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.
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.
This paper is intended as a discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.
Clinical supply chain planning is imperative, as it allows you to develop a strategy and best practices for quickly and efficiently delivering goods to support all the needs of the trial. But, where do you begin?
Preventing patients from receiving “counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the US Food and Drug Administration (FDA). Chain of custody for genetic and cell therapies differs and is more complex than for traditional pharmaceuticals, and the requirements for documentation vary as well.
A common issue regarding “faltering” studies – studies that are not satisfying their time, cost, and quality parameters – is poor recruitment. Recruitment issues can delay deadlines and jeopardize the drug’s ultimate approval, if left unresolved. If your study is struggling because of recruitment issues, here are some considerations that can be used to rescue your clinical trial.
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.
With the new EU clinical trial registry portal expected to launch next year, it’s imperative that sponsors – particularly small and mid-size organizations – understand the complexities of EU disclosure. Thomas Wicks, an expert in clinical trial disclosure, and Karen Rutkowski, an expert in medical writing, share actionable insights on compliance.
Global clinical trial disclosure compliance is inherently complex, with over 39 registries, Most sponsors simply lack visibility into all the places they need to disclose information or what their commitments are. Automation can help make global compliance easier.
Today’s healthcare industry is hyper-focused on patient engagement. With plain-language summaries (PLS), clinical trial sponsors can make patient engagement more than a mantra. In this video, learn PLS best practices from two expert authorities.
Dr. Annette Stemhagen, SVP & Chief Scientific Officer, speaks to the differences between Interventional and Observational Studies.
Your own dedicated project management team
For more than 25 years, Bellwyck has been a true partner in developing smarter solutions for the pharmaceutical industry — from clinical trial to commercialization. Our consulting services start with a dedicated project management team led by a single point of contact throughout your project.
Cold-chain logistics expertise
Our GMP-compliant storage capacity, cold-chain logistics expertise and global distribution capabilities means we can fulfill your unique needs no matter the size or scope of your project.
While regulatory compliance is a major driver for serialization projects, breaches to the Pharmaceutical Supply Chain distribution system are also a concern, as they can pose health risks to patients and financial risks to the supply chain stakeholders. At Bellwyck, our holistic and comprehensive approach to serialization ensures these risks will be mitigated and will maximize your value.