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.
Our dedicated team of nurses, couriers and project managers deliver, come rain or shine.
Making sure a Clinical Trial visit can go ahead in the home can be a
complex process, and last month bad weather nearly stopped play on an
important Home Trial Support visit. Thanks to the commitment and
dedication from the entire team it went ahead against the odds.
For many patients, participating in a clinical trial is a major endeavor. Depending on the protocol requirements, study visits can be exhausting. There are a number of reasons why a patient may choose to participate in a trial only to drop out. Conversely, there are several approaches to proactively try to prevent this from happening. There are various methods professionals implement for patient retention. This white paper explores patient travel services as one patient retention strategy.
When planning a clinical trial for a rare disease, it is important to have a holistic understanding of your patient population. You want to be aware of where your patients are coming from, and what it is like to walk in their shoes. These patients need your trial just as much as you need them; even from the earliest stages, conceptualize your rare disease trial as an altruistic relationship between the patient population and your study.
Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
Registration Opens for Inaugural HPAPI USA Conference in October
The HPAPI global market is growing at an ever-increasing rate of CAGR at 8.6% that is projected to reach USD $31.56 Billion by 2025, with a significant segment market of HPAPI being oncology ADC which is at a CARG of a staggering 20%. The continual elevation of HPAPI potencies along with toxicity will further drive the needs for more cutting-edge containment solutions and best practices guidelines to ensure workers safety. More info >>
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. More info >>
The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
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