral research, IRBs, CROs, SMOs, clinical informatics development, investigational pharmacy, in both public and private settings including NIH, academic and community-based. Through the thoughtful application of our experience to the conduct of each trial, the PCR staff is able to provide excellence, quality and performance to our clients.

PCR strongly encourages and supports certification of all study coordinators, investigators and the investigative site. All study coordinators are certified in CPR and have achieved or are progressing toward C.R.C. certification. Staff capabilities include the following: interview and patient reported outcomes training, scoring and assessments (FF scoring, FACT and quality of life questionnaires, diary assessments), spirometry, PFTs, inhalation therapy, PK sampling, electrocardiograms, blood pressure monitoring (certification for Holter and ambulatory monitoring), pain assessments and evaluations, joint assessments, X-rays, IV infusion, throat cultures, buccal scrapings, gram stains, skin debridement (pressure ulcer treatment), wound dressings, dietary counseling, patient education, laboratory draws and preparation, HAZMAT/IATA training, and shipping and handling of dangerous goods and all types of laboratory specimens including pharmacogenomic/proteomic.

Our diagnostic/reference laboratory operates a full service R&D (GLP & GCP) laboratory as well as a CLIA and CAP approved laboratory, since 1994. We have 118 FTEs to offer comprehensive menu in the following areas: Molecular biology, Chemistry, Hematology, Immunology, Serology, Immunohematology, Special Chemistry, Urine Chemistry, Microbiology, Toxicology, PCR testing, and Cytology. We also have initiatives in standardizing multiplexed analysis of proteins across a variety of platforms that include both Fluorescence and Bead based technologies. We offer multiplexed testing in areas as diverse as COPD, Rheumatoid arthritis, Metabolic Syndrome, Inflammation, Oncology, Allergy, and Asthma.

Therapeutic Areas

Areas of Experience:

A sampling of the Sponsors with whom the staff have worked are listed below:

A sampling of the CROs with whom we continue to work is listed below:

• Covance
• Kendle
• MDS Pharma
• Medpace
• Paragon Biomedical
• Parexel
• PharmaResearch
• PPD-Development
• PPD-Pharmaco
• PRA International
• Robarts
• Sciman Biomedical Research
• Quintiles

A sampling of the Central IRBs with whom the staff have worked is listed below:

• Biomedical Research
• Chesapeake Research
• Coast
• Essex
• IRB
• Inc.
• NEIRB
• Quorum Review
• Schulman Associates
• Western IRB

A sampling of the Central Laboratories with whom the staff have worked is listed below:

• Covance
• ICON
• Mayo Clinical Labs
• Quintiles
• Quest/Unilab

Facility Description

Outpatient

• Comfortable reception area equipped with TV, CD player and VCR
• Patient education stations for private viewing of informed consent form.
• Five fully equipped exam rooms with analog connections for data upload
• Crash cart, supplemental oxygen, suction, and emergency medications
• Five coordinator workspaces with broadband internet, desktop and handheld PCs
• Large, private room and three additional workspaces for monitoring, equipped with:
  • phone
  • broadband internet access
  • high speed facsimile machine on a dedicated line
  • access to photocopier
• Recruiting and community outreach office
• Within walking distance of hospital and all subspecialties
• State-of-the-art pharmacogenomics/proteomics-capable lab processing center in office with:
  • locked -20°, -70° freezers
  • locked refrigerator
  • ambient and refrigerated centrifuges
  • central lab packing and shipping area
• Full service CLIA and CAP approved clinical laboratories
• Full service research laboratory for assay development
• Investigational pharmacy in office
  • 24 hour temperature monitored and alarmed investigational product storage
  • Double locked room temperature storage
  • Double locked -20°, -70° freezers
  • Double locked refrigerated storage
  • Complete investigational pharmacy SOPs and internal pharmacy monitoring
• Locked storage for study supplies
• Segregated casebook (CRF) libraries
• Complete chain of custody for critical study supplies/agent and documents.
• Equipment calibration and maintenance program, critical equipment alarm and backup
• eClinical capabilities and experience:
  • secured local area network with internet access and secure wireless capabilities
  • 21 CFR compliant
  • HIPAA compliant
  • eSource where appropriate
  • electronic data capture (EDC)
  • paperless case report form (eCRF)
  • the remote data entry (RDE)
  • electronic patient diaries and patient reported outcomes (PROs)
  • electronic backup (daily) and electronic archival where appropriate
  • computer-based training
• Enterprise clinical trials management system with active clinical research volunteer recruitment database
• Master plans for secured, user-based access InfoPortals: CRA Study Carrel; Patient Portal; Investigator Resource Portal
• 24/7 Live Operator Service
• High-speed facsimile machines on two dedicated lines
• Complete standard operating procedures (SOPs) and training program
• Handicapped accessible
• Adjacent to major Medical Center for out-patient and inpatient procedures and stays
• Daily FedEx, DHL, World and Airborne pick-up, daily dry ice drops

Inpatient Facility Description

• Secured inpatient unit with card entry/exit, video monitoring, on-site security guard
• Comfortable recreation area equipped with full entertainment system, library, games, computers
• Dining area with catering service
• Fully equipped exam / treatment room with broadband and analog connections
• In-patient investigational pharmacy / dispensary
• Monitoring workspace with phone, fax, copier and broadband internet access
• Three private sleep rooms
• Configurable space to house up to 30 subjects for short or extended in-patient stays
• Plans for hospital based Phase I capacity and 100 bed healthy subject Phase I facility
• Full service clinical and research diagnostic laboratory

Investigator Experience

Principal Investigator

Dr. Teresa Sheahan Sligh, MD, CPI has been actively involved in biomedical and clinical research since 1982. She has been certified as a physician investigator through the Academy of Pharmaceutical Physicians and Investigators since 2004. Her professional career began in the pharmaceutical industry as a medicinal biochemist in preclinical development, development of manufacturing and QC methods and clinical development paths. After obtaining a medical degree at Texas A&M College of Medicine she completed two years of postgraduate medical training in Internal Medicine at Presbyterian Hospital of Dallas. She started and operated a high-performing investigative site in the Dallas are before transferring to the LA area with her husbands surgical training. She has been PI on more than 50 clinical trials with an exceptional track record of quality and meeting enrollment objectives. Dr. Sligh has also been closely involved as sub-investigator, monitor/auditor, or coordinator on an additional 22 clinical trials. Dr. Sligh has cross-cutting experience across the clinical research industry, including both biomedical and clinical research across numerous scientific and clinical disciplines in both academic and private industry settings. She has served as a Director of Regulatory Afairs and as a reviewing member of a joint oncology IRB. She has consulted in the areas of eClinical Trials, compliance and ethics, quality assurance, and clinical development paths. Her specific experience in clinical research has included biologicals (IV and oral), pharmaceuticals (IV, oral, topical), radiopharmaceuticals, serologicals, and devices in numerous therapeutic areas. This has spanned all stages of testing from bench development, product characterization, animal toxicity testing, as well as Phases I, II, III, IV, Rx-to-OTC switch, pharmacoeconomic and health outcomes research.

Medical Director

Scott Preston Sligh, MD, RPh has been involved in clinical pharmacology since 1987. He graduated with a degree in Pharmacy from the University of Texas and practiced in hospital, retail and home-IV pharmacy settings for several years. After going on to obtain a medical degree with honors from Texas A&M College of Medicine, he completed five years of postgraduate medical training in General Surgery at Methodist Medical Center in Dallas, and two fellowships in Colorectal Surgery and Anorectal Physiology at USC. He has been actively involved in clinical research as a principal investigator and sub-investigator since 2000. He currently maintains a clinical practice in Colorectal and General Surgery. As Medical Director he is responsible for the oversight of contract negotiation and management, quality and performance.

Director of Clinical Operations

Maria Edit Lopez, MS, PA-C has 10 years of extensive cross-cutting experience across the disciplines of clinical research. After obtaining a bachelors degree from USC in Biology, she started her professional career as a clinical research coordinator for three years in the therapeutic areas of gastroenterology and internal medicine. With further training as a clinical research associate, she became a certified CRA and monitored for UCLA for three years. Subsequently she served for a year as IRB Coordinator at UCLA Friends Research. While returning to USC to complete a Masters in Health Education and the Physician’s Assistant program she worked as Quality Assurance Manager/Monitor at Providence Clinical Research. Upon obtaining certification as Physician’s Assistant, she accepted a position as Director of Clinical Operations and serves also as sub-investigator.

Medical Advisory Board is comprised of five board certified physician investigators with a cumulative clinical experience of 122 years and a cumulative 52 years as clinical investigators. All serve as investigators and sub-investigators for Providence Clinical Research.

The PCR Investigator Network

PCR is building a network of board certified physician investigators in the following therapeutic areas and providing oversight and support to facilitate the success of these investigators:

Staff Expertise

The staff at PCR bring many years of interdisciplinary expertise together to provide well-coordinated support to our investigators and high-quality service to our sponsors.

Our professional, multi-lingual staff capably provides the following services:

• Protocol Procurement & Review
• Resource Planning and Staffing
• Budget & Contracts Negotiation
• Local and Central IRB Approval Processes
• Document Management
• Study Initiation
• Study Subject Recruitment and Retention
• Screening/Enrollment Procedures
• Study Management
• Case Report Form (or eCRF/EDC) Completion
• Correction and Archival Clinical Data Management
• Regulatory Compliance/Quality Assurance
• Coordination of Monitoring Visits
• Study Communications
• Site Close-Out
• Coordination of FDA/Sponsor Audits

PCR works with each sponsor to assemble the right team of principal investigator, sub-investigators, coordinators and support staff to meet the specific needs of the trial.

Staff Roles & Responsibilities

Quality Assurance Director has been an independent QA/QI consultant to biopharmaceutical industry for over 12 years and has served as director of multiple clinical research facilities including Phase 1 inpatient units, sleep centers and outpatient clinical research units. He functions in quality oversight, change management, quality assurance and control.

Business Development functions in marketing and business development, study start-up and customer relations management.

Dedicated Patient Recruitment Specialist is responsible for development of recruitment plans, materials and management of recruitment / retention strategies to meet enrollment objectives.

Regulatory Coordinator functions in standards and regulatory compliance and all IRB correspondence.

Laboratory Director functions in lab oversight, supervision of all research and clinical laboratory personnel.

Investigational Pharmacy Manager functions in inventory control, dispensing, IVs and compounding where necessary

Clinical Research Coordinators 40% ACRP certified CRCs, 60% in process of obtaining certification.

Nurse Registry RNs and LVNs available on a prn basis for staffing of early development units under supervision of ACRP-certified Research Nurse Coordinator.

Sleeo Technicians full service research sleep equipment and technicians, 'certified' by Dr. Roth's central PSG reading lab in Detroit, MI

Education and Outreach Director patient education and underserved populations outreach

Registered Dietician available on a contingency basis

Patient Demographics

Providence Clinical Research offices are conveniently located in the Los Angeles County area (population of 3 million), bordering the Riverside-San Bernardino Counties (combined population of 3.1 million), the Ventura County (population of 750,000), and the Orange County area (population of 2.5 million). Each of these four counties is demographically distinct, ranging from 20% to 65% nonwhite in race. PCR is working with community advocacy groups to build outreach programs into underrepresented communities to encourage their participation and important representation in the advancement of medical knowledge.

The patient population in the Los Angeles County area is unique in its density and diversity. The population is highly dense, aiding in subject recruitment and the targeting of highly refined segments of the population. The population spans both race/ethnicity and socioeconomic strata, allowing for independent analysis of these confounders.

Patient recruitment is through the electronic database maintained by PCR, investigator private practice patients, non-investigator physician referrals, liaisons with community and outreach services, and through radio and television advertising when appropriate.

The staff at PCR have extensive experience with effective patient recruitment / retention strategies and are knowledgeable about how to implement Ad/Referral programs.

Other Information

Rapid administrative approval - IRB, Budgets, Contracts.

Providence Clinical Research is located in a key location in the San Fernando Valley in Southern California. Our office location provides very easy access to major freeways.

Tremendous growth is occurring in the medical community in our neighborhood with the openings of a recent hospital expansion and several new professional building recently. A new cancer center and an additional professional building are under construction.

Our investigative site is highly SOP and metrics centered.

Contact Information

Teresa S. Sligh, M.D.
Principal Investigator
Providence Clinical Research
A Division of Translational Research Group, Inc.
3808 Riverside Drive, Suite 400
Burbank, CA 91505
USA
Phone: 818-558-7555
Fax: 818-558-4099
EMail: tsligh@providenceclinical.com
Web Site: http://www.providenceclinical.com

Currently Enrolling Trials

• A research study evaluating an investigational medication in the treatment of Irritable Bowel Syndrome (also known as IBS).
• Bothered by Arthritis? Concerned about heart disease?
• Do you have Asthma?
• Has IBS distorted your way of life?
• Help us study inhaled insulin. You could bring a breath of fresh air to diabetes research.
• High Blood Pressure....Not Knowing Your Risks Can Hurt You
• HIV positive? Interested in an investigational vaccine for immune suppressed people, like those with HIV, to potentially protect against smallpox?
• Is Diabetes a Part of Your Life?
• Psoriasis Research Study
• Severe Pain during your Bowel Movements?
• Smallpox is an old enemy. Research may help it from becoming a new one.
• Type 2 Diabetes: Giving Medication a Try

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.