“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.
The costs of drug development have increased exponentially over the years, while clinical trial participation and retention have decreased.1 Sponsor companies are seeking new and innovative ways to reduce costs while increasing patient participation by becoming more patient-centric. One such method is through designing a "siteless" trial. Siteless trials offer convenience to patients while being cost-efficient for sponsors.
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.
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.
NIH Rare Disease Day is an opportunity to collaborate, learn from one another, and celebrate the work already accomplished. This day enables us to be reinvigorated in our passion to advance treatments for rare disease patients and reminds us that the patient is the central point of our work. Here insights from some of the speakers at this year’s event.
Unsure if a REMS is needed during product development? This article will answer that question and give guidance if implementing a REMS is necessary.
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.
