Clinical Research Site Management
Empowering Clinical Research: Comprehensive Site Management for Optimal Trial Success
At Biotech Support Services & Research (BSS), we offer comprehensive Clinical Research Site Management services, providing a robust infrastructure and customized support to streamline your clinical research. Our services help to accelerate and diversify trials, expand patient access to research, and manage financial aspects efficiently, enabling you to focus on delivering groundbreaking healthcare solutions.
Revolutionizing Clinical Research: Expert Site Management for Groundbreaking Healthcare Solutions
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We offer access to exclusive trials tailored to your research interests and patients’ needs. By leveraging EHR data, we connect you with trials that align with your specific objectives, enhancing the effectiveness and relevance of your research efforts.
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Our financial management services are designed to reduce administrative burdens, lower costs, and improve the quality of trials. We manage your clinical trial financial processes through streamlined, automated, and customized solutions, allowing you to focus on patient care and trial execution. Our services include reimbursement analysis, contract and budget support, and regulatory overview.
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Our comprehensive research enablement and support program is exclusive to our research partners. We provide training, infrastructure support, technology, business development, study feasibility and coordination, financial management, and more. We aim to enable research sites to achieve Research Ready status quickly and seamlessly conduct research going forward.
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We offer study lead generation, pipeline management, and feasibility services, enabling research-experienced practices, sites, health systems, and hospitals to grow their study pipelines and increase the number of clinical trials they conduct.
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Our targeted site selection service helps sponsors select sites with the specific capabilities needed for efficient study startup. We consider factors such as the site's experience with study-specific procedures, access to the target patient population, recruitment plans, and supported screening and enrollment projections. We focus on regions where the disease under study is prevalent, taking into account the standard of care and avoiding sites saturated with clinical trials.
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Our Clinical Solutions Contracting Team works efficiently to execute site contracts using Sponsor Contract Templates and pre-approved contract language. We manage site contracts, provide prompt reports, and ensure timely payments to your sites. We negotiate and execute site agreements, confidentiality agreements, and budget contracts, facilitating the smooth execution of your clinical trials.
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Our site management services ensure that your research site operates smoothly and effectively. Services include site management, site training, subject recruitment and retention, standard operating procedure (SOP) development, and development of clinical trials materials.
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Our trainers, with extensive experience in research sites and major pharmaceutical corporations, offer comprehensive training in GCP and ICH standards. We support both on-site and off-site training and provide planning, organization, logistics, and customized document preparation.
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We offer custom courses to suit your specific learning needs. These include CRA Training, advanced GCP training, Data Safety Monitoring Workshops, and training on Oracle Clinical™ and Oracle Remote Data Capture (RDC).