Q. What are the areas of clinical interest at Senders Research?
Types of studies we have conducted include:
- Allergy and Asthma
- Otitis Media
- Formula Vaccines and
- Atopic Dermatitis
- Diseases of Premature Infants
We welcome requests to engage in clinical trials in other areas. Our turn around on questionnaires is usually within 72 hours. We have recently expanded our practice to age 23 and we provide Student Health services to a local college serving over 1000 students so that we are now able to engage in trials enrolling both children and adults.Q. What is the demographic base for Senders Research?
Our base of 7500 patients is drawn from Senders Pediatrics, a practice that services patients from birth to age 23 with a diverse racial, cultural and socioeconomic base. We are located in South Euclid, Ohio, one of the inner ring suburbs of Cleveland known for its diversity and we serve patients from over 80 different countries. Demographically, we are 60% Caucasian, 30% African American and 10% Asian. Ten to fifteen percent of our practice is on Medicaid, and we have a wide range of socioeconomic groups represented. Fifty percent of our patient population is drawn from a 3-5 mile radius, while the remainder, come from up to 50 miles away. For sponsors interested in FDA mandated diversity, we provide it all. Q. What is the research facility like at Senders Research?
Senders Research occupies over 1000 square feet in the Cedars on the Green Health Center, 2054 South Green Road, South Euclid, Ohio 44122, whose primary occupant is Senders Pediatrics. Monitors are comfortably situated in one of our spacious conference areas, each of which has natural lighting and access to secure wireless and wired internet capability. A full blinded laboratory space is available for studies that require such specialization.Q. How quickly can Senders Research get up and running on a clinical trial?A.
From the time we agree verbally to participate, we can mobilize our department to begin enrolling within 3 weeks. We use all central IRBs and the contracting process is very streamlined with a minimal of individuals involved in signing off on the project. Although we prefer to be engaged in a clinical trial from the beginning, we can often add on to a study with ease. In fact, we have been high enroller on a number of projects for which we have been an add-on site following the initiation of the rest of the sites.Q. Does Senders Research have written Policies and Procedures?A.
Absolutely. We will be happy to share this living document with any sponsor.Q. What is the policy on responding to monitoring letters?A.
Our policy is to respond rapidly in writing, often within 2 business days. This insures that we have received the monitoring concerns and that we have formulated a response to deal with the concerns addressed. We solicit feedback. In fact, on a number of occasions, we have actually solicited sponsor audits to help strengthen our policies and procedures.
Q. Has Senders Research ever been audited by the FDA?A.
We were audited by the FDA in January 2004; no significant findings were noted and no 483 was issued.