For Sponsor and CRO Services

Why Should You Choose SERRG?

1. What services does SERRG, Inc. offer?
2. How do you recruit patients?
3. What phases of research do you perform?
4. In what medical specialties has SERRG, Inc. conducted research?
5. How long does the initial study start-up and regulatory paperwork take to complete?
6. What percentage of your business comes from repeat sponsors?
7. What pharmaceutical companies or sponsors have you conducted clinical trials for?
8. How many successful trials have you conducted?
9. How many principle investigators are on staff?
10. Where are you located?
11. What is my role in the clinical trial?
12. What equipment do you offer?

1. What services does SERRG, Inc. offer?
SERRG, Inc. is a Site Management Organization that offers a full range of research services to fit your specialty including: execution of all regulatory documentation, completion of patient and site demographics, negotiation of budgets and contracts, hosted site visits, study document and materials maintenance, excellent physician network and nursing staff provided, all medical services including, but not limited to, ECG’s, phlebotomy, specimen collection, drug infusion, in-house pharmacy support and study related home health nursing staff, marketing for patient recruitment, retention and support and a superior quality assurance model for everything from security to lab work.

2. How do you recruit patients?
SERRG, Inc. recruits patients in various ways including: television commercials, newspaper advertisements, radio advertisements, billboards, and web articles. All forms of advertisement for patient recruitment are approved by the institutional review board overseeing the respective clinical trial, and many times supplied by the sponsor.

In addition, many of our patients participate in our clinical trials as a result of referrals from other physicians who think that the patient will benefit from the therapy offered for their diagnosis.

3. What phases of research do you perform?
SERRG, Inc. conducts clinical trials in research phases II, III, and IV.

Phase II Study-After the successful completion of phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals who are afflicted with the disease or condition for which the drug was developed.

Phase III Study-The third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling.

Phase IV Study-After a drug has been approved by the FDA, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events.

4. In what medical specialties has SERRG, Inc. conducted research?

  • Atrial Fibrillation
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Clostridium Difficile Associated Diarrhea (CDAD)
  • Community Acquired Pneumonia (CAP)
  • Complicated Skin & Skin Structure Infections (cSSSI)
  • Multiple Sclerosis
  • Parkinson’s Disease
  • Tendonitis/Bursitis
  • Type II Diabetes

We also have several clinical trials pending for the following diagnosis:

  • Acne
  • Anemia
  • Arthritis
  • Chronic Kidney Disease
  • Congestive Heart Failure (CHF)
  • Crohn’s Disease
  • Diabetic Foot
  • Endometriosis
  • Gout
  • Impetigo
  • Influenza

  • Intra-Uterine Device (IUD)
  • Irritable Bowel Syndrome (IBS)
  • Multiple Sclerosis
  • Obesity
  • Oral Contraceptives
  • Osteoarthritis
  • Pain
  • Pancreatitis
  • Post-Menopausal Osteoarthritis
  • Rheumatoid Arthritis
  • Sinusitis

5. How long does the initial study start-up and regulatory paperwork take to complete?
On average, initial study start-up and regulatory paperwork takes less than 10 business days to complete. Confidentiality agreements can be returned in 2 to 3 days and regulatory packets have a less than one week turnaround.

6. What percentage of your business comes from repeat sponsors?
A large percentage of our business comes from sponsors that we have worked with in the past. We pride ourselves in providing quality care to patients, providing clean, quality data and doing so in a timely manner. As we continue to do this, the percentage of repeat business from sponsors will continue to grow.

7. What pharmaceutical companies or sponsors have you conducted clinical trials for?

  • ALTANA Pharma US, Inc.
  • Aventis, Inc.
  • Bristol-Myers Squibb Company
  • Cerexa, Inc.
  • Cubist Pharmaceuticals, Inc.
  • Endo Pharmaceuticals, Inc.

  • J&J Pharmaceutical Company
  • Pharmaceutical Research Associates, Inc.
  • Salix Pharmaceuticals, Inc.
  • Teva Neurosciences, Inc.
  • Theravance, Inc.

8. How many successful trials have you conducted?
Since our start-up in 2004, SERRG, Inc. has successfully conducted twelve clinical trials. These trials are listed below:

Atrial Fibrillation (1)
Chronic Obstructive Pulmonary Disease (COPD) (1)
Clostridium Difficile Associated Diarrhea (CDAD) (1)
Community Acquired Pneumonia (CAP) (1)
Complicated Skin & Skin Structure Infections (cSSSI) (4)
Multiple Sclerosis (1)
Parkinson’s Disease (1)
Tendonitis/Bursitis (1)
Type II Diabetes (1)

9. How many principle investigators are on staff?
SERRG, Inc. has a total of twenty physicians that serve as investigators for our clinical trials. There are nine physicians that are affiliated in Columbus, Georgia, eight physicians in Savannah, Georgia and three physicians in Alexander City, Alabama.

10. Where are you located?
Southeast Regional Research Group facilities are headquartered in Columbus, Georgia. We also have facilities in Savannah, Georgia and Alexander City, Alabama. Presently, we are expanding into Hinesville, Georgia, Rincon, Georgia and Ft. Myers, Florida. There is planned expansion into the following states: Alabama, Florida, Mississippi, Texas, South Carolina, and Kentucky. Additionally, we contract with institutions and principal investigators and provide SMO services within their existing facilities across the United States.

11. What is my role in the clinical trial?
As a principal investigator SERRG allows you to do what you do best; take care of your patients. Our professional staff will find potential trials for you, submit all regulatory documents, negotiate an aggressive budget, and facilitate getting your trial up and running. Once a trial is active, SERRG physicians will be sub-investigators allowing you to be as involved or uninvolved as you wish to be. The sub-investigator can sign off on all normal labs and perform physical exams/procedures that the PI is not specifically needed to do. Naturally if a complication should arise, the PI will be notified immediately. Many of the study visits can be performed in our facility, such that we don’t tie up exam rooms in your office. Your patients will still come for their regular visits for non-study related issues for which their insurance will be billed as typically done.

12. What equipment do you offer?
-70º C freezer, several -10º to -20º C freezers, several refrigerators, centrifuges for blood processing, several 12 lead ECG machines, digital copiers, paper shredder, security system, emergency medicine crash carts, balance scales, Access to a full service reference lab that is within 5 minutes from the facility and is affiliated with the research center.

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