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.

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. 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 trials relating to diabetes, fibromyalgia, overactive bladder, flu like symptoms, arthritis obesity and respiratory Infections.

Dr. Laurence Radin is a board certified Neurologist and has been in practice with Neurologic Group PC, since 1992. Dr Radin with his highly trained clinical staff can skillfully treat and evaluate a wide variety of medical conditions of the neuromuscular system, spinal column and brain. Patients are frequently seen for conditions such as migraine headaches, multiple sclerosis, seizures, neuropathies and Parkinson's disease among many other problems. EMG, EEG, ENG Botox injections ,nerve conduction studies as well as vagus nerves stimulation studies can be conducted under the direction of Dr. Radin.

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.

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.

Endocrinology
Gastroenterology
Nephrology/Urology
Neurology
Obstetrics/Gynecology
Psychiatry/Psychology