Conversations in Drug Development Trends

MARCH 7, 2024

Are there differential financial incentives to encourage sponsors to initiate early phase clinical research under a CTA, and how do those incentives compare to incentives that exist to initiate the same research under an IND? For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. DOWNLOAD OUR WHITE PAPER Learn more about how PPD® Laboratory services can enhance your CGT projects.

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PPD

JULY 9, 2024

Biotech and biopharma companies, however, must do all of this in the face of wildly fluctuating workloads — particularly during the post-marketing phase. Download our white paper The post FSP Flex Hub Teams Maximize Efficiency Across Lifecycle Maintenance appeared first on PPD. Let’s connect.

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PPD

DECEMBER 19, 2023

As biotech and biopharma companies seek out the best solutions in increasingly competitive talent markets – and adapt to new demands, priorities and challenges – it’s important to remember that not all FSP/FSO providers are alike. Ready to fuel more efficient drug development?

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PPD

JUNE 17, 2024

For a developer using an FSO model but looking to evolve the way they undertake clinical trials, a bespoke FSP/FSO hybrid solution can provide a smooth transition to FSP outsourcing. This approach enables unbroken continuity of support and resources across clinical trial operations.

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Agency IQ

APRIL 12, 2024

ACRO’s white paper also highlights the potential for “enhanced efficiency, long-term cost savings, and faster collection of data” through risk-based monitoring and other data collection efficiencies. This also may include advice on the use of DHTs in clinical trials or post-market studies subject to the FDA’s regulation.”

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Agency IQ

FEBRUARY 21, 2024

Given the widespread use of CDISC for clinical research and HL7 for electronic health record (EHR) data, the two organizations have partnered to create mapping guides to streamline the flow of data from EHRs to CDISC submission-ready datasets, and vice versa. CMS in the United States ).

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FDA Law Blog: Biosimilars

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

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PPD

NOVEMBER 25, 2024

Clinical trials are critical for advancing medical research and bringing new treatments to market. As the clinical trials landscape continues to evolve toward increased complexity, greater efficiency and accelerated development timelines, the ability to manage and optimize site performance has become even more critical.

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Clinical Trials Trials Clinical Research Drug Development 98

PPD

NOVEMBER 18, 2024

There are many nuances to ensuring that the RI gathered and monitored is as effective as possible (as discussed in our recent white paper on the topic). Download our white paper The post Leveraging FSP Solutions and Expertise to Keep Up With Regulatory Intelligence Systems Monitoring appeared first on PPD.

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Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. no[r] a marketing product” under Lanham Act). Leading Market Technologies, Inc. , Gray Loon Outdoor Marketing. Paragon 28, Inc.

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