Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 3,100 people across 36 countries.
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.
In this webinar, medical experts from Medpace’s Infectious Diseases and Hematology/Oncology teams discuss infectious diseases in the immunocompromised host—with a focus on hematologic malignancies and hematopoietic cell transplantation patients—and the unique challenges for clinical development.
In this presentation, Medpace medical and operational experts discuss the trial design challenges for specific oncology populations and how to overcome them.
Lyon Gleich MD, and Jennifer L. Cutter PhD, engage in an interactive discussion on the topic of immuno-oncology and the unique challenges and considerations for managing clinical research.
In this presentation, Medpace Medical Device experts discuss key considerations for generating real-world evidence and how to apply critical insights in order to drive late-stage clinical research.
Pharmacoeconomic assessment of a drug, medical device, or other healthcare product can take on many forms and occur at multiple points in the development cycle. Cost-effectiveness analysis, a major component of pharmacoeconomic assessment, has traditionally occurred in the later phases of product development—either as a piggy-back to a phase III or pivotal clinical trial, or peri-authorization. Join Medpace experts as they explore the application of pharmacoeconomic assessment throughout all phases of clinical trials as well as in observational studies, including registries and other post-marketing data collection.
Planning and executing a clinical study for an orphan indication presents a unique set of challenges and considerations. In this webinar, Michelle Petersen, Medpace Clinical Trial Manager discusses successful strategies and best practices for addressing some of these including: unique methods to site selection and feasibility, successful recruitment/retention approaches, overview of common study execution needs, and optimal training and monitoring strategies.
The momentum and muscle behind "finding the right drug for the right patient at the right dose" has further escalated with President Barack Obama’s announcement of a $215 million dollar Precision Medicine Initiative. In this webinar, Dr. Frank Smith will explore advances in precision medicine and how it is affecting clinical research. As a pediatric hematologist/oncologist, he will use his extensive clinical and research background as a backdrop for the discussion.
In CNS drug development, more and more diseases once viewed as common are now known to be collections of rare variants. Our deepening understanding of the human genome and pathophysiology has led to fragmented classifications of common neurological or psychiatric disorders based on identified genetic markers.
In this webinar, Medpace discusses how patient-focused clinical trial design and collaborative approaches to site enrollment can accelerate clinical research. This presentation features a doctor from Cincinnati Children's Hospital Medical Center and a parent of a child with Duchenne muscular dystrophy.
In this webinar, medical and operations experts from Medpace facilitate a Q&A session with Dr. Stephen A. Harrison, an experienced Key Opinion Leader (KOL) in NASH. The presenters participate in an in-depth discussion on selected topics associated with NASH development as well as strategies and opportunities for researchers.
In this webinar, experts from Medpace and Diversigen engage in an interactive discussion on the possibilities as well as the challenges in clinical research and development involving the human microbiome.
With an established regulatory environment and a strong healthcare infrastructure, Latin America continues to grow as an advantageous landscape for conducting clinical research. Join Medpace experts Anibal Calmaggi, MD, Senior Medical Director, Infectious Diseases and Vaccines, and Wanda Dobrzanski, MD, Director Clinical Operations, Pediatric infectious diseases and Pharmaceutical medicine specialist, as they share their collective 36 years of experience in designing and managing clinical research in Latin America.
New trends are emerging in medical device development. In this webinar, Dr. Dean J. Kereiakes, a leading Key Opinion Leader in interventional cardiology, shares his expert views on how the cardiovascular medical device world is evolving, and how this field links to daily clinical practice and research. Through panel discussion with Dr. Nicholas Alp and Danny Detiege and through audience interaction, he provides valuable insights into the future of medical device clinical development.
In this webinar, we explore four areas that can dramatically affect the cost and timelines of your clinical program and offer insight into elimination and control of these hidden landmines.
Gene editing technology is a rapidly evolving area of clinical and translational research that combines the potential of great advances with profound ethical challenges. Join Medpace medical and regulatory experts to discuss the unique opportunity of this evolving technology as it applies to human diseases.
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Dr. Sharmila Majumdar, PhD, Professor and Vice-Chair of Research in The Department of Radiology and Biomedical Imaging at University of California San Francisco shares her thoughts with us about imaging in rheumatoid arthritis. She addresses the differences between Osteoarthritis and Rheumatoid Arthritis and how they influence the type of imaging we should use, the best imaging modality for RA diagnosis or progression of disease as well as the future for imaging in clinical trials for RA therapeutics.
Mustafa Bashir, Associate Professor of Radiology and Medicine in the Gastroenterology Division at Duke University School of Medicine, discusses his experience with imaging biomarkers for use in clinical trials for Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic SteatoHepatitis (NASH).
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.
Traditionally hard-to-treat neurological diseases – including Alzheimer’s and Parkinson’s – which were once considered to be common, are being reclassified as a collection of rare diseases based on genetic markers. This article shares new strategies for enrolling patients and outlines the challenge of measuring the efficacy of the experimental treatment and determining whether it’s producing the desired effect.
For clinical trials of rare diseases, challenges such as recruiting patients, staying within timelines and handling the inevitable trial amendments can be amplified since the eligible patient population is so limited. This article highlights recent changes that are benefitting rare disease trials including multi-center trials, regulatory bodies establishing programs aimed at incentivizing rare disease drug development and smaller requirements for the number of patients in which a therapy must be tested before it can be considered for approval.
Ophthalmology is a growing therapeutic area in clinical research with new and exciting developments occurring in the field, particularly in stem cell and gene cell therapies. Marco Tangelder, MD, Senior Medical Director, Medical department at Medpace highlights some of the advancements in Ophthalmology research and where the field is headed.
Nothing derails a clinical study timeline more than poor planning and not anticipating and preparing for the potential roadblocks. While you may not be able to anticipate everything, many of the risks and challenges outlined in this article can in fact be averted if you understand the landscape and prepare accordingly.
Dr. Franklin Smith, Medpace’s vice president of medical affairs and specialist in hematology oncology, reflects on advances in oncology drug development.
The objective of this study was to develop and support a process for assessing the comparability of data used in global clinical trials from four individual laboratories, wholly owned by the same central laboratory entity, and that the same tests on the same samples are under statistical control and acceptable limits of variation.
Clinical oncology trials are more complex and time consuming than those in any other therapeutic area and failure rates are frustratingly high. Given the urgent need for new oncologic therapies, sponsors are eager to find more effective ways to conduct clinical research.
With the existence of new tools from cross disciplinary teams - applying innovation in study design, use of patient registries, and partnering with patient advocacy groups - the work for effective therapies continues.
An evaluation of the effect of hemolysis, icterus and lipemia on chemistry assays and further assessment of the association between the amount of interfering substances and ordinal values reported by the automated chemistry analyzer as H-, I- and L-indices.
Research in diagnosis, management, and therapy development, as well as development of standardized guidelines for upcoming studies need to be addressed in order to improve the prognosis of DFI patients.
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.
A CRO with deep therapeutic, regulatory and operational expertise facilitates the risk-assessment process by highlighting items within the protocol design that have the potential to impact overall risk levels. Identifying these risks and potential operational challenges early in the process is essential to the success of RBM later in the study.
Revised study now includes the opportunity to demonstrate the cardiac safety of a new drug by utilizing Exposure-QT response study data in dose escalation and other studies.
Obstacles still remain in developing effective and efficient new targeted therapy agents, identifying the biomarker tests that indicate which patients will be responsive to them, and implementing them in clinical practice.
Understanding the non-invasive methods for assessing ﬁbrosis range from biomarker assays to advanced imaging techniques such as transient elastography.
Applying ‘lessons learned’, innovative thinking, and creative problem solving to overcome unique challenges associated with conducting these studies.
This white paper explains the role of study design in RWE, key data sources for RWE-based approaches, and some unique considerations for RWE studies.
How enhanced state-of-the-art flow cytometry capabilities empower flexible approaches to global clinical trials across multiple therapeutic areas.