PPD

JULY 16, 2024

Our recent white paper explores the many ways in which a functional service provider (FSP) engagement delivers key pharmacovigilance (PV) capabilities necessary across the product life span and across different geographical regions.

Compliance 52

Compliance Regulations Production International 52

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.

Compliance 52

Compliance Production Clinical Research Marketing 52

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Enable every aspect of your complex oncology trial.

Trials 58

Trials Clinical Trials Therapies Drug Development 58

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?

International 52

International Research Drug Development Pharmaceuticals 52

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.

Clinical Trials 52

Clinical Trials Clinical Development Trials International 52

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.”

Regulations 40

Regulations Trials Clinical Trials Science 40

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 ).

Science 40

Science Regulations International FDA 40

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.

Clinical Trials 52

Clinical Trials Regulations Compliance Production 52

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.

Clinical Trials 54

Clinical Trials Trials Clinical Research Drug Development 54

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.

Production 52

Production Trials International Government 52