| Site Management |
| PERC’s clinical operation team is committed to quality service. |
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The team:
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Facilitates and assures that trials are conducted under the applicable regulations and
International Conference on Harmonization GCP Guidelines |
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Combines speed, accuracy, efficiency, and accountability |
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Provides CRAs skilled in monitoring and regulatory compliance issues |
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Trains CRAs to protocol-specific and disease-specific indications |
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Assigns an experienced clinical trial manager to act as liaison to all parties |
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Adheres to the appropriate internal standard operating procedures (SOPs), adapts to the client’s or PERC’s,
or creates customized SOPs specific to the project’s needs |
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Acts as liaison for participating Site IRB affairs and approvals |
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Implements and/or facilitates U.S. and governmental submissions and correspondence based on the client’s needs |
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PERC tailors services to project-specific needs:
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Trial Set-up: Investigator recruitment, pre-trial site qualification visits, and management of site/third-party vendor contract/budget negotiations |
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CRF development or review |
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Subject safety and regulatory compliance |
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Site team training in all facets of protocol and trial management |
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Initiation, interim monitoring, and close-out visits |
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Subject safety and regulatory compliance |
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Acquisition and delivery of trial supplies |
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Clinical site/third-party vendor payments |
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Expediting accurate, clean and supportable protocol acquired data |
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Collection and archiving regulatory documentation |
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Quality assurance reviews/FDA audit prep |
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