Center Overview

Senders Research is celebrating its 15th year of performing quality clinical trials! Senders Research is a subsidiary of Senders Pediatrics, a group practice in suburban Cleveland with a focus on personalized attention, patient education and state of the art technology. From humble beginnings with a single trial and 24 enrollees in our first year, we currently have over 450 active patients enrolled in 12 studies.

Since our inception, we have enrolled more than 2500 patients and have participated in more than 75 clinical trials. Our goal is to help improve the availability of quality medications and vaccines for our pediatric patients and to provide exposure to cutting edge technological advances for our families. We have a novel approach to screening and recruiting which provides us with an enviable ratio of enrolled to screened participants. We also provide personalized attention to our patients and, as a result, have an outstanding completion rate of more than 95%. Our goal is to provide our patients with the most effective care options and in so doing, help shape the future direction of research.

Clinical Research Experience

Types of studies we have conducted:

• Vaccines
• Asthma
• Otitis Media
• Pharyngitis
• Conjunctivitis
• Allergy
• Formula
• Antibiotics
• Phase 0 studies
• Survey Research

Dr. Senders and Associates Pediatric Research Program specializes in immunogenicity studies. Other areas of particular interest to us include:

• Conjunctivitis
• Pharyngitis
• Allergic Rhinitis
• Asthma
• Community based pneumonia
• ADHD

Sponsors we have worked with:

CROs we have worked with:

• Covance
• ICON
• Kendle
• Pharmaceutical Product Development (PPD)
• PRA International
• Quintiles
• Pharmaseek
• Parexel
• Inc. Research
• PharmaNet
• BRANY
• Chiltern
• i3 Research
• MDS

Facility Description

Our office location was chosen because of its proximity to hospitals, schools, libraries and other community institutions, all of which figure importantly in the development of this practice. Serving all the eastern suburbs in Cleveland, we are only 5 minutes from freeway access via Rt. 271, 20 minutes from downtown Cleveland, and a half hour from the Cleveland Hopkins Airport. Located in the Midwest, we are easily accessible by flying or driving to most of the major metropolitan areas in the country.

Equipment Available:

• -25°C Baxter Plasma Freezer with lock
• Graphic Controls Continuous Temperature Recording Device (for freezer)
• Phonetics Sensaphone Temperature Alarm System (for all cooling equipment)
• Revco Lab Refrigerators with locks
• Generac Power System 12 KW Air Cooled Prepackaged Automatic Stand-by Generator model 04675-0 and Transfer Switch model 9227-2
• Clay Adams Dynac Centrifuge
• QRS Diagnostic SpiroCard Pulmonary Function Testing Equipment
• Secure record storage and onsite archive
• Access to dry ice
• We are a CLIA certified Moderately Complex facility
• Fed Ex, UPS, DHL, Quest, and US Mail daily pick ups

The Phoenitics Sensaphone Temperature Alarm System is capable of dialing emergency telephone numbers to report an out of range temperature so immediate action can be taken to verify and resolve the temperature excursion. All cooling equipment (freezer and refrigerators) is connected to an external generator so any vaccine, drug, or sera will not be lost.

Investigator Experience

Shelly David Senders, MD
Elizabeth Bucchieri, MD
Jill Sangree, MD
Douglas Fleck, MD
Andrea Mann, DO
Ann Witt, MD
Mary Alice Dombrowski, RN, MSN, CFNP
Jennifer Brubaker, RN, MSN, CFNP
Kristina Banks RN, MSN, CPNP

Studies Completed:

• An asthma questionnaire study. Jan 2009-Apr 2009
• Exploratory evaluation of a two-dose schedule versus a one-dose schedule of a meningococcal vaccine in children in the US. Jun 2008-Jul 2008
• Evaluation of the persistence of bactericidal antibodies in adolescents and adults who received a single dose of a meningococcal vaccine 4 to 8 years earlier. Dec 2008-Feb 2009
• A safety study of pediatric vaccines administered concomitantly with a meningococcal vaccine to toddlers. Dec 2008
• The safety, tolerability and immunogenicity of a pneumococcal vaccine in healthy children aged 15 months to 17 years in the United States. Nov 2008
• Dec 2008
• The safety and immunogenicity of 2 flu vaccines administered intramuscularly in children 6 to 35 months of age. Oct 2008-Oct 2008
• The safety and immunogenicity of 2 different meningococcal vaccines administered to healthy children 2-10 years of age. Jul 2008-Mar 2009
• The safety and immunogenicity of one dose of investigational meningococcal vaccine compared with one dose of licensed meningococcal vaccine administered to healthy toddlers. Jun 2008-Oct 2008
• A safety and immunogenicity study of a meningococcal vaccine co-administered with a common pediatric vaccine as compared to another common pediatric vaccine given at 2, 4 and 6 months of age and alternatively at 15-18 months. Mar 2008-Aug 2008
• An Asthma questionnaire study. Jan 2008-Mar 2008
• A safety and immunogenicity study of two approved diphtheria-tetanus vaccines given as booster doses in children. Jan 2008
• A safety and efficacy study of a topical ophthalmic solution compared with another topical ophthalmic solution for the treatment of presumed bacterial conjunctivitis in newborns. Sep 2007
• A safety and immunogenicity study of 3 lots of an investigational pneumococcal vaccine given with routine pediatric vaccinations in infants. Sep 2007-Dec 2007
• A safety and immunogenicity study of pediatric vaccines administered concomitantly with a meningococcal vaccine to toddlers. Jun 2007-Mar 2008
• A safety and immunogenicity study of a meningicoccal vaccine when administered with pediatric vaccinations to infants. May 2007-Mar 2008
• A study to evaluate the lot to lot consistency and the safety and immunogenicity of two types of meningococcal vaccines when administered to adolescents. May 2007-Jun 2007
• A study to evaluate the immunogenicity, safety and non-interference of two common pediatric vaccines to toddlers. Dec 2006-Feb 2007
• A study to evaluate the safety and immunogenicity of two approved vaccines in adolescents. 2007-
• An immunogenicity and safety study of two doses of a meningococcal vaccine given to infants. Oct 2006-Nov 2006
• A safety and immunogenicity study of an HPV vaccine co-administered with two different meningococcal vaccines, according to different dose schedule combinations, as compared to the administration of HPV vaccine, tetanus or menenigococcal vaccine alone in females 11-18 years. May 2006
• Aug 2006
• A safety and immunogenicity study of a common vaccine in infants. Oct 2005-Dec 2006
• A study to assess the immunogenicity of a different formulation of the drug used to prevent a serious illness in high-risk infants. Oct 2005
• A study to determine the effectiveness and safety of two medications for adolescents diagnosed with a common childhood illness. 2005
• A study to determine the effectiveness and safety of two medications for children 6 months to 13 years old diagnosed with a common childhood illness. 2005
• A study to determine the effectiveness and safety of two medications for children 6 months to 6 years old diagnosed with a common childhood illness. 2005
• A co-administration study of a meningitis vaccine and another vaccine. Nov 2006-Mar 2007
• A study of two types of a medication for the treatment of a common childhood illness. Aug 2005
• A follow-up study for two tetanus vaccines in adolescents. Feb 2005 -Jun 2005
• A study of an ointment vs. an oral medication in children with infected skin conditions. Feb 2005
• A safety, tolerability and immunogenicity study of two types of MMR vaccines in toddlers. Oct 2004 -Apr 2005
• A safety and relative efficacy study of an intranasal flu vaccine versus intramuscular flu vaccine in children. Oct 2004 -Oct 2004
• An extension study of two types of an MMR vaccine in children. Aug 2004 Apr 2005
• A study to evaluate the immunogenicity, reactogenicity and safety of a combined vaccine vs. an approved, recommended vaccine co-administered with other approved, recommended vaccines in health infants and toddlers. Aug 2004 – Feb 2005
• A double-blind, randomized, controlled study to evaluate the immunogenicity and safety of herpes simplex candidate vaccine in healthy HSV seronegative and seropositive female subjects aged 10-17 years. Mar 2004 Jun 2005
• A phase IIIb, open, randomized, controlled, multicenter study of the immunogenicity and safety of hepatitis A vaccine administered on a 0, 6 month schedule concomitantly with other recommended vaccine in healthy children 15 months of age. Sep 2003 -May 2004
• A phase III, double-blind, randomized, comparative, multi-center study of the immunogenicity and safety of three doses of hepatitis B vaccine compared to licensed hepatitis B vaccine in the first two weeks of life. May 2003 -Mar 2004
• A randomized, multi-center, placebo and active-controlled, double-blind, therapeutic confirmatory study evaluating the safety and efficacy of inhaled medication to placebo. Apr 2003 -Jul 2003
• A phase III, open-labeled, multi-center, clinical study of the safety of DTPa when administered as a booster dose at 15-18 months following primary immunization in two previous studies. Feb 2003 -Dec 2003
• A phase IIIb, open, multi-center study of the immunogenicity and safety of one dose of inactivated hepatitis A vaccine administered to healthy children who were seropositive for hepatitis prior to a primary vaccination course and to a control group of healthy children who are non-immune for hepatitis A. Dec 2002 -Jul 2003
• A phase III, observer-blinded, randomized, multi-center, clinical study of the safety, immunogenicity and consistency of three manufacturing lots of a dTpa candidate vaccine as compared to a US licensed Td vaccine. Nov 2002 -May 2003
• A comparison of the safety, tolerability, and immunogenicity of a refrigerator-stable measles, mumps, rubella, and varicella combination vaccine (refrigerated) versus (frozen) in healthy children. Oct 2002 Feb 2003
• Combination vaccine. Jul 2002 -Mar 2003
• A phase III, open-labeled, randomized, multi-center, clinical study of the safety and immunogenicity of a primary series of combination candidate vaccine co-administered with other recommended vaccines to healthy infants at 2, 4, And 6 months of age as compared to the separate administration of recommended vaccines and to combination candidate vaccine co-administered with Hib. Apr 2002 -Aug 2002
• Safety and immunogenicity of tetanus and diphtheria toxoids adsorbed combined with component pertussis vaccine compared to tetanus and diphtheria toxoids adsorbed in adolescents and adults 11-64 years of age. Feb 2002 – Mar 2002
• A phase III, open-labeled, randomized, multi-center, clinical study of the safety of a primary series of combination candidate vaccine co-administered with Hib and pneumococcal vaccine to healthy infants at 2, 4, and 6 months of age as compared to the separate administration of recommended vaccines. Dec 2001-Apr 2002
• A comparison of the safety, tolerability, and Iimmunogenicity of MMR manufactured with recombinant Human Albumin (rHA) versus MMR manufactured with pooled-donor Human Serum Albumin (HSA) in healthy children 12 to 18 months of age. Dec 2001-Oct 2002
• A randomized, placebo-controlled trial to assess safety, Ttolerability, and immunogenicity of influenza virus vaccine and measles, mumps, rubella, and varicella vaccines administered concurrently to healthy children. Jun 2001-Oct 2001
• A multi-center, randomized, double blind, placebo-controlled, parallel group study of antibiotic syrup in pediatric subjects 6 months to 11 months of age. May 2001 -Jul 2001
• Administration of frozen measles, mumps, rubella, and varicella vaccine to healthy children at 4 to 6 years of age. Apr 2001 -Jan 2002
• Open, randomized, multi-center study of the safety, tolerability, and immunogenicity of frozen MMRV given concomitantly versus not concomitantly with other pediatric vaccines in healthy children 12 to 15 months of age. Jan 2001-Jun 2001
• Safety and immunogenicity of three lots of tetanus and diphtheria toxoids adsorbed combined with five-component pertussis in adolescents 11-17 years of age. Jan 2001-Aug 2001
• The effect on stool characteristics and tolerance in infants fed iron fortified infant formulas. Feb 2001 -Mar 2001
• A phase I double-blind, randomized, placebo-controlled study of two doses of live attenuated human rotavirus vaccine at different virus concentrations in healthy infants (at 2 months of age) following a 0, 2 month schedule and previously uninfected with human rotavirus. Dec 2000 -Sep 2001
• A phase III open, randomized, multi-center study of the safety, tolerability, and immunogenicity of frozen MMRV given concomitantly with other pediatric vaccines in healthy children ages 12-15 months. Sep 2000 -Jan 2001
• A phase II randomized, control study to determine the safety and immunogenicity of two combination vaccines in healthy infants. Jan 2000 -Jun 2001
• Comparative safety and efficacy of antibiotic and antibiotic suspensions in the treatment of children with acute otitis media. Jan 2000 -Apr 2000
• A phase IV, open, comparative, multicenter study of the immunogenicity and safety of hepatitis A vaccine on a 0, 6 month schedule, administered by intramuscular injection, either to children aged (1) 15 to 18 months old or (2) 11 to 13 months old, when compared to 23 to 25 month-old children; and to determine the immune responses following co-administration of routine childhood vaccines, DTPa and Hib in the 15 to 18 month age group. Oct 1999 -Jun 2000
• A phase III open, randomized, multi-center controlled study of the safety and immunogenicity of three doses of combination vaccine administered at 2, 4, and 6 months following a birth dose of HBV compared to three doses of combination vaccine administered at 2, 4, and 6 months without a birth dose of HBV. Mar 1999 -Sep 1999
• A multi-center growth study of a term infant soy-based formula with reduced phytate. Nov 1998 -Sep 1999
• A phase III, blinded, randomized, multi-center study evaluating the clinical consistency of three lots of MMR and comparability to MMR vaccine administered to healthy children 12-18 mos. Sep 1998 -Feb 1999
• Efficacy and safety of higher doses of antibiotic in difficult to treat otitis media. Nov 1997 -May 1998
• A study of the safety and immunogenicity of initiating a primary vaccination series of DTPa administered at 2-4-6 months with combination vaccine and completing the series with combination vaccine and DTPa. Jun 1997 -May 1998
• A single-blind, randomized, multicenter study to assess the safety and efficacy of 5 days of antibiotic every 12 hours compared with antibiotic every 24 hours in the treatment of acute otitis media in infants and children. Mar 1997 -Jun 1997
• A comparison of the safety and efficacy of every 12 hour antibiotic and every 12 hour antibiotic in the treatment of otitis media in children. Dec 1996 -Feb 1997
• Acetaminophen suspension and Ibuprofen suspension in the treatment of febrile children. Nov 1996
• A tolerance to 3 forms of experimental soy formula in healthy, term infants. Mar 1996 -Jan 1997
• A single-blind, immunogenicity and safety study to determine the consistency of consecutively released lots of rotavirus vaccine. Apr 1995 -Dec 1995
• Safety and tolerability of combination vaccine to reconstitute Hib compared to combination vaccine and Hib given concomitantly, but at separate sites. 1995
• Comparison of the efficacy and safety of antibiotic every 12 hours for ten days and antibiotic every 12 hours and antibiotic every 8 hours in the treatment of acute otitis media in children. Nov 1993

Staff Expertise

Carrie E. O'Neill, BS, CCRC
Executive Director of Pediatric Research
11 years experience in clinical trials

Alycia Slaton, CCRC
Project Manager
8 years experience in clinical trials

Lindsey Mooney, BS
Clinical Research Coordinator
3 years experience in clinical trials

Jason Soltis, BS
Clinical Research Coordinator
2 years experience in clinical trials

Patient Demographics

Our patient base of 7800 patients is drawn from a diverse racial, cultural and socioeconomic base. We are located in one of the inner ring suburbs of Cleveland, Ohio, known for its diversity and have patients from over 80 different countries represented in our practice. Demographically, we are 60% Caucasian, 30% African American and 10% Asian. 10-15% of our practice is on Medicaid and we have a wide spread in socioeconomic groups represented. 50% of our patient population is drawn from a 3-5 mile radius but the remainder comes from up to 50 miles away. As you can see, we can provide excellent diversity for any study undertaken.

Other Information

Our site has experience working with 7 different central IRBs and do not require approval from any organization other than an IRB in order to participate in your clinical trial. Our regulatory specialist guarantees that regulatory documents will be submitted to the IRB within 5 business days of receipt at our Site. In many cases this is actually accomplished much faster. The average turnaround time from submission to approval is 3 weeks.

We were audited by the FDA in January 2004, no significant findings were noted and no 483 was issued.

Contact Information

Carrie O'Neill, BS, CCRC
Executive Director of Pediatric Research
Senders Research at Senders Pediatrics
2054 South Green Road
Cleveland, OH 44121
USA
Phone: 216-291-9210
Fax: 216-291-8688
EMail: research@sendersresearch.com
Web Site: http://www.sendersresearch.com

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.