Clinical Operations
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Oversight of clinical trials conducted inhouse or outsourced
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Creation of clinical study plans & manuals
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Vendor(s) selection and oversight
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Clinical trial budget planning, review and monitoring
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Clinical trials start up activities & submission to Central Ethics Committee(s)
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Clinical trial feasibility, site assessment & selection, site initiation/activation, interim monitoring and site close out activities
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Monitoring oversight
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Site engagement and management
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eTMF management
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Participate in different systems testing for clinical trials conduct (i.e. EDC, CTMS, ePRO, IRT, PV systems)
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Creation, revision & implementation of clinical research standard operating procedures (SOPs)
Training
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Customized therapeutic area training
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Protocol training to improve clinical operations team efficiency & compliance
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Training research sites in protocols and protocol amendments to ensure successful clinical trial conduct
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Basic ICH-GCP training
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Other Services
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Clinical data coding with MedDRA & WHO Drug Dictionary
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​Clinical research data review and reconciliation
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Investigational Site Audit
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Oversee pharmacovigilance and safety processes. Including the review, preparation, and completion of reports of serious adverse event cases from time of receipt through complete case review