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.
That’s a wrap on our second DIA global annual meeting workshop, “Setting the Stage for Stakeholder Collaboration.” Everyones engagement turns an idea into real moment of reflection and learning for all. Read more about these collaboration scenerios and what was learned from them.
Now more than ever, especially in rare disease populations, and as manufacturers look to add many different types of data from a variety of sources. Challenges exist when data with differing data elements from a number of sources (EDC, registries, claims, HCPs, pharmacy, lab, etc.) converge. Therefore, standardization of the data is paramount in generating evidence to benefit patients, especially rare disease patients, where population size is limited.
Take a closer look at funding strategies for companies launching products for the first time. Does partnering or "Going it Alone" make more sense for emerging companies? Read the findings of a 2006-2015 analysis, including implications for research companies, their potential large pharma commercialization partners, and venture capitalists.
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.
In an increasingly complex drug development and healthcare environment, it is extremely important for companies to be able to demonstrate value, even if their intention is to be acquired or to out-license their asset following proof-of-concept. Learn more about partnering solutions available to small and emerging biotech companies.
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.
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.
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.
Almac Adapt is a Just In Time Manufacturing solution which puts patients first and provides sponsors with a unique, adaptive supply strategy to ultimately meet the expanding challenges of clinical trials.
As your clinical material partner, we simplify – and accelerate – your clinical trials. From assistance with time-consuming international documentation through destruction following all regulatory protocols, RPS is your trusted clinical trial partner.