What we can do for you

T

hank you for inquiring about Oracare Research. We are a contract research organization providing a clinical facility and comprehensive support system for most oral care product manufacturer's clinical research needs. The facility is located in Sanford, a busy and growing community of Central Florida.

Oracare Research was established in 1993 and is managed by Jiten Sheth,BDS,MS. Dr. Sheth has been involved in various aspects of oral care research for several decades with universities, contract research organizations and oral care pharmaceutical companies globally.

Our state-of-the-art dental office is designed to facilitate effective clinical research. The facility is capable of handling O.T.C. as well as IND Phase 1-4 clinical trials and complies with F.D.A. and E.E.C. guidelines for Good Clinical Practices (GCP). In affiliation with other CRO’s and experts, the partnership offers comprehensive services nationally and internationally, including on-site monitoring, GMP/GCP audits, regulatory affairs, statistical services, editorial services and in-house training.

Oracare Research provides support in several phases of oral care product development. Early project planing and resource coordination is managed by regular interactions with the sponsor. Long-term planning allows a product's rapid introduction to market at the conclusion of FDA, ADA or EEC review.

Clinical strategy and method development is coordinated with the client's technical experts. Consultations with national and international scientists are possible for technical, clinical and regulatory opinions in their respective areas of expertise.

Protocol development is managed within Oracare Research and reviewed by an external Institutional Review Board (IRB) with high confidentiality. Multi-site clinical trials can be coordinated with local CRA's and staff, with on-site monitoring if required. When necessary, the clinician is available to serve as an independent examiner for a number of clinical indices at other trial sites. We regularly consult with peers and industry experts in any area of interest to optimize late-breaking technology and changing regulations.

Our diverse and representative subject population is well profiled for the various areas of common interest and can generally be enrolled at short notice. The population is well balanced for demographic and behavioral/societal trends and is highly compliant with product-use directions. Daily-supervised and long-term trials are possible with minimal population attrition.

Clinical trials at Oracare Research are conducted with efficiency. Real-time data capture allows rapid processing and transmittal to the Sponsor after appropriate Quality Assurance. Secure storage of data and investigational product assure hassle-free trial audits. Biostatistical support and comprehensive data analysis assist in prompt Final Report and publications preperation. We consult with leading experts to facilitate smooth Regulatory approval.

Market research capability is available for pilot market introductions and focus groups. The office offers a direct point of sale to oral care product consumers and can easily process Product Acceptance surveys and other market sampling. A comprehensive demographic database allows easy categorization of target groups.