CRAs are tasked with making sure all documentation and data is as it should be: current, compliant, and following the study protocol(s). Read how with cloud-based web and mobile eTMF solutions, CRAs can throw away their spreadsheets and experience the following process improvements.
Just as patients have a stronger voice in today’s healthcare marketplace, that voice should resonate earlier in the drug development process. By adopting a patient-centric approach during protocol design and in day-to-day study management, sponsors can expect improved patient enrollment and retention, as well as a cleaner study with definitive outcomes.
Patient registries assist orphan drug development by giving manufacturers access to clinical, genetic, and biological data from a large patient population. Using registries, sponsors can better understand the disease, its history, and patients’ needs, all of which benefit clinical trial design and effectiveness.
Clinical labelling is a function that has the potential to make or break a study, depending upon design and execution. A function that was once seemingly on the periphery of clinical trial management has now taken on a new level of significance with increasingly complex labelling requirements. This case study highlights the complexities involved in label design and execution and how Almac worked with one sponsor to identify and rectify a flawed design to ensure a seamless trial, an improved patient experience and enhanced overall trial performance.
This blog discusses how specialist CROs can add value and streamline processes by providing oversight of data management services delivered by another CRO. This model helps to fulfill essential regulatory obligations for biopharma companies who may lack their own internal oversight resources.
To control costs, improve efficiency, and successfully bring more drugs to market—life-changing, life-saving drugs—pharma and biopharma companies need to follow the lead of the financial industry and forward-thinking health systems. Here, we discuss how a data-driven approach to clinical trials—from patient recruitment to post-regulatory approval—can put an end to missed deadlines, failed studies, and wasted time and money.
There are no concrete instructions when it comes to RBM, and planning a successful RBM design can be challenging. Even so, we believe investing in an experienced partner to help you with RBM design is worthwhile. RBM can be an indispensable tool for your trial’s success. Following is an out of outline a criteria that could be helpful in finding the right RBM specialist.
Advancements in science and technology have helped researchers develop new treatments for some of the most common diseases known to man. For rare diseases, however, patients have limited treatment options. Advocacy groups and regulatory authorities continue to encourage rare disease research, and more and more scientists are stepping up to the task.
Life sciences companies are embracing the essential roles that real world data (RWD) and the generation of real world evidence (RWE) play in the development of new treatments for patients.This paper will explore three areas where RWD and RWE are being applied to improve the design and execution of clinical studies.
Investigator Initiated Trials (IITs) play an important role in helping sponsor companies better understand their drugs. However, managing these studies presents unique and complex clinical supply chain challenges. Download the case study to find out how Almac Clinical Services helped one biotechnology company effectively manage drug supply for multiple IIT programs.
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