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Site Management Services

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:

 

Identify the potential sites and investigators.

Site setup.

Create source document template.

Site specific project management.

Prepare site for site initiation visit.

project specific training for CRC's .

Placing trained CRCs/Study nurses at site.

Assist the site in ICF process.

Assist the site in patient recruitment.

Employ quality check at each stage.

Preparing the site for audits and inspections.

Manage drug accountability, distribution and logistics.

Coordinate central lab logistics.

Update the site master file at each step.

Coordinate SAE reporting.

Prepare site for close out visit.

Resolve all queries.

Manage archiving at site.

 

 

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