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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

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.

Drugs 57
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Type 2 Diabetes: Challenges & Emergent Strategies for Clinical Research

Conversations in Drug Development Trends

Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research. DEXA (Dual-Energy X-ray Absorptiometry) is the optimal method for accurately measuring body composition in clinical research.

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

PPD

The PPD™ clinical research business of Thermo Fisher Scientific helps clients create all manner of flexible outsourcing solutions, many of which are detailed in our recent white paper, “Establishing a Bespoke Outsourcing Arrangement with Hybrid FSP/FSO Partnerships.”

Trials 98
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Leveraging FSP Solutions and Expertise to Keep Up With Regulatory Intelligence Systems Monitoring

PPD

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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What Sponsors Need to Know About Medicare Coverage Analysis

Advarra

The Association of American Cancer Institutes (AACI) recently published a white paper titled Collaboration to Develop Recommendations to Improve Trial Activation Timelines. The task force focused on three main areas of study activation: contract negotiation, budget development, and trial start up committee reviews.

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Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

PPD

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.

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How the FSP Model Augments Biotech Sponsors’ Internal Capabilities

PPD

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions.