Research Center Profile:
Coastal Connecticut Research, LLC
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.
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.
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.
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. Edward J. McDermott was board-certified in Internal Medicine in 1985, and Board Re-Certified in 2006. He has been in private practice
since 1981. He received his M.D. from the Manila Central University College of Medicine, Philippines. Dr. McDermott was selected by the
New London County Medical Association as "Outstanding Physician of the Year". He has been a Senior Attending Physician at Lawrence &
Memorial Hospital in New London since 2000 and is the Medical Director of Fairview Nursing Home in Groton. Dr. McDermott was a former instructor for the Yale School of Nursing. Dr. McDermott joined Coastal Connecticut Research in 2008, his research interest’s centers on Internal Medicine in all phases. He has been selected to be a Principal Investigator for several trials relating to diabetes, fibromyalgia, overactive bladder, flu like symptoms, and respiratory Infections.
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.
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.
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.
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.
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.
Coastal Connecticut Research, LLC uses a Central IRB and the
research personnel are familiar with numerous Central IRB's and
their submission requirements.
Diane Palmer
Site Administrator
Coastal Connecticut Research, LLC
342 Montauk Avenue
New London, CT 06320
USA
Phone: 860-437-7092
Fax: 860-442-7270
EMail: ccrvolunteer@gmail.com
Web Site: http://www.CCRvolunteer.com
The following trial(s) are actively recruiting patients:
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.
