Center Overview

Southeast Regional Research Group, Columbus, is one of four medical research sites affiliated with SERRG, Inc. With additional sites in Ludowici and Rincon and Savannah, Georgia, Southeast Regional Research Group works with a network of hospitals, government- and community-run healthcare clinics, and inpatient- and outpatient-based physicians in our mission to provide compassionate medical care in our community.

From initial contact with the pharmaceutical sponsor to the completion of the clinical trial, the physicians and staff at Southeast Regional Research Group are available throughout the clinical research experience, including but not limited to:

• Excellence in patient care
• Completion of all regulatory documents (which include site demographics to fit the patient population)
• Budget and Contract negotiations
• Hosting of scheduled site visits from the sponsor or CRO and their staff, to include personally escorting all persons involved and acting as a liaison
• Maintaining all study documents onsite in our local offices
• Maintaining all study related material to include study drug, devices and lab kits
• Performing all study related ancillary services to include, but not limited to, ECG's, phlebotomy, specimen collection, testing and storage, drug infusion, radiology services, in-house pharmacist support, and study related home health nursing staff.
• Providing Certified Research Coordinators and Nursing staff

Available 24-hours, seven days a week our Columbus site has conducted many clinical research trials since opening in 2005. The Columbus facility includes:

• A Certified Physician Investigator
• 17 Physician Investigators
• Physician Assistants
• Certified Clinical Research Coordinators
• Pharmaceutical Staff
• Research Assistants
• Marketing Department
• Regulatory Department
• Quality Assurance Department
• Compliance Committee

Clinical Research Experience

Our clinical staff members have a combined 38 years experience in medical research. In addition, they:

• are certified in Basic Life Support (BLS) and/or Advanced Clinical Life Support (ACLS);
• adhere to the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP);
• are observant of the protection of our patients in our clinical research studies and are HIPAA compliant;
• are on-call 24/7;
• are experienced in Phase II through Phase IV studies

Currently Enrolling Trials

As a research study participant, volunteers often learn much more about their medical condition and become more aware of their condition’s symptoms as well as emerging treatments for their condition. As a research facility under the governance of several Institutional Review Boards (IRBs) and the Food and Drug Administration (FDA), our patients receive thorough monitoring of their condition through more frequent testing, office visits and follow-up appointments.

Our Columbus site is currently enrolling patients in the following studies:

Pharmaceutical Studies:

• Acute Coronary Syndrome
• Atrial Fibrillation
• Crohn’s Disease
• Heart Disease
• Hypertension
• Influenza
• Osteoarthritis
• Skin Infections
• Venous Thromboembolism (VTE)
• Ulcerative Colitis

Medical Device Studies

• Hypertension

To accommodate various needs of patient volunteers, we often provide transportation, transportation reimbursement and communication assistance (i.e. loan of cell phone). In addition, qualified participants receive study related procedures and medication at no cost.

To learn more medical research or to see if you may be interested in these studies as well as upcoming studies, call us at 888-SERRG-08 (888-737-7408) or email us at newtrials@serrg.com.

Facility Description

Our medical research site in Columbus, Georgia, is a 2,600 square foot facility, centrally located in the city, within six miles of most area hospitals and within one mile of the Columbus, Georgia, Metro Airport. Our site features five exam rooms, a large IV infusion room with leather recliners and flat screen television, procedure rooms, phlebotomy room and a fully-equipped laboratory. This facility has an active medical staff of physicians and clinical coordinators to manage all clinical trials. Monitors have their own private desks with internet and telephone access, or they may use our spacious conference room when it is available. Subjects are allowed privacy in our quiet consent and exam rooms.

In 2007, the Columbus site attained the status of the “leading research site in the country” in terms of enrollment for several phase 2 and phase 3 studies for the treatment of complicated gram-positive skin and skin structure infections.

"By far the best site both in terms of numbers and quality of specimens... I do appreciate all that you did for the study and hope that we can collaborate again in the future."

- Glenn Tillotson, Replidyne, 25 March 2008

"I was much impressed with the attention to detail, communication and excellence in study execution at your site. I was thrilled with the teamwork of your group, and am very grateful that you seem to work so well with [the CRA]."

- Laura Lawrence, 06 March 2008

"I was most impressed with the staff and leadership at SERRG, Inc. and Southeast Regional Research Group. They took what could have been a very frustrating situation and turned it into an opportunity to shine. From the beginning, they took control in correcting issues and were appreciative of any and all feedback. I was impressed with the manner in which they took charge, even initiated processes, and were very proactive. This type of interaction and response is unheard of in the research industry.

I would absolutely work with SERRG, Inc. and Southeast Regional Research Group again. They would be first on the list for any cardiovascular trial, or a trial for any specialty for that matter. I highly recommend this site."

- Kimberly Cotten, CRA, 08 Jun 2009

"I have worked with SERRG on many studies and always get the same result - top enrollment but also high level of quality. On top of that, everyone on the staff is great to work with! SERRG will always be high on my list to contact to participate in studies I work on. "

- Carisa DeAnda, PharmD, Clinical Project Manager, Inclin, Inc.

Investigator Experience

With oversight from SERRG, Inc., Southeast Regional Research Group’s Principal Investigators are required:

• Completion of Good Clinical Practice Training (GCP)
• Human Participant Protections Education
• Completion of NIH Clinical Research Training and Exam
• Understanding of FDA Oversight in Clinical Research

Our Columbus site has 17 Principal Investigators who partner with Dr. Jeffrey Kingsley and Dr. Joseph Surber, CPI, in conducting clinical research trials.

Dr. Jeffrey K. Kingsley, D.O., M.S., FAAFP

Jeffrey K. Kingsley, D.O., M.S. is presently engaged in clinical research as the Chief Executive Officer of SERRG, Inc. In addition to promoting research as a core component of today’s healthcare, Dr. Kingsley is board certified in Family Medicine and continues to work in Emergency and Hospitalist Medicine. Before forming SERRG, Inc. Dr. Kingsley was Medical Director of Family Medicine and Urgent Care departments.

He began his research career with bench research in Biology and Chemistry in 1988 and proceeded into medical research in 1995. Since incorporating SERRG in 2005, Dr. Kingsley has been involved in dozens of research trials in multiple specialty areas.

His undergraduate degrees are in Biology, Chemistry, History and Cultural Anthropology, and he has a Master’s degree in Biochemistry. Dr. Kingsley is currently a member of the following organizations:

Memberships

• Fellow, American Academy of Family Physicians (FAAFP)
• Association of Clinical Research Professionals (ACRP)
• Academy of Pharmaceutical Physicians and Investigators (APPI)
• American Academy of Family Physicians (AAFP)
• American College of Osteopathic Family Physicians (ACOFP)
• American Medical Association (AMA)
• Georgia Academy of Family Physicians (GAFP)
• Association for the Behavioral Sciences and Medical Education (ABSAME)

Dr. Kingsley has received certification in the following areas:

• 2009 Certified Physician Investigator (CPI)
• 2006 Alabama Medical License
• 2004 Diplomate, American College of Family Physicians
• 2002 Georgia Medical License
• 2003 Advanced Life Support in Obstetrics (ALSO)
• 2006, 2002 Instructor, Advanced Cardiac Life Support (ACLS)
• 2002 Fundamentals of Critical Care Medicine
• 2006, 2002 Advanced Trauma Life Support (ATLS)
• 2006, 2002 Advanced Cardiac Life Support (ACLS)
• 2001 Neonatal Advanced Life Support (NALS)
• 2001 Pediatric Advanced Life Support (PALS)

Dr. Joseph G. Surber, D.O., C.P.I., FAAFP

Joseph G. Surber, D.O., C.P.I., is presently engaged in clinical research as the Chief Medical Officer of SERRG, Inc. He is board certified in Family Medicine, and currently holds faculty positions with the Medical College of Georgia, and Mercer University. Additionally, Dr. Surber is certified as a Physician Investigator (CPI) through the Academy of Pharmaceutical Physicians and Investigators (APPI) and the Association of Clinical Research Professionals (ACRP).

In addition to serving as Physician Investigator in dozens of clinical research trials in various medical disciplines, Dr. Surber continues to work as a Hospitalist. Prior to forming SERRG, Inc. with Dr. Kingsley, Dr. Surber practiced as an Emergency Medicine and Bariatrics physician, and served as Faculty and Associate Director of Hospital Medicine.

He received his Bachelor of Science degree in Biology with a minor in Music. Dr. Surber is currently affiliated with the following organizations:

Memberships

• Fellow, American Academy of Family Physicians (FAAFP)
• Association of Clinical Research Professionals (ACRP)
• Academy of Pharmaceutical Physicians and Investigators (APPI)
• Society of Hospital Medicine (SHM)
• American Medical Association (AMA)
• American Osteopathic Association (AOA)
• American Academy of Family Physicians (AAFP)
• Muscogee County Medical Society
• Georgia Academy of Family Physicians (GAFP)

Dr. Surber has received certification in the following areas:

• 2008 Certified Physician Investigator (CPI)
• 2007 Advanced Cardiac Life Support (ACLS)
• 2005 Pediatric Advanced Life Support (PALS)
• 2005 Neonatal Advanced Life Support (NALS)
• 2005 Advanced Trauma Life Support (ATLS)
• 2003 Advanced Life Support in Obstetrics (ALSO)
• 2003 Fundamentals of Critical Care Support (FCCS)

Therapeutic Areas

In 2007, the Columbus site attained the status of the “leading research site in the country” in terms of enrollment for several phase II and phase III studies for the treatment of complicated gram-positive skin and skin structure infections.

• Cardiology
• Dermatology
• Emergency Medicine
• Endocrinology
• Gastroenterology
• Gerontology
• Gynecology
• Hematology
• Infectious Disease
• Internal Medicine
• Medical Devices
• Musculoskeletal
• Nephrology
• Neurology
• Obstetrics
• Ophthalmology
• Otolaryngology
• Pain Management
• Pediatrics
• Pharmacology
• Podiatry
• Pulmonology
• Respiratory Therapies
• Rheumatology
• Trauma Medicine
• Urology
• Vascular Diseases
• Women’s Health

Staff Expertise

Partnering with physicians and patient volunteers, we believe communication and education are key factors for our staff to help patients to better understand their medical condition(s). As such, our Southeast Regional Research Group staff uses care when informing patient volunteers of their role in medical research. Once a patient has been referred to us, he or she is given a tour of our facility and meets our coordinators. Should your patient choose to participate in a clinical research study, he or she will be thoroughly monitored and frequently seen by our physicians and physician assistants.

Southeast Regional Research Group has a proven track record for success offering:

• Phase II through Phase IV studies managed from start to finish
• Proven site for patient recruitment and retention in skin infection studies
• Proven ability to successfully conduct the most challenging studies
• Large database of highly skilled, experienced and enthusiastic Investigators
• Dedicated, full-time, and experienced Certified Clinical Research Coordinators
• Access to large patient populations with cultural diversity
• Efficient and centralized contract and budget resolution
• Track record of consistently meeting or exceeding enrollment goals
• Proven and ethical patient recruitment methods including an in-house Marketing Department that creates or monitors the creation of all marketing materials
• Supporting member of ACRP and APPI

Meet the Clinical Staff at Southeast Regional Research Group

Mike Grabowski, PA-C

Gail Lynch, FNP-BC

Beverly Cody, CMA, CCRC

Shelly Conerly-Holt, CRC, B.S., LPN

Non-Clinical Staff for Southeast Regional Research Group

• Jana Harman, Corporate Administrative Assistant
• Christine Senn, Chief Operations Officer, Chair-Quality Assurance & Compliance Committee
• Sherry Lesesne, Human Resources Director
• Amy Wilkerson, Director of Marketing
• Felicia Irvin, Patient Recruitment Specialist, Columbus, Georgia
• Jennifer Hardrick, Corporate Regulatory Document Specialist
• Marisol Colmenares, Medical Administrative Assistant
• Numerous PRN coordinators and nurses