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
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:
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
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:
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:
Areas of Experience:
We have worked with the following Sponsors:
A sampling of the CROs with whom we have worked is listed below:
A sampling of the Central IRBs with whom we have worked is listed below:
A sampling of the Central Laboratories with whom the staff have worked is listed below:
Inpatient Facility Description
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.
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.
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:
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. 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.
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.