Cross-sectional studies (CSS) serve as an effective study design option to gather pertinent epidemiological data quickly to support drug development across the lifecycle. Here we explore how a hybrid MCR combined CSS can be an advantageous study design for real world evidence (RWE) generation, and how gaining a better understanding of the implementation of these designs can allow for better future planning, as well as to guide the development of the next generation of real world studies.
Biosimilars are generally expected to offer a competitive price advantage to appeal to healthcare organizations and payers which make them an attractive business opportunity.. This whitepaper provides an introduction into key regulatory and development concerns for sponsors, including a discussion of the factors that affect biosimilar uptake for the United States and Europe and recommendations to address these issues
Midlantic Urology Associates had been employing a single driver for all participant pick-ups. This proved to be inefficient and unsustainable, so they began utilizing taxis. This alternative was costly and unreliable – there had to be a better way. ClinCard’s integration with Lyft has not only improved the experience for patients and study coordinators but has also helped with recruitment as new patients are enrolling in the study as a result of this added convenience.
Sadly, the average drop-out rate across clinical trials is 30%. Greenphire has increasingly seen clients focused on increasing completion rates of patient reported outcomes and bolstering compliance using ClinCard. ClinCard has built-in text reminders for upcoming onsite patient visits and the ability to trigger “micropayments” when select tasks are completed.
Learn how IQVIA Biotech helped a biotechnology company reach critical milestones as it prepared to launch an international Phase III clinical trial for its investigational ALK inhibitor in patients with non-small cell lung cancer.
Advancements in science and technology are driving accelerated timelines and creative pathways for oncology drug development. Oncology sponsors and regulators seek new ways to efficiently move promising therapies from the clinic to approval – embracing a streamlined path that bypasses the traditional development paradigm of standalone sequential Phase I/II/III trials.
The promises of patient engagement technologies are big, but can they be kept? In this webinar experts share the most common questions asked by study teams and discuss how to address them.
Watch this webcast to learn how artificial intelligence, natural language processing, and machine learning are poised to change the way we do pharmacovigilance.
For years, this laborious step has ranked as the lengthiest of study startup activities, and recent data suggest it remains the primary cause of site activation failure. This webcast will cover How granular metrics empower business intelligence, process optimization and efficient resource allocation and other steps to help avoid bottlenecks and delays.
While risk management efforts in drug development have focused mostly on post-marketing drug safety, the clinical trials process has its own mix of potential risks waiting to derail a company's multimillion-dollar development programs. For study startup, a problematic area of clinical trials, these risks include site selection and patient enrollment issues, budget and contracting delays, logistical problems with timely drug shipments, and regulatory hurdles.
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.
Virtual study designs are transforming the way biopharmaceutical businesses conduct research. Tactics that decentralize the approach to clinical and observational research are ushering in a new paradigm of efficient data collection and patient centric engagement.
Getting participants to and from a research site can be burdensome for the site staff, study coordinators, participants, and their families and/or caregivers. Greenphire has designed the most comprehensive travel solution built to meet the retention goals of global clinical research.
Veeva Vault Study Startup accelerates time to site activation by connecting global teams and enabling best practices for managing country and site start-up processes. Document-intensive start-up processes and milestone maintenance activities are managed in a single system, providing unparalleled insight and efficiency. And because Veeva Vault Study Startup works with Veeva Vault eTMF within the Veeva Vault Clinical Suite, study start-up and TMF content and data are seamlessly accessed across teams, systems, and studies.
Veeva Vault Study Startup speeds clinical trials by bringing together study start-up activities and processes in a single, easy-to-use application. Part of a unified suite of clinical operations applications, Vault Study Startup enables seamless sharing of information and documents across CTMS, eTMF, and study start-up processes, improving collaboration and increasing efficiency.