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.
Don’t assume your clinical trial will survive endless change orders, extended deadlines, cost overruns, and missed objectives. Recognizing early warning signs that your trial is in trouble, and taking quick decisive action, can often get studies back on track. Improving operations can solve most failure risk factors, thus increasing the odds of success.
The longer you addressing a faltering clinical trial, the greater the risk your trial progresses from faltering to failure. And the deeper a trial's problems, the more likely you'll have to ask for a substantial budget increase—another difficult conversation. Here are some tips to act quickly for the best ROI.
Small and emerging biopharma companies are conducting almost 50% of the clinical trials in the United States today. Unlike “big pharma”, small companies are usually working with lean teams, limited resources, and minimal infrastructure. In this paper, we explore some of the unique challenges for clinical development teams, and solutions that can reduce the pressure on teams and timelines.
After years of innovative research, advanced therapies are dramatically changing the way patients are treated for a wide variety of diseases – particularly for patients with rare diseases and orphan indications. In this webinar join experts from Medpace’s medical, regulatory and operational team with hands-on experience in rare disease and ATMP development as they explore scientific advancements the regulatory landscape and lessons-learned and best practices for operationalizing rare disease clinical trials including identifying, enrolling and retaining patients, as well as special considerations for ATMPs.
UBC’s Natalie O’Donnell, Executive Director, SERRM, provides a Risk Evaluation and Mitigation Strategy (REMS) overview. Learn more about the importance in partnering with an experienced REMS team for your next study.
Some unique CAR T cell therapies have already been approved by the US Food and Drug Administration (FDA) and are the first steps toward further groundbreaking science. In this webinar, Emile Youssef, Premier Research’s Executive Medical Director, reviews the operational and clinical pathways that are helping to bring these technologies to patients.
Dr. Annette Stemhagen, SVP & Chief Scientific Officer, speaks to Pregnancy Exposure Registries (PERs) and why partnering with an experienced team is so vital.
Investigator Initiated Studies (IIS) offer pharmaceutical sponsor companies the benefit of increasing product knowledge and expanding the medical use of their drug. However, managing these studies presents unique clinical supply chain challenges and can become a very complex process. In this webinar, Almac’s clinical supply experts address these challenges and provide insight into how to best manage investigator initiated clinical studies.
Sponsors, CROs and sites around the world partner with Greenphire to enable a secure and compliant electronic payment technology that makes their lives easier and removes the barriers to successful recruitment and retention. Watch this video to see how it works!
UBC has focused on drug safety evaluation with RWD for more than 15 years and is aligned with FDA’s Sentinel Initiative. UBC’s safety scientists and epidemiologists provide comprehensive and customized RWD solutions to evaluate the safety of your marketed products.
Implementing an enterprise-wide Real World Evidence strategy is essential to meet the growing demands of regulators, patients, healthcare providers and payers to support approval, treatment decisions and reimbursement. Fluency in evidence-generation combined with operational expertise in RWE are crucial for capitalizing on the potential RWE has to offer.
Regulator and payer constituencies have recognized the immense potential of real world evidence (RWE) in accelerating our ability to answer important questions about the safety and effectiveness of medical treatments. The opportunity to capitalize on RWD/RWE goes beyond the regulatory domain. Payer demand for evidence to support a product’s value proposition is growing, in part due to proliferation of value-based reimbursement models. In addition, the 21st Century Cures Act mandates that FDA explore the use of RWE to expand indications for approved drugs and to fulfill post approval requirements.