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Harnessing AI and Real-World Data: The Future of Clinical Development

PPD

The pharmaceutical industry is currently experiencing a significant transformation. The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. Ready to learn more about convergence of real-world data and technology for clinical trials?

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CMC Content for Global Clinical Development of Pharmaceuticals

The Premier Consulting Blog

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. QOS – optional Module 3.2.S QOS – optional Module 3.2.S

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Redefining Acceleration of the Drug Development Journey

PPD

As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. Accelerate your drug development and clinical trial goals and benefit from our 360° CDMO and CRO solutions and expertise.

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The Power of Personalization Amid the Changing CRO Landscape

Conversations in Drug Development Trends

These survey results also highlight the importance of evaluating a variety of potential CRO partners of different sizes to choose the best match for your clinical development goals and corporate culture.

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Understanding Market Exclusivity for Orphan Drug Products

Cytel

Here we explore the evolution and impact of market exclusivity policies in the EU and US, highlighting their role in fostering innovation and accessibility in rare disease treatment. Market exclusivity for orphan drugs traces back to the early 1980s in the United States, with the landmark Orphan Drug Act of 1983.

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Global Planning to Local Execution Market Success

Cytel

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing.

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Hybrid FSP/FSO Solutions Enable Flexibility and Agility to Keep Biotech Trials On Time and On Budget

PPD

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

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