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

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:

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

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.

Cardiology/Vascular Diseases
Dermatology/Plastic Surgery
Endocrinology
Gastroenterology
Hematology
Immunology/Infectious Diseases
Musculoskeletal
Nephrology/Urology
Neurology
Obstetrics/Gynecology
Oncology
Ophthalmology
Otolaryngology
Pediatrics/Neonatology
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology