This global research examines the drivers, barriers, and benefits of a unified clinical operating model from a CRO perspective. Findings show CROs are leading the adoption of modern clinical applications to increase efficiency, enhance collaboration, and improve trial performance.
It is up to pharmaceutical companies sponsoring clinical trials in the EU to have complete control of their supply chain. Understanding recent changes to the EU GDP guidelines can help achieve this as they now offer a more comprehensive guidance for temperature management during storage and transportation.
These clinical packaging strategies can be used to help successfully manage the supply of an expensive drug product throughout the duration of clinical testing. Without doing so, there could be costly interruptions or extended delays that would have a devastating impact on a company’s timeline to commercialization.
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. To ensure the timely delivery of the necessary supplies, a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design.
Can you imagine working for months to ensure your clinical supply strategy is in place for your European studies, only to have them be delayed because labeling requirements were out of compliance, and the QP or the site(s) rejected the materials you wanted to use in a trial? The purpose of this guide is to walk US-based clinical supply professionals through the labeling requirements laid out in Annex 13 of the EU GMP guidelines.
Real-world research design is more complicated than clinical trial design, its complexity due to a multitude of factors including the differing evidentiary needs of diverse healthcare system stakeholders, the differing outcome measures available to meet those needs, and the differing methodologic approaches that can be used to collect clinical, economic and real-world data. Selecting the most appropriate and cost-effective research design can be quite challenging. Read more about a developed and tested an algorithm that has proven to be useful in structuring decision-making in the design of real-world research.
There is still much to learn about whether a dysregulated gut microbiome causes disease, or whether disease leads to dysbiosis. Despite the scientific questions that remain to be investigated, several biotechnology companies have emerged with a focus on testing various approaches to developing therapies targeting the gut microbiome. This paper provides a summary of the current gut microbiome therapy development landscape and an overview of the commercialization challenges faced.
Implementing and managing a REMS program takes a distinct set of skills and expertise. Manufacturers often struggle, however, to find an organizational “home” for those responsible for administering these programs, whose roles are often spread across pharmacovigilance, drug safety and regulatory affairs functions. Read how to better prepare associates for their REMS managerial and supporting roles, and ways to bring greater awareness to REMS program design, implementation and assessment as a specialized discipline.
Since the Food and Drug Administration Amendments Act (FDAAA) was signed into law in September 2007 REMS programs have evolved in both scope and complexity but the use of new technologies to relieve the burden a REMS can place on prescribers, pharmacists, other healthcare providers (HCPs) and/or patients has not kept pace. Read more about the current state of REMS implementation today — what’s working and what’s not — and where to go from here to optimize the success of REMS by more effectively balancing risk mitigation with stakeholder burden.
Targeted oncology therapies are found only in a small fraction of patients, making it extremely difficult to identify eligible participants for clinical studies. Sponsors who rely solely on the timeworn method of asking sites that have performed well in the past to find patients in any given new study run the risk of drawing out the recruitment phase of their trials and adding substantially to their development costs. It is critical to identify from the outset the most appropriate strategies for recruiting patients. Just-in-time site activation is an approach that has proven successful in studies of targeted therapies/rare diseases and is worth considering as a solution.
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