About CRI Worldwide
CRI Worldwide is a premier research facility with four strategic locations in Philadelphia and New Jersey. Our dedicated team of experienced clinical research professionals provides rapid study start-up, quality patients and clean data for even the most difficult trials. Our ongoing patient recruitment strategies also ensure our sponsors have access to over seven million people living in the immediate Delaware Valley. Through our exclusive partnerships with Lourdes Health System in Burlington County and with The Kirkbride Center in Philadelphia, CRI conducts a full complement of inpatient and outpatient clinical trials (Phases I, II, III, IV). The Kirkbride facility gives sponsors access to 75 licensed beds with the ability to flex up to 75 additional standard beds. This is in addition to the 34 licensed beds at CRI’s Lourdes Inpatient facility. CRI offers state-of-the-art facilities and clinical trial services geared specifically for the rigorous demands of clinical research trials.
CRI provides a broad range of services to meet the specific requirements of clinical development programs according to the standards of Good Clinical Practice (GCP) and ICH guidelines. Many of our studies have been published and recognized worldwide. CRI's Phase I through Phase IV clinical trial experience focuses on Pediatrics, Adolescents & Adults in the following areas:
- Acute & Chronic Pain
- Attention Deficit Hyperactive Disorder
- Alzheimer’s Disease
- Atypical Depression
- Back Pain
- Bipolar Disorder
- Cancer Pain
- Diabetes
- Epilepsy
- Fibromyalgia
- General Anxiety Disorder
- Hepatitis
- Major Depressive Disorder
- Manic Depression
- Migraine/Headaches
- Mild Cognitive Impairment
- Multiple Sclerosis
- Neuropathic Pain
- Obesity
- Obsessive Compulsive Disorder
- Panic Disorder
- Parkinson’s Disease
- Premenstrual Dysphonic Disorder
- Relapse Depression
- Schizoaffective Disorder
- Schizophrenia
- Sexual Dysfunction
- Sleep Disorders
- Social Anxiety Disorder
- Vascular Dementia
- Women’s Health
CRI’s Capabilities
CRI has the ability to conduct research in most clinical trial designs. Our capabilities include:
- ADME
- Bioequivalence / Bioavailability
- Cardiac Safety & QTc
- Dose Ranging & Maximum Tolerability
- Drug Interaction & Drug Metabolism
- Food Interaction
- EEG / ECG
- Mechanism of Action
- MRI
- PET Scanning
- Pharmacokinetics (PK)
- Pharmacodynamics (PD)
- Radio-labeling
- Safety & Efficacy Testing
- Smoking Control
- Structure-activity Relationships
- Surrogate Marker
Phase I & Early Stage Clinical Capabilities
A leader in Phase One and Early Stage clinical research, CRI Worldwide conducts trials in early stage development. Our inpatient facility, located inside Lourdes Medical Center of Burlington County (Rancocas Division), allows broad coverage across most clinical specialties associated with Phase I research. Recent Experience includes: Bioequivalence / Bioavailability, Pharmacokinetics, MAD / SAD, Safety and Efficacy, Cardiac Safety and QTc, Drug Interaction Structure-activity Relationships, Surrogate Marker Mechanism of action, Dose Ranging and Maximum Tolerability, Drug Metabolism.
Pain Research
CRI's Center for the Research of Pain Disorders conducts Phase I through Phase IV inpatient and outpatient clinical trial services for acute and chronic pain, with specific expertise in bioequivalence, bioavailability, PK/PD studies, cardiac safety (QTc), and proof of concept work. The Center's staff has conducted more than 100 clinical trials, including extensive experience in neuropathic pain, post herpetic neuralgia, back pain and fibromyalgia.
The Cognition Center
In an effort to accurately and efficiently simulate a proper testing environment, CRIWW has created a dedicated Cognition Center. This 3,000 square foot facility is equipped with state- of-the-art equipment and is staffed by expert PhD’s and Psychometricians. Working with sponsors, The Cognition Center can be used to conduct any and all paper/pencil cognition assessment tools – as well as virtually all work station based computer aided designs.
Rapid Patient Recruitment
CRI is able to overcome recruitment challenges by identifying quality patients and volunteers through our unique patient recruitment efforts. Located just 10 miles from Philadelphia, our corporate office houses a state-of-the-art Patient Recruitment Center featuring an in-house call center, community outreach team, transportation services, physician referral networks, and an extensive patient database which includes over 40,000 disease-state and healthy volunteers. CRI also maintians a paitent portal, www.CriTrials.com. Utilizing the internet as a means to communicate with potential subjects is just one of our succeful patient recruitment techniques.
The Sleep Center
The CRI Sleep Center, located at the Lourdes Medical Center of Burlington County, is led by Dr. Scott Sharetts, MD, a Board Certified Neurologist. CRI's Sleep Center research initiatives include sleep disorders such as sleep apnea, insomnia and narcolepsy. At the Sleep Center, neurologists and pulmonologists work together with registered electroencephalographic and polysomnographic technologists to conduct painless diagnostic tests with sophisticated high-tech equipment.
CRI Worldwide’s Leading Physicians
Quality care leads to quality results. Our knowledgeable, experienced medical staff makes the difference when it comes to thoughtful care, a critical eye to results, and good medicine. Get to know some of the people that make CRI the caring leader in clinical research.
Dr. Howard Hassman, Chief Scientific Officer, Principal Investigator
Dr. Howard Hassman has over 25 years of experience in clinical research. He teamed with the most respected organizations conducting studies that led to medical and technological breakthroughs. Dr. Hassman began conducting clinical trials in 1982 and is considered an expert in the field of Psychopharmacology. He is Board Certified in Family Practice as an Osteopathic Physician and Surgeon in California, Pennsylvania and New Jersey.
Dr. Hassman received his medical degree from the Philadelphia College of Osteopathic Medicine in 1983. He conducted his rotating internship at the John F. Kennedy Memorial Hospital University of Medicine and Dentistry and trained as an investigator with W. George Case, MD, Director of Training in the Conduct of Clinical Research at the University of Pennsylvania. He also trained for 13 years as an investigator with Karl Rickles, MD, Chairman of the Department of Psychiatry at the University of Pennsylvania. Dr. Hassman worked as an Associate Professor in the Department of Psychiatry at the University of Pennsylvania from 1984 to 1993. While teaching, he also worked for The Prudential Insurance Company of America as a Medical Director for PruCare Plus of San Diego. From 1984 through 1997, Dr. Hassman worked as a General Practitioner at the Family Practice Associates of San Diego, Inc. Dr. Hassman also worked together with Dr. Karl Rickels at his research facility, CMCR, where he was the Medical Director during this time.
In 1998, he established CNS Research Institute (now CRI Worldwide) and currently serves as its Chief Scientific Officer. Dr. Hassman is an expert in CNS research. Currently, he is on the Advisory Board at Eli Lilly & Co. for Atomoxetine in ADD and ADHD for Pediatrics, Adolescents and Adults. He is also a member of the Scientific Advisory Group at Organon, Inc. for The New Treatment Option for the Mature Depressed Patient, and serves on the Advisory Panel for Adult ADHD at Novartis.
Dr. Hassman’s many publications include his book Alternative Treatments for Common Conditions, Copyright © 2000 by Quality Medical Publishing, Inc.; the posters “Mirtazapine vs. Sertraline after SSRI Non-Response” and “Mirtazapine vs. Paroxetine in Elderly Depressed Patients”; articles such as “Antidepressants for the Treatment of Generalized Anxiety Disorder: A Placebo Controlled Comparison of Imipramine, Trazodone and Diazepam”, “Buspirone and Imipramine for Treatment of Major Depression in the Elderly”, “Adinazolam, Diazepam, Imipramine and Placebo in Major Depressive Disorder, A Controlled Study” and “Comparative Study of the Clinical Effectiveness of a Pyrethrin-Based Pediculicide with Combing Versus a Permethrin-Based Pediculide with Combing”; and the clinical abstract “Long-term Efficacy and Safety of Rosuvastatin: Results of a 52-week Comparator-Controlled Trial Versus Pravastatin and Simvastatin” and “Multi-site, Open Label, Observational Study of the Effectiveness and Safety of Remeron SolTab (Mirtazapine Orally Disintegrating Tablets in Depressed Patients Who Are at Least 50 Years of Age)”. Dr. Hassman has lectured extensively on these and related topics.
Dr. Steven J. Glass, MD, Psychiatric Medical Director, Principal Investigator
Dr. Steven Glass is highly qualified in the fields of psychiatry and mental health. He joined CNS Research Institute (now CRI Worldwide) as the Psychiatric Medical Director. He received an MD from Thomas Jefferson Medical College and a Bachelors of Arts in Biology from Swarthmore College. He completed a psychiatric residency at Thomas Jefferson University Hospital, where he served as the Chief Resident in Psychiatry. He is licensed to practice in New Jersey and Pennsylvania. He has extensive experience in CNS clinical research.
Dr. Glass also has extensive experience in the healthcare industry and academia. He worked as the Medical Director for Inpatient Services at Mercy Fitzgerald Hospital, as President of Rainbow Healthcare Associates, as Medical Staff Director of the Mental Health Unit at Rancocas Hospital, as Chairman of the Department of Psychiatry at Bridgeton Division of the South Jersey Hospital System and as Medical Director of the Mental Health Unit at Underwood Memorial Hospital. Academically, he has held positions as Clinical Assistant Professor of Psychiatry at Robert Wood Johnson School of Medicine of Rutgers University, as Adjunct Clinical Assistant Professor of Psychiatry and Human Behavior at Thomas Jefferson University, as Clinical Assistant Professor of Psychiatry at Temple University School of Medicine and as Education Programs Faculty for the Joint Commission on Accreditation of Healthcare Organizations.
David G. Krefetz, DO, MBA, FAPA, FACN, Director of the Pediatric Center for Excellence, Principal Investigator
Dr. David Krefetz is Board Certified in Psychiatry and in Child Adolescent Psychiatry by both the American Board of Psychiatry and Neurology, as well as by the American Osteopathic Board of Neurology and Psychiatry. He also has certification in Administrative Psychiatry by the American Psychiatric Association. Dr. Krefetz is currently the Director of the Pediatric Center for Excellence and has been a Principal Investigator at CRI Worldwide since 2004.
He received his medical degree in 1985 from Des Moines University College of Osteopathic Medicine and Surgery in Iowa. He completed his undergraduate education at the University of Pennsylvania in Philadelphia, and graduated in 2002 from the Temple University-Fox School of Business Executive MBA program in Philadelphia. Dr. Krefetz completed his internship at Memorial Hospital in York, PA, and completed his Psychiatry Residency, Child and Adolescent Psychiatry Fellowship at the Medical College of Pennsylvania/Eastern Pennsylvania Psychiatric Institute in Philadelphia.
Previously, Dr. Krefetz was the Director of Education in Psychiatry at the University of Medicine and Dentistry of New Jersey School of Osteopathic Medicine. Dr. Krefetz remains on the voluntary faculty at UMDNJ. Dr. Krefetz has clinical experience working in a variety of settings including inpatient, outpatient, community and schools. He has a special clinical interest in disruptive behavior, mood, and anxiety disorders in youth, as well as with patients of all ages with HIV illness. He has been the author of research studies on the evaluation of mood disorders in youth, as well as on the evaluation of depression and pain in persons with HIV illness.
Dr. Krefetz has been a frequent presenter at both national and regional professional meetings including at the annual meetings of the American Psychiatric Association and of the American Academy of Child and Adolescent Psychiatry. He also served as Program Director of the Atlantic Regional Osteopathic Convention in 1996. Dr. Krefetz lectures frequently to the community and is a Distinguished Fellow of the American Psychiatric Association and a Fellow of the American College of Neuropsychiatrists. He is a member of the Sigma Sigma Phi National Osteopathic Honor Fraternity and the Beta Gamma Sigma National Business Honor Society and has been a recipient of the Teaching Service Incentive Award at UMDNJ.
Daniel Gruener, MD, Director of the Center for the Research of Pain Disorders, Principal Investigator
Dr. Daniel Gruener completed his psychiatric training at Jefferson Medical College in Philadelphia in 1991 and served as Chief Resident in Psychiatry during his last year of residency. He has received additional training in pain medicine, is certified in psychiatry and pain medicine and has been on the volunteer teaching faculty of Jefferson Medical College since 1992. Dr. Gruener currently serves as Director of the Center for Pain Research and Principal Investigator at CRI.
Active both academically and clinically, Dr. Gruener has divided his time between the fields of psychiatry and pain medicine. He is active in clinical and administrative work in psychiatry, and served as President of the Medical Staff of Friends Hospital in Philadelphia for two years and as Medical Director of Inpatient Services for several years. Dr. Gruener was also a member of the board of managers at Friends Hospital for four years where he founded the Friends Hospital Chronic Pain Management Program and served as its medical director.
In addition to his administrative posts, Dr. Gruener is involved in clinical research, teaching, clinical practice, and writing in the fields of pain management and psychiatry. He has chaired numerous conferences, continuing medical education programs, advisory boards, and similar activities both nationally and internationally, and is a frequent invited lecturer. Active in many causes related to pain medicine, he is the immediate past-president of the Greater Philadelphia Pain Society, the Mid-Atlantic branch of the American Pain Society. In addition, Dr. Gruener recently coauthored the textbook Cognitive Therapy with Chronic Pain Patients with Dr. Aaron Beck of the University of Pennsylvania.
Also active in clinical practice, he continues serving a patient population. He was named one of the “Top Docs” by Philadelphia Magazine in 2002. His recent projects include serving as senior editor on a guide to treating pain in the primary care setting, Pain Control in the Primary Care Setting, which was published by the American Pain Society. Dr. Gruener also recently completed a guide to treating acute pain for Medscape, an Internet-based medical journal, and reviewed a guide book on pain pharmacology which is currently in press. Dr. Gruener performs consulting work, and his current activities include editing Emerging Solutions in Pain, a pain management Website for physicians; developing slide kits; and providing conference planning from a content perspective and marketing input from a clinical perspective for several medical education companies and pharmaceutical companies.
Roberta R. Ball, DO, Principal Investigator
Dr. Roberta Ball joined CRI Worldwide in 2003 and serves as the Psychiatric Medical Director of the Philadelphia division. Dr. Ball has an extensive background in academic psychiatry at the University of Medicine and Dentistry School of Osteopathic Medicine, where she maintained a clinical practice for more than 15 years. While in clinical practice, Dr. Ball taught and lectured extensively to both medical students and residents. Dr. Ball is Board Certified in General Psychiatry and has a Certificate of Added Qualification in Geriatric Psychiatry.
Dr. Ball completed her Residency in Psychiatry at Thomas Jefferson University Hospital and joined the Department of Psychiatry at Thomas Jefferson University in the Consultation and Liaison Division. At the University of Medicine and Dentistry School (UMDNJ) of Osteopathic Medicine, Dr. Ball served as Director of Residency Training, as well as the Director of Outpatient Services in the Department of Psychiatry.
Dr. Ball’s many publications include: "Dimensions of the Beck Depression Inventory-II in Clinically Depressed Outpatients", Journal of Clinical Psychology; "Screening for Major Depressive Disorders in Medical Inpatients with the Beck Depression Inventory-PC", Behavior Research and Therapy; "Use of the Beck Anxiety and Depression Inventories with Medical Outpatients", Assessment; "Further Evidence for the Construct Validity of the Beck Depression Inventory-II with Psychiatric Outpatients", Psychological Reports; "Comparison of the Beck Depression Inventories-IA and II in Psychiatric Outpatients", Journal of Personality Assessment; "Chronic Pain", The Jefferson Journal of Psychiatry.
As a Distinguished Fellow of the American Psychiatric Association (APA), Dr. Ball served as President of her local chapter and was a representative to the New Jersey Psychiatric Association and is currently a Fellow of the American Osteopathic College of Neurology. Also, Dr. Ball served on the American Osteopathic Board of Neurology and Psychiatry and continues to be a Board Examiner. Dr. Ball is currently on the Board of Governors of the American Osteopathic College of Neuropsychiatrists.
Mark Novitsky, MD, Sub-Investigator & Rater
Dr. Novitsky has been a Principal Investigator, Sub-Investigator, and a rater at CRI Worldwide since 2006. He is Board Certified by the American Board of Psychiatry & Neurology and specializes in CNS clinical research. Dr. Novitsky received his BS in Biology from Kings College in Wilkes-Barre, PA in 1975. He did coursework at Temple University in Philadelphia in 1977 and received his MD from Wake Forest School of Medicine in Winston-Salem, NC in 1982. Dr. Novitsky has extensive experience in geropsychiatric services including his work as the Medical Director of Geropsychiatric Services at the University of Pennsylvania Health Systems. He is also a member of several societies including the American Psychiatric Association, the Pennsylvania Psychiatric Society and the Philadelphia Psychiatric Society.
Elan Cohen, PhD, Psychologist, Sub-Investigator & Rater
Dr. Elan Cohen joined the CRI Worldwide team in 2007 as a sub-investigator and rater. Dr. Cohen is a licensed psychologist with several years of experience providing mental health services and conducting psychotherapy outcome research at the University of Pennsylvania. He completed his predoctoral internship and postdoctoral fellow at Penn’s Counseling and Psychological Services Center before working several years at the Center as a Staff Psychologist and Coordinator of Referral Services. His research has been published in peer-reviewed journals, and he has presented numerous empirical studies at professional conferences. The presentations were particularly focused on the efficacy of psychotherapy and its correlates. Additionally, Dr. Cohen taught several courses at the University of Pennsylvania. Throughout Dr. Cohen’s career, he has been awarded several research grants and was honored to receive several academic awards, including Penn’s prestigious 2003 Models of Excellence Award for his interventions during the 9/11 tragedy. He is an active member of the American Psychological Association and the Pennsylvania Psychological Association.
Total Quality Improvement (TQI)
CRI’s Standard Operating Procedures and conduct of clinical trials are evaluated regularly by our Quality Assurance (QA) Coordinators. CRI has a team of QA personnel along side our clinical research coordinators. Our QA Coordinators monitor all CRFs within 24 hours; a physician reviews all ECGs within 24 hours and labs within 48 hours; filing of all ECGs and labs, once reviewed by physician, is completed within 72 hours. In addition, record reviews are ongoing. The QA Coordinators implement specific tools to aggregate and analyze all findings. Reports are generated to show trends and to assess the need for process modification.
Since we have certified clinical research coordinators, continuing education is ongoing. CRI provides an accredited, annual, in-house seminar for all our staff members. This seminar and other internal workshops provide information on new developments and / or revisions to FDA, GCP and ICH guidelines.
Institutional Review Board (IRB)
CRI Worldwide utilizes centralized IRBs, including Western, Copernicus, Schulman, Biomedical, Quorum, IMTCI and Chesapeake; we can utilize others when necessary.
Publications
- K. Rickles, J. London, Ira Fox, H. Hassman, Irma Canalis and Ch. Weise, "Adinazolam, Diazepam, Imipramine and Placebo in Major Depressive Disorder: A Controlled Study," European Journal of Pharmacopsychiatry 24 (1991), 127-131.
- Karl Rickles; Robert Downing, PhD; Edward Schweizer, MD; Howard Hassman DO; "Antidepressants for the Treatment of Generalized Anxiety Disorder: A Placebo-Controlled Comparison of Imipramine, Trazodone and Diazepam;" Archives of General Psychiatry 50 (1993), 884-895.
- C.V. Bainbridge, Pharm D; GL Klein, MD; S. I. Neibart, MD; H. Hassman, DO; K. Ellis, DO; D. Manring, MD; R. Goodyear, RNC; J. Newman, MD; S. Micik, MD; F. Hoehler, PhD; kl and P. Walicke, MD; "Comparative Study of the Clinical Effectiveness of a Pyrethrin-Based Pediculicide with Combing Versus a Permethrin-Based Pediculicide with Combing;" Clinical Pediatrics January 1998, 17-22.
- Edward Schweizer, MD; Karl Rickles, MD; Howard Hassman, DO; and Felipe Garcia-España, PhD; "Buspirone and Imipramine for the Treatment of Major Depression in the Elderly;" Journal of Clinical Psychiatry 59 (April 1998), 175-183.
- "A Double-Blind Multi-Centered, Randomized, Active-Controlled, Two-Arm, Parallel-Group Comparative Study of the Efficacy and Safety Oral HMR3647 Versus Oral Clarithromycin in the Treatment of Community Acquired Pneumonia in Adults" for Hoest Marion Roussel, 1999.
- Howard Hassman, Alternative Treatments for Common Conditions, St. Louis: Quality Medical Publishing, Inc., 1999.
- F.G. Hayden, H.A. Hassman, T. Coats, R. Menedez, T. Bock, and the Pleconaril Respiratory Infection Study Group, "Pleconaril Treatment Shortens Duration of Picornavirus Respiratory Illness in Adults," 2000.
- Michael E. Thase, MD; Charlotte Kremer, MD; Heidi E. Rodrigues; J. Amsterdam; J. Apter; M. Bari; Chula Vista; H. Crabbe; S. Eisen; M. Fava; J. Ferguson; H. Hassman; S. James; N. Kalin; C. Meredith; D. Oren; L. Papp; W. Privitera; R. Riesenberg; Trivedi; T. Walsh; and J. Zajecka; "Mirtazapine Versus Sertraline After SSRI Non-Response;" presented at the ECNP meeting in Munch, Germany September 2000.
- Alan F. Schatzberg, MD; Charlotte Kremer, MD; Heidi Rodrigues; M. Bari; B. Baumel; L. Blake; S. Cheren; O. DeBattista; L. Eisner; B. Falk; S. Hand; H. Hassman; J. Heiser; L. Kerby; E. Kramer; C. Nelson; R. Riesenberg; P. Ripley; L. Rone; G. Small; A. Strauss; and K. Weiss; "Mirtazapine Versus Paroxetine in Elderly Depressed Patients;" presented at the ECNP meeting in Munich, Germany September 2000.
- W. V. Brown, B. K. Zedler, H. E. Bays, H. A. Hassman, R. R. Chitra and E. Miller; "Long-Term Efficacy and Safety of Rosuvastatin: Results of a 52-Week Comparator-Controlled Trial Versus Pravastatin and Simvastatin;" American Rosuvastatin Trialists Group submitted to Annual Congress of European Society of Cardiology September 2001.
Locations
Corporate Division:
16000 Horizon Way, Suite 100
Mount Laurel, NJ 08054
T: 856-533-5020
F: 856-235-0048
Kirkbride Division:
111N 49th Street
Philadelphia, PA 19139
T: 215-471-6859
F: 215-471-8039
Lourdes Division:
218 A Sunset Road
Willingboro, NJ 08046
T: 609-877-3181
F: 609-871-0290
Willingboro Division:
1113 Hospital Drive, Suite 202
Willingboro, NJ 08046
T: 609-877-7935
F: 609-877-2399
