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Digitize Instructions for Use (IFU) to Comply with EU MDR

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The regulation brings digital enablement to the forefront, compelling electronic instructions for use. EU MDR is turning digitization on its head. This new regulation, which goes into effect Ma…
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Clinical projects (you or your vendors/CROs) are putting them at Risk by 80%…

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20% of risks are addressed by teams in clinical projects. 30% of the risks or either siloed or trapped in functions. 50% A vast majority (50%) are unreported and lost. If you kno…
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Why Combining Performance, Oversight, Risk and Compliance are very important for your Clinical Development?

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Unfortunately, most sponsors and CROs use multiple applications to manage their clinical studies. Integrating multiple applications may be challenging for example reporting through multiple ap…
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Why sponsors should opt Configurable IRT system, before opting any custom version?

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Clinical trials are more complex than ever and a robust, reliable & cost efficient clinical supply strategy is vital more than ever before. The number and complexity of issues affecting supply…
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Are You Aware of Other Countrie’s Regulatory Requirements?

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To enter into a market, biopharmaceutical companies should have information of local regulations irrespective of the type of drug. Tracking the local regulations of semi and non-regulated markets …
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