LGBT Cancer Project

Providence Clinical Research

Center Information

Teresa S. Sligh, M.D.
Principal Investigator
Providence Clinical Research
Translational Research Group, Inc., dba Providence Clinical Research
6400 Laurel Canyon Boulevard, Suite 300A
North Hollywood, CA 91606
USA
818-558-7555
818-558-4099 (fax)
tsligh@providenceclinical.com
www.providenceclinical.com
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Currently Enrolling Trials

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Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Devices
Endocrinology
Family Medicine
Gastroenterology
Genetic Disease
Healthy Volunteers
Hematology
Hepatology (Liver, Pancreatic, Gall Bladder)
Infections and Infectious Diseases
Internal Medicine
Musculoskeletal
Neurology
Obstetrics/Gynecology (Women’s Health)
Oncology
Ophthalmology
Otolaryngology (Ear, Nose, Throat)
Pharmacology/Toxicology
Pulmonary/Respiratory Diseases
Rheumatology
Urology

Center Overview

Type of Center

Providence Clinical Research (PCR) is a multi-specialty private practice and independent clinical research site in the San Fernando Valley region of Los Angeles County with extensive experience in all phases of clinical research. The center is located 4 miles 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 consists of:

  • 5000 square foot outpatient research facility
  • 5 bed, 1000 square foot inpatient early development / Phase 1 / extended outpatient stay (ie: 24 hour PK) facility
  • Multi-specialty outpatient medical office
  • Layout designed for the conduct of clinical research

Providence Clinical Research (PCR) conducts trials with three full-time in-house investigators, four coordinators and eight full-time support staff including dedicated regulatory, lab, recruitment and quality assurance staff. We work with a consortium of specialists from our local medical community.

The investigators and staff have conducted over 400 clinical trials with a track record of performance and quality. Three FDA inspections have resulted in no observations. One FDA inspection resulted in no site observations but did result in one sponsor/CRO observation. One inspection resulted in an observation that had been previously self-reported by the investigator and the FDA deemed that no further action was indicated. Dozens of sponsor audits as a high enroller have resulted in no significant observations.

The facility is located in North Hollywood, California, only 2 miles from the Bob Hope Airport - BUR (Burbank/Pasadena/Glendale) and 25 miles from Los Angeles International Airport - LAX. This location is easily accessible from two major highways and parking is readily available in our adjacent parking garage.

The site is immersed in a vacation destination with beaches, water sports, whale watching, mountains, snow sports, major motion picture studios, recording industry, Hollywood and many other sightseeing opportunities. Not least of all, Los Angeles offers consistently beautiful weather.

Our Core Capabilities

  • Highly experienced ACRP/APPI certified staff
  • Ability to use central IRB and central laboratories
  • Rapid administrative approval - IRB, budgets, contracts
  • Dynamic, rapidly growing medical community with a network of sub-specialists for specialty assessments and procedures (nerve conduction velocities, colonoscopy, endoscopy, ENT evaluations, audiology, dilated eye exams, gynecologic procedures, etc.
  • Dedicated patient recruitment team with a research participant database
  • Densely populated, ethnically diverse patient population
  • Have successfully enrolled and completed ethnic/gender specific studies for Japanese bridging studies, African American studies, Womens’ studies.
  • Have two local full service clinical laboratories
  • Work routinely with four local radiology facilities offering extensive capabilities: plain film, MRI, CT, Ultrasound, DEXA, and specialized imaging such as the Dixon procedure among others. Routinely upload images for central over reads (Bioclinica, etc.)
  • Experienced with EDC, eCRF, IVRS/IWRS, FACTS, data fax, portals, and data upload for central ECG reading
  • Staff has expertise in joint injection, joint counts, pulmonary function testing, NIOX FeNO, skin biopsies (flash freezing, embedding into OCT or paraffin blocks), skin strips, buccal scraping, ABPM, holter, telemetry, CGM, OGTT, device implantation, infusions, tilt testing, ACTH stimulation testing, cell pelleting/washing, sample processing, and much more.
  • In-house secure pharmacy with laminar flow hood for compounding and sterile prep of IA/IV/IM injectables, narcotics cabinets, min-max temperature monitored refrigerated and ambient storage.
  • Metrics-based performance via proprietary processes and CTMS
  • Quality Assurance Compliance Program

Mission Statement

The mission of Providence Clinical Research (PCR) is to optimize the 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 niche translational and clinical research services:

  • early phase clinical development in indication in the community setting
  • late phase clinical development in the community setting
  • collection of clinically-enriched biological specimens for preclinical and translational research
  • engagement of community based private practice physicians in the clinical research process and mentoring of physicians interested in becoming investigators.
  • in-house training and certification prep programs

Clinical Research Experience

Staff Expertise

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.

The three core investigators have a total of 63 years of research experience and the remaining staff possess a cumulative 45 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, and global government and academic research. This has included pharmaceuticals, biologics, biomedical devices, nutraceuticals and serologicals in both therapeutic and diagnostic indications. Our staff bring an in-depth understanding of the clinical research process, gleaned from backgrounds that include biopharmaceutical and device industry, biostatistics, IRBs, SMOs, clinical informatics development, investigational pharmacy, in public and private settings including NIH, global government, large corporate, academic and small business. 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 CRC certification. Staff capabilities include the following:

  • PROs
  • experience with numerous questionnaires
  • experience with numerous e-diaries and site tablets
  • spirometry, PFTs, inhalation therapy,
  • PK sampling,
  • electrocardiograms,
  • blood pressure monitoring (certification for Holter and ambulatory monitoring),
  • diet and exercise counseling
  • laboratory draws and preparation, HAZMAT/IATA training, and shipping and handling of dangerous goods

Therapeutic Areas

Areas of Experience:

  • Gout
  • Hot Flash
  • Chronic Heart Failure
  • Hypertension
  • Hyperlipidemia
  • COPD
  • Asthma
  • Healthy
  • Hypogonadism
  • Acute Sinusitis
  • Bronchitis (Acute & Chronic)
  • Community Acquired Pneumonia
  • Smoking Cessation
  • Urinary Tract Infection
  • Type 1 Diabetes
  • Type 2 Diabetes
  • Osteoarthritis
  • Allergy and Allergic Rhinitis
  • Fibromyalgia
  • Rheumatoid Arthritis
  • Back Pain
  • Gastroesophageal Reflux Disease
  • Irritable Bowel Syndrome
  • Crohn's Disease
  • Ulcerative Colitis
  • Dermatology - Acne, Rosacea, Actinic Keratoses
  • Chronic Pain
  • Opioid Induced Constipation
  • Diabetic retinopathy/neuropathy/nephropathy
  • Gene therapy
  • Pharmacokinetics/pharmacodynamics
  • Phsoriasis
  • Constipation
  • Colon Cancer
  • Herpes Labialis
  • Genital Herpes
  • Vaccine studies - including DOD
  • Influenza - treatment and vaccine
  • HIV
  • Hepatitis

We have worked with the following Sponsors:

  • Abbott/AbbVie
  • Access Business Group
  • Acrux
  • Akros
  • Alizyme
  • Allergan
  • Amarin
  • Amgen
  • Amylin
  • Anacor
  • Anika
  • Antares
  • Ardelyx
  • Astra-Zeneca
  • Auxilium
  • Axsome
  • Beckman Coulter
  • Biocryst
  • Biodel
  • BioMarin
  • Boerhinger Ingelheim
  • Bristol-Myers Squibb
  • Endo
  • Epeius Biotechnologies
  • Centocor
  • Cephalon
  • Clarus
  • Concert
  • CTEP
  • Cubist
  • DOV
  • Daichi Sankyo
  • Dr. Reddy
  • Eisai
  • Elcelyx
  • Eli Lilly
  • Ethicon
  • Ferring
  • Flexion
  • Focus Diagnostics
  • Forest
  • Furiex
  • Genetics Collaborative
  • Genentech
  • GlaxoSmithKline
  • Great Lakes
  • Hanmi
  • Heel
  • Hemacare
  • Hisamitsu
  • Hollis Eden
  • Immune Response Corp.
  • Immunodiagnostics Systems
  • Intarcia
  • Ironwood
  • Janssen
  • Jazz Pharmaceuticals
  • Johnson & Johnson
  • Kaketsuken
  • Kowa
  • Ligand
  • Lipocine
  • Logical
  • Medeva
  • Medimmune
  • Medivector
  • Menarini
  • Merck
  • Merz
  • Metabolex
  • MT Group
  • Mylan
  • NanoBio
  • Novartis
  • NovoNordisk
  • Novum
  • Opti-Nose
  • Oramed
  • Orexo
  • Otsuka
  • Pearl
  • Perrigo
  • Pfizer
  • PhereSys
  • Pharmacia
  • Pharmasset
  • Pharmos
  • Pozen
  • Procter and Gamble
  • Promius
  • Proteus
  • Purdue
  • Quinnova
  • RedHill
  • Regeneron
  • Replidyne
  • Renovo
  • Response Biomedical
  • Roche
  • Salix
  • Sanofi-Aventis
  • Sandoz
  • Seracare
  • Schering Plough
  • Searle
  • Seikagaku
  • Sepracor
  • Seracare
  • Serono
  • Shionogi
  • Shire
  • Skypharma
  • Solvay
  • Speedel
  • Sucampo
  • Surface Logix
  • Synergy
  • Takeda
  • Teva
  • Therapeutics Inc.
  • Tibotec
  • Tioga
  • Tobira
  • Trimel
  • Ventrus
  • Vermillion
  • Vertex
  • Viking
  • Vivus
  • Wyeth-Ayerst
  • Zogenix

A sampling of the CROs with whom we have worked is listed below:

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

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

  • Aspire
  • Biomedical Research
  • Chesapeake Research
  • Coast
  • Copernicus Group
  • Compass
  • Essex
  • IRB
  • Inc.
  • IntegReview
  • Goodwyn
  • NEIRB
  • Quorum Review
  • RTI
  • Sterling
  • Schulman Associates
  • Western IRB

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

  • ACM
  • Covance
  • ICON
  • PPD
  • Mayo Clinical Labs
  • Medpace
  • Quintiles
  • Quest/Unilab

Facility Description

Outpatient

  • Comfortable reception area equipped with TV and coral reef tank
  • ADC monitored security system with video cameras, motion sensors
  • Eight fully equipped exam rooms
  • Analog connections for data upload
  • Crash cart, supplemental oxygen, suction, emergency medications and defibrillator
  • Restricted access bullpen-style staff area with individual cubicle workspaces equipped with phone, broadband internet and desktop PCs
  • Large, secure room with monitor four workspaces, equipped with:
    • phone
    • broadband and wireless internet access
    • access to high speed facsimile machine or scanner
    • access to photocopier
    • coral reef tank
  • Recruiting and community outreach team
  • Large storage areas for on-site archiving of study records
  • CLIA/PPMP waived lab processing center in office with:
    • secure -20°, -70° freezers
    • secure refrigerator
    • ambient and refrigerated centrifuges
    • central lab packing and shipping area
  • Full service CLIA and CAP approved clinical laboratories
  • Secure spirometry room
  • Investigational pharmacy in office
    • 24 hour temperature monitored and alarmed investigational product storage
    • Double locked room with motion detection
    • Double locked -20° freezer
    • Double locked refrigerated storage
    • Laminar flow hood for sterile prep of injectables and compounding
  • Locked storage for study supplies
  • Segregated regulatory binder library
  • 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
  • High-speed facsimile machines on two dedicated lines
  • Complete standard operating procedures (SOPs) and training program
  • Handicapped accessible
  • Daily FedEx, DHL, World and Airborne pick-up, daily dry ice pickup

Inpatient Facility Description

  • Secured inpatient unit with after hours card access to the floor, controlled entry/exit, video monitoring, on-site security guard
  • Dining area with meal/catering services
  • Fully equipped exam / treatment rooms with broadband and analog connections
  • In-patient investigational pharmacy / dispensary
  • Monitoring workspace with phone, fax, copier and broadband internet access
  • Five private in-patient rooms
  • Configurable space to house up to 5 subjects for short or extended in-patient stays
  • Full service local clinical and research diagnostic laboratory
  • Full service local imaging capabilities

Investigator Experience

Medical Director

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, product characterization, animal toxicity testing, development of manufacturing and QC methods and clinical development paths. She served as a monitor, auditor and in the preparation of an NDA submission. After obtaining a medical degree at Texas A&M College of Medicine she trained in Internal Medicine at Presbyterian Hospital of Dallas where she mentored with and served as sub-investigator to a prominent clinical investigator. She worked as a principal investigator with a high-performing investigative site in the Dallas area before transferring to the LA area. Dr. Sligh has cross-cutting experience across the clinical research industry. She has served as a Director of Regulatory Affairs/Quality Assurance for a biopharmaceutical company and as a reviewing member of the Georgetown /Washington University oncology IRB. She has consulted in the areas of eClinical Trials, compliance and ethics, quality assurance, and clinical development paths. She has been PI on hundreds of clinical trials over the past 18 years with a demonstrated track record of quality and meeting enrollment objectives. Her current emphasis is to standardize and optimize the conduct of clinical research in the community setting and enable the provision of healthcare to underserved populations via clinical research.

Medical Director

Scott Preston Sligh, MD, RPh has been involved in clinical pharmacology and clinical research 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 the University of Southern California. He was in practice as a general and colorectal surgeon at the University of Southern California and an attending physician at Providence St. Joseph Medical Center. He has been actively involved in clinical research as a principal investigator and sub-investigator since 2000. He developed the site's capabilities in investigational pharmacy to include investigational compounding and sterile prep of infusions and injectables. As Medical Director and CEO he is responsible for the oversight of contract negotiation and administration, site financial management, site quality and performance. He is currently focused on increasing efficiencies in the operation of clinical research investigative sites.

Medical Director

George Levon Melikian, MD, MPH has been involved in biomedical and clinical research since 1996. He obtained a MPH in Public Health and Biostatistics from Yale where he was awarded the Wilbur G Downs International Health Fellowship and the Curtis D. Heaney Memorial Fellowship: HIV/AIDS. He went on to serve as faculty statistician at Johns Hopkins where he was awarded the Nestle John M. Kinney International award for his paper on Pediatric Nutrition. While obtaining his medical degree at New York Medical College he was awarded the Rosenbluth Foundation International Medicine Fellow. His Internal Medicine Residency was completed at the University of Rochester and he completed both clinical and research fellowships at Stanford University in Infectious Diseases. He subsequently served for 2 1/2 years as Medical Director and Director of Research for the AIDS Healthcare Foundation. He joined Providence Clinical Research as Medical Director and Clinical Investigator and currently supervises the conduct of clinical trials. Dr.Melikian brings his expertise as an experienced clinical physician, a clinical investigator, and as a professional statistician with proficiency in advanced machine learning methods. He is responsible for developing and implementing quantitative methods to measure and refine the structure and implementation of investigative site informatics, database mining, recruitment strategies, and analysis of operational workflows that are all vital components of clinical research practice management.

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. We strive to enroll a test population that most closely represents the eventual patient population.

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 social media, print, 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 buildings including a new cancer center.

Contact Center

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