FEATURED CONTRIBUTED CONTENT

Leveraging FDA’s Expedited Programs: Now and in the Future


Leveraging FDA’s Expedited Programs: Now and in the Future

FDA is committed to advancing the development of therapies that treat serious conditions and rare diseases. As part of this commitment, FDA offers expedited programs for biopharmaceutical companies to reduce development and review timelines for new drugs and biologics that address unmet medical needs. In this webinar, Cardinal Health regulatory experts will examine FDA’s four […]

April 12, 2017 More Clinical »
Increasing Enrollment While Reducing Sites


Increasing Enrollment While Reducing Sites

After decades of delayed trial timelines, slow site setup and poor patient enrollment remain the top barriers to completing clinical studies on time and on budget. However, a new trial model has surfaced that flattens these obstacles and provides sponsors with the enrollment and budget certainty they need to more effectively plan for study launch […]

April 11, 2017 More Clinical »
The Great DTC Shake-Up: Patient perspectives on direct-to-consumer advertising


The Great DTC Shake-Up: Patient perspectives on direct-to-consumer advertising

In our ever-more patient-centric world, a key question arises – what do patients think about DTC? Health Perspectives Group, experts in patient engagement since 2002, partnered with eyeforpharma to answer this question in today’s changing environment. They contacted the Food and Drug Administration (FDA) and secured permission to reuse and update the patient portion of […]

March 7, 2017 More Clinical »
Expediting Drug Approval


Expediting Drug Approval

For patients with serious and rare diseases, time is of the essence, and the traditional drug development process may take far too long. To speed innovative new drugs to market, the FDA has established four expedited programs that allow the development process to be compressed and evidence of the drug’s effectiveness gathered as efficiently as […]

March 21, 2017 More Clinical »
The Case for Embracing the FDA’s Endorsed Data Standards


The Case for Embracing the FDA’s Endorsed Data Standards

In this white paper, we’ll discuss the guidances compelling organizations to compile data into standardized, digital datasets, the FDA’s motivation behind these changes and the benefits to — as well as the hopes of — the organizations that must submit standardized data. There is also a related podcast on this topic, which you can listen to using the […]

March 6, 2017 More Clinical »
Designing Effective Patient Assistance Programs (PAPs)


Designing Effective Patient Assistance Programs (PAPs)

While economic reforms drive sweeping changes in healthcare, the reimbursement and access landscape for specialty drugs continues to grow more challenging. For patients facing serious illnesses and their healthcare providers, navigating the prior-authorization requirements and other barriers to care can be overwhelming. Many specialty drug manufacturers are taking steps to help patients overcome these access […]

March 8, 2017 More Clinical »
Fresh Insights on FDA Data Standards


Fresh Insights on FDA Data Standards

Chiltern has recently worked with PharmaVOICE to publish a white paper and a related podcast about the FDA’s latest guidances on data standards for clinical research. I highly encourage you to check out these informative pieces if you are interested in this topic. White Paper: The Case for Embracing the FDA’s Endorsed Data Standards Download Podcast: Navigating […]

March 13, 2017 More Clinical »
Speak Out


Speak Out

Calling out Clinical Technology Think about your phone – maybe you are even reading this on it – and you’ll probably have an emotional reaction of some kind. It may or may not be a strong reaction, but odds are there is a certain and specific feeling your phone emotes in you. For something that […]

March 1, 2017 More Clinical »
The Global Alzheimer’s Crisis: New Paradigms in Clinical Trials and Longitudinal Screening


The Global Alzheimer’s Crisis: New Paradigms in Clinical Trials and Longitudinal Screening

There is scientific knowledge. And there is public perception. And often, the two collide. Nowhere is this reality more explicit than with the current state of Alzheimer’s disease research. Without a definitive cause or diagnosis – and no cure in sight – many adults see no reason to assess their risk, or determine their cognitive […]

April 25, 2017 More Clinical »
Navigating Electronic Data Submission Guidances


Navigating Electronic Data Submission Guidances

In this episode, we hear from two experts on the FDA’s regulations regarding electronic submissions. They cover issues such as what has changed over the last 3 years, the latest FDA guidance documents, reasons for complying, and deploying standards when clinical development efforts are initialized. This podcast also has a related white paper which covers […]

March 6, 2017 More Clinical »
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