Over the past decade, biopharmaceutical companies
have increasingly turned to emerging markets as a way
to reduce clinical trial costs and timelines. Areas such
as Eastern Europe, India, and Latin America—with their
ready population of treatment naïve patients—can be an
answer to the intense competition for patients seen in
developed markets. Many of the countries within these
regions may now be considered as “emerged” countries
but yet, conducting trials in these regions does require
some special attention and expertise. Before deciding to
conduct studies in these areas, companies should have a
full appreciation for the ethical, medical, regulatory, legal,
and operational hurdles that must be surmounted for
success. Here we highlight a number of those issues and
offer our recommendations for how sponsor companies
can deal with them effectively.
The use of various social media platforms, such as Twitter, Instagram, Facebook, and LinkedIn, for dissemination of clinical trial information has created a cornucopia of possibilities enabling clinical trial performance. Characterized by a people-to-people immediacy, social media permits extraordinarily adaptive modification of study information in real-time, and it does so in a highly targeted fashion.
So often, inspections are a major source of stress in the clinical trial
environment. This is especially true when processes involved in preparing for an
inspection are reactive. But, it doesn’t have to be that way. Using industry-leading
practices and resources enables a proactive approach to mitigate—or even
eliminate—the pain points associated with preparing for inspections.
Because software development is our core competency, TrialScope continues to make a significant investment in our technology. We employ agile methodologies to ensure that we can maintain a continuing level of responsiveness as disclosure requirements evolve across registries and regions.
This white paper addresses the growing interest in quality in clinical trial execution and how workflows play an essential role by building in the steps needed to comply with TMF guidelines, reducing downstream problems. This proactive strategy limits issues caused by siloes, yielding process improvements measurable by performance metrics.
Many organisations today are experiencing unprecedented demands from regulatory authorities and consumers alike for product labelling to be made clearer and more informative. Forthcoming regulations (including the new EU MDR regulations coming into force May 2020) also require that labelling content to be published electronically in addition to print. As companies seek to continuously differentiate themselves in established markets as well as gain entry into new territories, the increase in both volume and complexity of product and market variations will have a direct impact on labelling.
The European Centre for Clinical Research Training (ECCRT) is a professional clinical research training provider focusing on the transfer of implementable knowledge for the day-to-day activities of our participants whether being new to the industry, starters on the job, or seasoned professionals. Our mission is to facilitate Clinical Research professionals to excel in their job for the benefit of patients. We aim to achieve this by providing clinical research professionals with competencies to develop new therapies for patients quicker & more efficiently, without jeopardizing quality and safety.
As the cost and complexities of drug development increase, so do the challenges of global clinical trials. Today’s sponsors must be able to manage and coordinate multiple resources, processes, and locations with speed and accuracy to design effective and efficient clinical trials. Securing a stable supply chain to deal with the uncertainties of clinical trials is critical. One misstep can have a profound impact not only on the cost and time of your trial but also on its overall success.
Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) opened an investigation into a patient complaint of mold on paracetamol (acetaminophen) tablets (1). It discovered the product was shipped by sea from India to multiple companies in the UK at temperatures reaching up to 60 degrees Celsius. Labeling for paracetamol tablets typically states they should be kept below 30 degrees Celsius. In addition, MHRA discovered the humidity levels exceeded 80 percent during shipping, which is too high for the packaging that was used.
Bringing a new drug to market can be a heavy financial burden on any pharmaceutical company. It has become even more burdensome over the last several years as the industry pushes the boundaries of innovation. This is because newer, often more-complex therapies not only increase risk in drug development but also drive costs even higher. A recent analysis of the investment needed to develop a new prescription medicine shows the total cost can be as high as $2.6 billion (1). That number becomes even more staggering when you consider the fact that only about 12 percent of drug candidates that make it to Phase I testing are eventually approved by the FDA (2). The investment companies lose as a result may be too devastating to their bottom line to ever recover.
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