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QUALITY
Year : 2011  |  Volume : 2  |  Issue : 1  |  Page : 28-33

Integrated monitoring: Setting new standards for the next decade of clinical trial practice


Head- Clinical Development, International Clinical Research Operations, Novartis Healthcare Pvt. Ltd., Mumbai, Maharashtra, India

Correspondence Address:
Kamala Rai
Head- Clinical Development, International Clinical Research Operations, Novartis Healthcare Pvt. Ltd., Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.76287

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The new age clinical research professional is now geared toward an "integrated monitoring" approach. A number of critical activities at the site level and at the sponsor's organization need convergence to harness rich dividends in early study start and quick close of the study. The field monitor needs full integration to ensure standard of care, train the site in protocol, select the right site, ensure regulatory support, ensure excellent project management skills, coach, support the logistics team, manage the vendor, ensure good documentation practices, develop patient recruitment and retention, lean the applicable process, as well as ensure effective site management amongst the myriad activities assigned toward developing the drug in the clinic.


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