Research Center Profile:
Pediatrics/Neonatology
Senders Research is celebrating its 19th 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 have enrolled more than 3000 patients and have participated in more than 100 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 screened to enrolled 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 to provide our research sponsors the best quality data.
Types of studies we have conducted:
Vaccines and biologicals
Asthma
Otitis Media
Pharyngitis
Conjunctivitis
Allergy
Formula
Antibiotics
Survey Research
ADHD
Disease of Premature Infants
Dental studies
Senders Pediatrics specializes in immunogenicity studies. Other areas of particular interest to us include:
Conjunctivitis
Pharyngitis
Allergic Rhinitis
Asthma
Community acquired pneumonia
ADHD
Respiratory Syncytial Virus (RSV)
Atopic Dermatitis
Influenza
H1N1
Meningococcal meningitis
Strep Throat
Sponsors we have worked with:
Advancis
Allergan
Alcon
Astra-Zeneca
Aventis Pasteur
Aviron
Bristol Meyers Squibb
Chiron
Connaught Laboratories
Eli Lilly and Company
GlaxoSmithKline
Hoffman-LaRoche
McNeil Pharmaceutical
Mead Johnson
Medimmune Inc.
Merck & Co., Inc.
Novartis
Pasteur Merieux Connaught
Pfizer Inc.
Ross Laboratories
Sanofi Pasteur
Sepracor Inc.
SmithKline Beecham
Tap Pharmaceutical Products Inc.
Wyeth
Wyeth Lederle
Wyeth Nutritionals
Contract Research Organizations 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
RPS
Central IRBs we have worked with:
Quorum
Sterling
Aspire
Western
Copernicus
Chesapeake
WIRB
Schulman
Studies Completed:
A study of the immunogenicity and safety of a routine vaccine in children 10 to 18 yrs. – Apr. 2013
A study of the immunogenicity and safety of a routine booster vaccine in young adults, administered 10 years after a previous routine vaccine. – Feb. 2013
An study of the immunogenicity and safety of a routine vaccine administered to children 2 to 10 years of age. – Nov. 2012
An immunogenicity and safety study of a routine vaccine co-administered with other routine vaccines administered to children in the second year of life. – Oct. 2012
A safety and immunogenicity study of a routine vaccine vs. an alternative vaccine in healthy children – July 2012
A study of a routine vaccine given as a second dose to 4- 6 year olds. – Jun. 2012
An immunogenicity study of routine vaccines given concomitantly in 11-12 year olds – Jun. 2012
A safety and immunogenicity study approximately 10 years after a previous dose of a tetanus vaccine. – Nov. 2011 – Nov. 2012
A safety and immunogenicity study of a meningitis vaccine and a tetanus vaccine. –Sept. 2012
A safety and immunogenicity study of a meningitis vaccine and a HPV vaccine. Sept. 2011
A safety and immunogenicity study of a booster meningitis vaccine. Sept. 2011 – Sept. 2012
An investigation of bacteria in the mouth. (3-8 year olds) –May 2011 – Sept. 2012
A safety and immunogenicity study of a pandemic vaccine. –Mar. 2011 -
A safety and immunogenicity study of a tetanus vaccine. 1/2011 – Jan. 2011 – June 2011
A safety and immunogenicity study of an influenza vaccine. –Nov. 2010 – Mar. 2012
A safety and immunogenicity study of a pneumococcal vaccine. –Oct. 2010 – June 2012
An evaluation of the persistence of antibody responses among children who previously received an investigational meningococcal vaccine. July 2010 – May 2011
A study of ADHD. –July 21010 – May 2011
An immunogenicity and consistency evaluation study of a Haemophilus influenza type b vaccine compared with another routine infant vaccine. June 2010 – Nov. 2012
An investigation of bacteria in the mouth (infants). June 2010 – Sept. 2012
A safety and immunogenicity study of a meningococcal vaccine in Infants and Toddlers. January 2010- Sept. 2011
A safety and immunogenicity study of a meningococcal vaccine administered concomitantly with routine vaccines infants aged 2 mos. January 2010-April 2010
A safety and immunogenicity study of a pneumococcal vaccine compared to Prevnar™ in adults and toddlers. December 2009-March 2010
A safety and immunogenicity study of a HPV vaccine given concomitantly with routine vaccines in 11-15 year olds. December 2009- Nov. 2010
An observational study of premature infants with respiratory events. October 2009-February 2010
An epidemiology strep study of children 3-12 years of age. May 2009- July 2009.
A safety and efficacy of a topical ophthalmic solution for the treatment of bacterial conjunctivitis in children. March 2009
The safety and immunogenicity of a varicella vaccine administered concomitantly in healthy children 12-23 months of age. February 2009- November 2009.
Evaluation of the perisistence of antibody responses among adolescents who previously received a meningococcal vaccine. February 2009-
An observational study of premature infants with respiratory events. February 2009
Exploratory evaluation of a two-dose schedule vs a one-dose schedule of a meningococcal vaccine in children in the US. June 2008-July 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. December 2008- February 2009.
A safety study of pediatric vaccines administered concomitantly with a meningococcal vaccine to toddlers. December 2008- October 2009
The safety, tolerability and immunogenicity of a Pneumococcal vaccine in healthy children aged 15 months to 17 years in the United States. November 2008- December 2009
The safety and immunogenicity of 2 flu vaccines administered intramuscularly in children 6 to 35 months of age. October 2008
The safety and immunogenicity of one dose of an investigational meningococcal vaccine compared with one dose of licensed meningococcal vaccine administered to healthy children 2-10 years of age. July 2008- March 2009
The safety and immunogenicity of one dose of investigational meningococcal vaccine compared with one dose of licensed meningococcal vaccine administered to healthy toddlers. June 2008-October 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. March 2008-August 2008
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
Senders Research occupies over 3000 square feet in the Cedars on the Green Health Center, whose primary occupant is Senders Pediatrics. In 2007 we moved into this 18 room facility to accommodate our growing population. 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:
Electronic medical record
-70°C freezer: Hoshizaki, model FH1-SSB
Hoshizaki RH2-AAC Refrigerator
VWR Scientific Product Freezer
ScienTemp Freezer
2 Mid-Mark Refrigerators
2 Fisher Scientific Refrigerator
Unico Centrifuge model C856
Venoscope model VT 03
Revco Lab Refrigerators with locks
Phonetics Sensaphone Temperature Alarm System. Model 1104
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.
Shelly David Senders, MD
Elizabeth Bucchieri, MD
Jill Sangree, MD
Andrea Mann, DO
Ann Witt, MD
Kristina Banks CPNP
Julia Cashera CPNP
Kelly Kelmes, CPNP
Tiffany Rybak, CPNP
Dawn Bowen, CFNP
Alycia Slaton, RN, CCRC Project Manager
Jennifer Mears, BS, CCRC Manager of Clinical Research
Nicole Leppert, BS Program Coordinator
Andrea Antologa, BS Research Coordinator
Alexandra Russ, BA, CPT Research Coordinator
Allison Himes, PBT, (ASCP) Research Coordinator
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
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.
Our site has experience working with 8 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 have been audited by the FDA, no 483 was issued.
If you are interested in contacting this center to discuss placing a clinical
trial there, please complete and send the email form below. A representative from
the research center will then follow up with you.
