“The Korean pharmaceutical industry has been accelerating investments in open innovation and focusing on R&D for entry into overseas markets,” says Deborah Chee, president, Korean National Enterprise for Clinical Trials.
Every biopharma company talks about putting the patient at the center of everything they do, incorporating the voice of the patient and being patient-centric. However, very few companies are actually doing it. Why is it so hard to conduct clinical development in a patient-centric manner? What actions can we take in 2019?
You just wrapped up a productive meeting with the FDA. The FDA reviewer has agreed to your clinical strategy. Your leadership team is excited and cannot wait to launch the clinical trial.
“Patient-led drug development” has matured in recent years from an industry buzzword to a maxim practiced in pockets of pharma organizations each day. Yet, much more can be learned by looking through the patient lens, deeply considering their needs, and focusing on their quality of life. In recent years, companies have galvanized their efforts to develop additional methods for gathering patient input, to redesign clinical programs that improve patient experiences, and to track surrogate measures of “patient-centricity” at key stages.
When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.
For biopharmaceutical sponsors, clinical trial data are both the greatest organizational asset and the greatest challenge. This paper discusses the principles of data governance and how they are used to build a business intelligence framework that advances data quality, acquisition, and integration to deliver actionable information for use across the drug development enterprise.
How can researchers identify participants’ overall level of suggestibility and then focus on the minimization of this characteristic to solve the issue of suggestibility in clinical trial?
Genetic testing is making it easier to identify patients for clinical trials. However, genetic testing in the context of clinical trials raises raise important ethical issues, including ones related to informed consent and disclosure of results. Genetic counselors can play a crucial role in helping sponsors address these operational and ethical issues, making trials more efficient, more patient-centered and, ultimately, more successful.
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Every biopharma company talks about putting the patient at the center of everything they do, incorporating the voice of the patient and being patient-centric. However, very few companies are actually doing it. Why is it so hard to conduct clinical development in a patient-centric manner? What actions can we take in 2019?
Social media is no longer just a conduit for digital advertising; instead, it has become a powerful tool that pharmaceutical companies use to identify, listen to, engage, and collaborate with patients to improve drug discovery, development, and utilization.
There is more investment in lupus drug development than ever before, bringing renewed hope that these investments will expand our knowledge of the disease and how it’s treated. A key reason for this renewed hope is the patient voice, a factor that is even more critical in lupus because the disease impacts each person differently.
As we enter the 2019 labeling landscape—with changing regulations and slashed submission timelines—producing labels with 100% accuracy is proving to be increasingly complex and load-bearing for clinical supply teams. In the months to come, here are a few key topics that we are keeping an eye on.
Bryan Clayton, Vice President, Strategic Solutions, YPrime recently presented a webinar on IRT technology. This article recaps the discussion on IRT terminology, SDLC methodologies and how different approaches can save time, risk and cost.
As companies are looking to reduce their supplier base and shifting towards more strategic relationships with key suppliers to achieve economies of scale, learn how contract suppliers can benefit from developing strategic partnerships with other vendors and operating as one entity.
With such abundant clinical trial opportunities in China, and such a wide range of innovative eClinical technology available to take advantage of them, there has never been a better time to be a clinical researcher.
The industry is seeing continued regulatory guidelines aimed at moving sponsors and technology companies to modernize clinical studies. In addition to that a common challenge is a breakdown in communication throughout the study lifecycle.. Kevin Landells, Vice President of Project Management at Cenduit, shares his insights on an eClinical technology provider consistently achieve client satisfaction.
