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CEAR |
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Service Specifics What we do Establish fully OHRP-compliant IRBs *** Strengthen existing IRBs through P&P's and member education *** Develop institutional P&P's and train intradepartmental support personnel *** Establish and document FWA eligibility *** Maintain research-related HIPPA compliance *** Establish program evaluation capabilities *** Provide or develop direct research support personnel *** Develop publication-oriented clinical research programs ad provide statistical analysis capabilities *** Develop research programs within graduate medical education departments *** Develop protocols and related documentation in support of IND/IDE applications | ||||
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Experience Our qualifications All CEAR consultants have extensive experience in their specialities, hold graduate degrees and most have been with the company since its beginning. We establish teams on a prn basis, drawing from a pool of qualified consultants and sub-contractors. Staffing is designed to match individual client requirements. References from past and current clients are available. | ||||
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On-Site How we coordinate with your staff As with contracting, CEAR will work to determine the most cost-effective and appropriate approach. CEAR will provide some or all of the staffing necessary to achieve site goals or will train site in-house employees to achieve the same outcomes. | ||||
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Contracts How we determine contract cost CEAR will negotiate contracts on either a pro-rated hourly/daily schedule or in response to a pre-determined scope of work. Rates will vary based on contract length, effort support provided by site, and level of professional expertise required. | ||||
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Rationale Why use us instead of do-it-yourself The establishment and maintenance of an Office of Human Subjects Protections, an IRB, a compliance program, a training program and the development of documentation costs resources beyond basic salary and include continuing education, recruitment, training and professional development to maintain the infrastructure. Using a contracted turn-key service such as CEAR can be more cost effective, eliminate start-up delays and provide more protection with compliance. | ||||
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