Despite the best intentions, most companies will struggle to execute new technology selection and implementation. This fate may be more pronounced in the biopharma clinical development arena where the highly regulated, conservative, and somewhat luddite nature of our industry makes us averse to adopting and implementing new technologies.
Patient-centricity is not just a buzzword. At Novo Nordisk, we recognize that if we want to develop innovative treatments for patients living with chronic diseases, it is essential to form meaningful partnerships in which our patients’ expertise, knowledge, and experience are included and put into action. It was this radical shift in thinking that led to the creation of the Novo Nordisk Disease Experience Expert Panel (DEEP), a network of patient experts and advocates. This shared commitment to forming a true partnership, where patients are routinely included and guide every part of our care delivery model, immediately resonated and took off. Since the program launched in 2015, it has grown from 15 members to more than 120 members from over 20 countries across multiple therapeutic areas — and we are still growing.
There is more focus than ever before on tailoring treatment plans to the unique needs of patients. One way to ensure we as an industry are delivering the most value is by examining real-world data (RWD) throughout the drug development process.
Technological innovation is ongoing and is impacting all aspects of clinical studies, from study start-up through close out. While the shift to digital technologies is pervasive, the informed consent process remains paper based in many clinical trials around the world. Given its inherent inefficiencies and the increasing complexity of clinical studies, the current approach can raise challenges with respect to quality, compliance, and participant understanding. Considering this, sponsors must find new ways to ensure that potential study participants are fully informed, despite the complicated information provided.
For a patient with a debilitating disease, such as pulmonary fibrosis (PF), moments of hope can be few and far between. Many of these patients search desperately for new therapies to improve their quality of life, or possibly cure their condition, sometimes outside of the approved treatments prescribed by their healthcare providers.
Since its founding in 2012, the Society for Clinical Research Sites (SCRS) has advocated for rapid and accurate site payments. With her extensive background in clinical research, SCRS founder Christine Pierre had an in-depth understanding of the complexities of the industry and the need for key stakeholders to prioritize timely and accurate site payments using intuitive systems.
Heart failure with preserved ejection fraction (HFpEF) remains one of the greatest and most challenging unmet needs in cardiovascular (CV) medicine. In contrast to the significant advances being made in the treatment of heart failure with reduced ejection fraction (HFrEF), little has changed in the approach to treating HFpEF in decades. The lack of effective treatment options is not due to the lack of pipeline activity in this indication but rather due to the 100 percent failure rate of late-stage clinical trials. What is the recipe for designing HFpEF trials with the best chance of success? There are several important considerations.
Social media has become increasingly important in the biopharma space as it not only allows emerging clinical-stage companies to efficiently increase their visibility online by posting interesting content, but it also provides a unique platform to engage with members of specific disease communities. Read how Diasome is learning about those issues that are most important to patients and healthcare providers by compiling this data and analyzing online conversations.
How many of us drive to work every day? How many of us know the route so instinctively that we no longer think about where we have to go? It’s easy, right?
The benefits of offering a mobile experience are simply too great to ignore.
Read how integrating CDISC standards at the very beginning of a clinical trial, research organizations can leverage powerful analysis tools to cut through much of the tedious, time consuming, and expensive manual work typically associated with collecting, cleaning, analyzing, quality controlling, and reporting clinical study data.
This white paper focuses on defining and expanding the definition of study startup, an element of clinical trials that is gaining attention because it offers the greatest opportunity to improve quality while compressing clinical trial timelines.
Dr. El Mustapha Bahassi, Associate Director of Clinical Laboratories at Medpace gives an overview of Central laboratories and the evolving world of immuno-oncology as well as current immuno-oncology biomarkers and detection methods.
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.
In order to increase the number of potentially successful clinical development projects in the microbiome space, it will be important to recognize standard drug development principles and global drug or biologic development requirements.
Discover how Almac helped one pharmaceutical company streamline processes and remove risk from their multiple clinical trial applications while maintaining data integrity with One Unified Clinical Trial Supply Solution.
Clinical labeling of biological products, operating within ultra-low temperatures can present unique challenges. Read this case study to find out how one biotechnology company built an effective strategy to label temperature sensitive clinical trial material.
While the potential for advanced therapies to provide curative treatments to patients around the world is very exciting, the pricing strategies and reimbursement models to support this innovation are quite complicated. In this article, I’ll explore the cost vs. price paradigm, through a supply chain lens, highlighting hidden costs and their impact on reimbursement potential.
Due to the continuous growth in drug development costs, there has never been a greater need for new and innovative ways to support the clinical trial supply chain. Explore key trends that are pushing the innovation envelope.
What can you do during your study to maximize your chances of success when it comes time to submit?
Maintaining the cold chain is a challenge when handling biologics such as vaccines, particularly when the clinic is in a remote location. Learn more about how Fisher Bioservices developed a qualified cold chain solution to transport Ebola vaccines to Uganda.
Learn how to find and hire competent CRAs in this free collection of articles highlighting CRA turnover as well as how to spot fraudulent resumes and counterfeit degrees.
More Content CollectionsPatient-centricity is not just a buzzword. At Novo Nordisk, we recognize that if we want to develop innovative treatments for patients living with chronic diseases, it is essential to form meaningful partnerships in which our patients’ expertise, knowledge, and experience are included and put into action. It was this radical shift in thinking that led to the creation of the Novo Nordisk Disease Experience Expert Panel (DEEP), a network of patient experts and advocates. This shared commitment to forming a true partnership, where patients are routinely included and guide every part of our care delivery model, immediately resonated and took off. Since the program launched in 2015, it has grown from 15 members to more than 120 members from over 20 countries across multiple therapeutic areas — and we are still growing.
For a patient with a debilitating disease, such as pulmonary fibrosis (PF), moments of hope can be few and far between. Many of these patients search desperately for new therapies to improve their quality of life, or possibly cure their condition, sometimes outside of the approved treatments prescribed by their healthcare providers.
Social media has become increasingly important in the biopharma space as it not only allows emerging clinical-stage companies to efficiently increase their visibility online by posting interesting content, but it also provides a unique platform to engage with members of specific disease communities. Read how Diasome is learning about those issues that are most important to patients and healthcare providers by compiling this data and analyzing online conversations.
