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Coastal Connecticut Research, LLC |
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Center Overview
Coastal Connecticut Research, LLC (CCR) is managed by Robert M. Spitz, MD., CCI. We are a dedicated private clinical research facility. Clinical trials are conducted by Dr. Spitz, the Principal Investigator, and sub-investigators who are qualified gynecologists, also a urologist, psychiatrist, internist, endocrinologist, gastroenterologist and a female sexual dysfunction expert. Two clinical research study nurse coordinators run the clinical trials on site. Together, all involved provide a wide range of experience and broaden recruitment capabilities.
Clinical Research Experience
Dr. Spitz, Principal Investigator at Coastal Connecticut Research, specializes in pharmaceutical clinical trials in the area of Health Care for both women and men. He was one of the first Clinical Investigators to pass the DIA (Drug Information Administration) Clinical Investigator Certification Exam in Washington, DC, October 2003. Certified Clinical Investigators are pivotal to the drug development process. The DIA states, "This program will provide investigators with the skills and knowledge not only to conduct successful clinical trials but also to do so with credibility. Clinical investigators who complete the certification program demonstrate their commitment to better serving the public and improving patient care." Coastal Connecticut Research team has conducted over 30 clinical trials focusing on quality of life issues such as osteoporosis, high cholesterol, depression, overactive bladder, sexual dysfunction, irritable bowel syndrome, vaginal atrophy, hormone replacement therapy, vaginitis, hot flushes and other menopausal symptoms. A few of our clinical trials have also included men as active participants/subjects. We can also conduct trials in areas such as: Endometriosis, HPV related abnormalities, PMS/PMDD and Contraception.
We have considerable experience recruiting, evaluating, and following women and men with these complex disorders. Our investigators and study nurse coordinators have the expertise to determine and to assess proper eligibility to ensure accurate study data.
Facility Description
The Coastal Connecticut Research facility is located in New London, Connecticut. We are within 1-3 hours from major airports and within 2 miles of Amtrak train station. We are in a private building and fully equipped to successfully conduct clinical trials in-house. Most investigators have active private practices and are near our research facility. We have access to Lawrence & Memorial Hospital which is located 0.9 miles from our facility. There is ample office space for double-locked storage to store and secure study medications and study records. We have locked refrigerator, freezer, safe and filing cabinets. We have 2 patient waiting rooms, exam room and designated work space for monitoring visits.
Investigator Experience
Dr. Robert Spitz, a board-certified Obstetrician/Gynecologist serves as medical director of Coastal Connecticut Research, LLC. He is a life-long resident of southeastern Connecticut, with a B.A. degree from Dartmouth College, an M.D. degree from Boston University, and residency training in obstetrics and gynecology at the University of Rochester. With over 20 years of clinical experience, Dr. Spitz now focuses his practice on gynecology and health care research. Since 1993, Dr. Spitz has conducted clinical trials in both the pharmaceutical and medical device industries, and he has been awarded two U.S. Patents for devices for correction of urinary incontinence.
Dr. Timothy M. Barczak is a board-certified Obstetrician/Gynecologist in a solo private Gynecology practice since 2005 and was in a group private practice in Obstetrics and Gynecology for 21 years prior to. He received his B.A. from the University of Detroit, earned his M.D. from Tufts University School of Medicine and was chief resident of Obstetrics and Gynecology at the University of Rochester Strong Memorial Hospital in 1982 and 1983. Dr. Barczak acts as Dr. Spitz's covering doctor for both his private and clinical research practices. Dr. Barczak has been a sub-investigator for Coastal Connecticut Research since 2005.
Dr. Vibha Gautam, Diplomate American Board of Endocrinology and Metabolism has been in private practice since 1984. Her area of expertise is Internal Medicine, Endocrinology, Diabetes and Metabolism. She graduated 1975 from Lady Harding Medical College, University of Delhi. Dr. Gautam has been serving the southeastern Connecticut community for 16 years in Endocrinology and Metabolism. She introduced the concept of management of osteoporosis with the aid of bone density measurement to southeastern CT with single beam methodology and set-up the first local DEXA unit in 1996 at Lawrence & Memorial Hospital, New London, CT. Dr. Gautam also designed and implemented a Kidney Stone Clinic for metabolic evaluation of nephrolithiasis at Lawrence & Memorial Hospital.
Alyce Huston Hemstreet, CS, APRN is a Psychiatric Clinical Nurse Specialist specializing in women's health issues, including sexual dysfunction, eating disorders, depression, anxiety disorders and pain management. Ms. Hemstreet has published extensively on various topics within the field of psychiatry, and is co-editor of the book, Variations on a Theme, Diversity and the Psychology of Women. Ms. Hemstreet maintains a private psychiatric practice and works as an advanced practice clinician with the Department of Psychiatry at Lawrence & Memorial Hospital in New London, CT. Ms. Hemstreet has also worked with a major pharmaceutical company in developing and monitoring sexual dysfunction interviews used as screening criteria for clinical trials.
Dr. Christopher J. Morren is board-certified in Internal Medicine and has a certificate of added qualification in Geriatric Medicine. He was in private practice from 1981-1986 and is now in a dual private practice since July 1986 to present. He received his A.B. from Columbia University, New York and M.D. from the University of Connecticut. He is Chief of Internal Medicine at Lawrence & Memorial Hospital. Dr. Morren is also an Advisor for the State of Connecticut, Department of Health. His research interests centers on Internal Medicine in all phases.
Dr. Charles William Schmidt is board-certified in Urology and has been in private practice in New London, CT for over 34 years. He graduated from the Buenos Aires University Medical School and went to Hartford Hospital for his internship and general surgical residency. He spent three years at the Georgetown University Hospital, completing a Residency in Urology. He has served at the Lawrence & Memorial Hospital as Chief of Urology and has been on numerous committees. Dr. Schmidt has a special interest in prostate disease, urological tumors, erectile dysfunction and bilateral vasectomies.
SUB-INVESTIGATORS
Merrilyn Harden McNatt, APRN, is a board-certified Nurse Practitioner. After graduating from the Medical College of Georgia with a BS in nursing, she certified as a childbirth educator and in 1985 became one of Connecticut's first three international board certified lactation consultants. As a nursing educator, Ms. McNatt has taught at the baccalaureate and associate degree nursing levels and has served as a nurse consultant to local healthcare agencies. An advanced practice registered nurse, or APRN, Ms. McNatt has a master's degree in nursing from the University of Connecticut with post-graduate work completed at the University of Rhode Island in the area of family practice. A published author, Ms. McNatt has conducted research at both UCONN and URI with a focus in women's health behaviors. Her research interests center on the menopausal woman including sexual dysfunction, bladder control issues and osteoporosis.
Kathy J. Bryson, APRN received her board certification as Nurse Practitioner from University of Pennsylvania. She received her BS degree from Charter Oak State College in Connecticut. Ms. Bryson has over 20 years in the health care industry and has served as Staff RN, Nurse Supervisor and Clinician. Ms. Bryson is registered with the Drug Enforcement Administration as a Mid-Level Practitioner.
Edith E. Morrison-Morren, APRN received her B.S.N. degree from Columbia University School of Nursing, NY and her M.S.N. degree from University of Pennsylvania, PA. Ms. Morrison-Morren has served in the health care industry as an RN and Nurse Practitioner.
Eileen J. O'Donnell, APRN currently acts as another of Coastal Connecticut Research's sub-investigators and works out of Dr. Barczak and Dr Simpson's private practice offices. Ms O'Donnell received certification as a NCC Women's Health Care Nurse Practitioner in 1983 and among other certifications completed the INH Human Participants Protection Education for Research certificate in 2001. Ms. O'Donnell is an active member in numerous nursing programs, societies and networks and has held roles such as chairperson, secretary, member and founder of many Planned Parenthood of Connecticut committees and programs respectively. Ms. Eileen O'Donnell received the Nightingale Award for Excellence in Nursing in 2005.
Staff Expertise
We have qualified gynecologists, also a urologist, psychiatrist, internist, endocrinologist, gastroenterologist, a female sexual dysfunction expert, nurse practitioners, registered nurses, and support personnel trained in conducting clinical trails according to GCP guidelines.
- Two full-time study Coordinators; an RN is assigned to each study.
- Research Assistant dedicated to regulatory and patient recruitment
- Physician on site and on call after hours
Our investigators and study nurse coordinators have the experience to determine and to assess proper eligibility to ensure accurate study data.
Patient Demographics
Coastal Connecticut Research is located in New London County, Connecticut. We have a large diverse population with an estimate of over 250,000. Our research/recruiting population for the age group of 18 - 64 is approximately 160,000. We also draw from our medical practice database and patients that are referred from area physicians. Having a large number of private practice patients in our database and maintaining close relations with local physicians facilitates enrollment in these specialized medical areas. We also enhance recruiting by advertising in radio, newspaper and participate in various health fairs and speaking engagements.
Other Information
Coastal Connecticut Research, LLC uses a Central IRB and the research personnel are familiar with numerous Central IRB's and their submission requirements.
Currently Enrolling Trials
CenterWatch is listing the following trials that are actively recruiting patients at this center.
- High Cholesterol at High Risk for Coronary Heart Disease Volunteers with Metabolic Syndrome (see below for definition) and High Cholesterol at High Risk for Coronary Heart Disease
- Hypoactive Sexual Desire Disorder
- Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
- Overactive bladder (OAB) is a medical condition affecting both women and men that is characterized by a sense of urgency to urinate, usually with frequency and sometimes the need to wake at night to empty your bladder.
Urinary frequency, a symptom of OAB is typically defined as emptying of the bladder more than 8 times a day in 24 hours. Urinary leakage may be caused by many different conditions. When leakage is due to OAB, it is associated with strong sudden desires or urges to urinate, and an inability to make it to the bathroom in time.
COMPENSATION: Eligible patients will receive up to $200.00 - Primary objective of this study is to evaluate the efficacy, safety and tolerability of an investigational drug in the treatment of pain associated with Interstitial Cystitis also known as Painful Bladder
Contact Information
For more information, please contact:
Diane Palmer
Site Administrator
Coastal Connecticut Research, LLC
342 Montauk Avenue
New London, CT 06320 USA
Phone: 860-437-7092
Fax: 860-442-7270
E-mail:
If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.
