Mallory Factor, chairman of IntraBio, has worked with regulatory agencies in both the U.S. and Europe on matters relating to clinical development programs. In doing so he had the opportunity to observe the obstacles that serve to delay and even restrict novel orphan therapies from getting to patients. He believes orphan drug developers and the FDA must collaborate more closely to bring more treatments to approval.
Clinical research patients are compensated for their participation in clinical trials. The compensation is based on the burden the trial imposes on the patient and is vetted through an institutional review board, so patients are not overly influenced by financial gain to enroll.
According to a report, the Institute for Clinical and Economic Review (ICER) is considering offering a service, for a fee, to pharmaceutical manufacturers whereby ICER would provide guidance on clinical trial design.
Despite changing demographics in aging populations, regulatory guidance specific to drug development for geriatrics has been limited, with guidances dating back to the 1990s.
Caregivers are an integral part of the care team and are involved in everything from medication choice to adherence strategy. Yet, they’ve often been an afterthought for life sciences companies, even as the industry focuses on patient centricity.
How are consumers engaging with their healthcare in today’s environment and what drives engagement, and what hinders motivation or ability to engage? This study explores these questions.
This paper looks at validation of Software-as-a-Service (SaaS) solutions and provides relevant points to consider when developing a risk-based approach to validation.
How IRT vendor relationships can ensure high quality builds that meet pharma companies' needs and avoid the potential pitfalls associated with RTSM.
Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
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Strong marketing service strategies are built on a strong foundation of deeply understanding the market, customer needs, and the decision-making processes. Continue reading to learn how to elevate your organization’s credibility and service marketing plans.
Understand how relationships, experience, procrastination, support, and accessibility play a role e-clinical innovation in part 3 of this series.
Welcome back to our three-part series discussing some of the lessons we have learned in our ten years of e-clinical innovation. In part one, we discussed how fast things have moved in ten years, the constant of change in regulations, the limits of technology for solving business challenges, the importance of training for compliance, and the increasingly global landscape of clinical research.
With study protocols are becoming more complex with changes that require amendments it is crucial to find a partner that can define, build, test, confirm, and deploy quality studies.
IRT USA 2018 resonating themes - the need for better project management and never losing sight that the patient is at the center of everything we do.
