Clintrac offers site management services to national and international clients to take the burden off of investigators so that they can focus on the clinical trial, and to ensure that the trial is conducted at the highest standards of quality, ethics and performance. Our team of highly qualified experienced professionals understands the expectations of Pharmaceutical, Biotechnology, Medical device industry and CRO clients. We recognize that the accurate identification of potential clinical sites is important for the overall success of any clinical trial project. Our SMO operations team has a great deal of experience in identifying the potential investigators as well as evaluating site staff, infrastructure, clinical research expertise and patient demographics. in addition to this our key strength is identifying the potential study site by evaluating the protocol, patient population and available resources in order to develop strategies that will help our clients to ensure that only the best locations and sites are presented to them for evaluation.
Our site management team
selects each study site based on the site infrastructure and
access to appropriate patient population. A patient recruitment
and retention plan distinctive to each study site is prepared,
focusing on the site's strength and experience. We have
well-established relationships with study sites and work closely
with each site to increase successful recruitment and retention
strategies.
Our SMO
service include:
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Identify
the potential sites and investigators.
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Site setup.
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Create
source document template.
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Site
specific project management.
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Prepare
site for site initiation visit.
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project
specific training for CRC's .
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Placing
trained CRCs/Study nurses at site.
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Assist the
site in ICF process.
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Assist the
site in patient recruitment.
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Employ
quality check at each stage.
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Preparing
the site for audits and inspections.
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Manage drug
accountability, distribution and logistics.
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Coordinate
central lab logistics.
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Update the
site master file at each step.
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Coordinate
SAE reporting.
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Prepare
site for close out visit.
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Resolve all
queries.
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Manage
archiving at site.
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