Teresa S. Sligh, M.D.
Providence Clinical Research
Translational Research Group, Inc., dba Providence Clinical Research
6400 Laurel Canyon Boulevard, Suite 300A
North Hollywood, CA 91606
Currently Enrolling Trials
- Cardiology/Vascular Diseases
- Family Medicine
- Genetic Disease
- Healthy Volunteers
- Hepatology (Liver, Pancreatic, Gall Bladder)
- Infections and Infectious Diseases
- Internal Medicine
- Obstetrics/Gynecology (Women’s Health)
- Otolaryngology (Ear, Nose, Throat)
- Pulmonary/Respiratory Diseases
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 including an endocrinologist, dermatologist, pulmonologist, ophthalmologists, gastroenterologists, ENT, gynecologist, among others.
The investigators and staff have conducted over 475 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
- 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 of more than 10,000 individuals - searchable for disease state, ethnicity, key lab values.
- Densely populated, ethnically diverse patient population
- Special populations expertise - have successfully enrolled and completed ethnic/gender specific studies for Japanese bridging studies, African American studies, Women's and women’s studies.
- Have two local full service clinical laboratories
- CLIA and PPMP Waived laboratory on site
- Four local radiology facilities plain film, MRI, CT, Ultrasound, DEXA, and specialized imaging such as the Dixon procedure among others.
- Routinely upload images for central radiologist (Bioclinica, etc.)
- Experienced with EDC, eCRF, IVRS/IWRS, FACTS, data fax, portals, and data upload for central ECG reading
- Very experienced with handheld technologies for PROs, questionnaires and clinical assessments on mobile platforms – smart phones, tablets, devices.
- Staff has expertise in joint injection, joint counts, spirometry, DLCO, NIOX FeNO, skin biopsies, tissue processing (flash freezing, embedding into OCT or paraffin blocks), skin strips, buccal scraping, ECG, ABPM, holter, telemetry, CGM, OGTT, device implantation, infusions, tilt testing, ACTH stimulation testing
- Very experienced with PK/PD Biomarker collections
- Class 2 Biohazard hood lab for sterile sample processing, cell pelleting/washing, PBMC isolation, TruCulture, RNA and DNA isolation
- Incubator for quantiFERON, etc. Heat block for sample processing. Cool cell for slow freeze and liquid nitrogen for flash freeze
- HAZMAT/IATA training, and shipping and handling of dangerous goods
- 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.
- Diet and exercise counseling
- Metrics-based performance
- Quality Assurance Compliance Program
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 primary investigators.
- in-house training and certification prep 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.
The core investigators have a total of 54 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:
Areas of Experience:
- Atrial Fibrillation
- Chronic Heart Failure
- Acute Sinusitis
- Bronchitis (Acute & Chronic)
- Community Acquired Pneumonia
- Smoking Cessation
- Urinary Tract Infection
- Type 1 Diabetes
- Type 2 Diabetes
- Allergy and Allergic Rhinitis
- Rheumatoid Arthritis
- Back Pain
- Gastroesophageal Reflux Disease
- Irritable Bowel Syndrome
- Crohn's Disease
- Ulcerative Colitis
- Actinic Keratoses
- Atopic Dermatitis
- Chronic Pain
- Opioid Induced Constipation
- Diabetic retinopathy
- Diabetic neuropathy
- Diabetic nephropathy
- Chronic kidney disease
- MACE studies
- Cardiovascular outcomes
- Gene therapy
- Anal Fissure
- Colon Cancer
- Overactive Bladder
- Women’s studies
- Hot flash
- Sexual dysfunction
- Herpes Labialis
- Genital Herpes
- Vaccine studies - including DOD
- Influenza - treatment and vaccine
- Comfortable reception area equipped with TV
- ADC monitored security system with video cameras, motion sensors
- Ten 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:
- broadband and wireless internet access
- access to high speed facsimile machine or scanner
- access to photocopier
- 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
- 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
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.
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.
The professional, multi-lingual staff bring
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.
Nurse Registry RNs and LVNs available on a prn basis for staffing of early development units under supervision of ACRP-certified Research Nurse Coordinator.
Registered Dietician available on a contingency basis
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.
Our patient population is roughly 30% African American, 30% Hispanic Caucasian, 30% Non-hispanic Caucasian, 7% Asian, 2% Pacific Islander/Hawaiian, 1% Native American.
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, health fairs,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.
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 and public transportation..
We have worked with the following Sponsors:
- Access Business Group
- 4D Pharma
- Beckman Coulter
- Boerhinger Ingelheim
- Bristol-Myers Squibb
- Epeius Biotechnologies
- Daichi Sankyo
- Dr. Reddy
- Eli Lilly
- Focus Diagnostics
- Genetics Collaborative
- Great Lakes
- Hollis Eden
- Immune Response Corp.
- Immunodiagnostics Systems
- Jazz Pharmaceuticals
- Johnson & Johnson
- MT Group
- Procter and Gamble
- Response Biomedical
- Schering Plough
- Surface Logix
- Sun Pharma
- Taiwan Liposome
- Therapeutics Inc.
- White Sands
CROs with whom we have worked is listed below:
- MDS Pharma
- Paragon Biomedical
- PRA International
- Premiere Research
- Sciman Biomedical Research
Central IRBs with whom we have worked is listed below:
- Biomedical Research
- Chesapeake Research
- Copernicus Group
- Quorum Review
- Schulman Associates
- Western IRB
A sampling of the Central Laboratories with whom the staff have worked is listed below:
- Mayo Clinical Labs