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By Anna Lukyanova, COO, Arriello | FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your company fall short. |
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| My Worst Nightmare In RTSM: Accidental Unblinding | Article | By Sheri Lillis, Medidata, a Dassault Systemes company | Learn how collaborative efforts from study managers, supply managers, biostatisticians, designers, and clinicians can better protect the blind in clinical trials and prevent accidental unblinding. |
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| 3 IRT Tactics Being Used To Streamline Supply Logistics | Article | By Maxime Schuchewytsch, IQVIA Technologies | Shipping and storing leading-edge therapeutics require complex logistics, but enhanced automation and process simplification ensure that sites and patients have the drugs they need when they need them. |
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