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Found 33 results for label/Berita.

PPD Inc | Our Solutions
Regulatory Affairs for FSP

PPD FSP regulatory affairs solutions help navigate regulatory approval and market access with comprehensive end-to-end regulatory services.

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Real-World Data’s Role in Solving for Diversity in Clinical Research

Learn how using RWD and RWE to supplement trials provides understanding of safety and efficacy and effective off-label use.

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PPD Inc | Our Solutions
Peri and Post-Approval

Biopharmaceutical companies are needing more and more evidence to prove value and effectiveness in post-approval settings, including how to communicate this evidence to payers, health authorities and other decision-makers.

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PPD Inc | Our Solutions
GMP Lab Capabilities

Learn more about the capabilities PPD Laboratory Services’ GMP lab offers to meet customers’ needs from cell-based assays to stability testing.

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Regulatory Insights: Regulatory Intelligence Informs Sound Clinical Trial Strategy

Discover how Regulatory Intelligence is used in the pharmaceutical product development process through helping to formulate clinical trial success.

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Devices/Diagnostics: Emergency Use Authorizations During the COVID-19 Pandemic

Learn more about the increased uptake of Emergency Use Authorizations (EUA) for medical devices during the COVID-19 pandemic.

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Key Considerations for Successfully Planning a Submission

Learn the importance of strategy formulation and regulatory engagement for planning a successful ISS/ISE submission.

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Success Factors for eCTD Implementation in Mainland China and Taiwan

PPD experts discuss advances for eCTD implementation in mainland China and Taiwan and detail three critical success factors for readiness.

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The Complementary Roles of Wearables and Patient-Reported Outcomes in Patient-Focused Drug Development: Spotlight on Oncology Trials

Researchers incorporating wearables into their work should think of them as complementing — rather than replacing — insights from PROs.

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