Insights On Partnering
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Bioteching With Vicky Hsu
5/10/2022
Vicky Hsu, SVP Greater China Region and Head of Biotech Operations APAC, shares how her father’s spirit and determination in facing cancer led her to pursue a career in healthcare.
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Navigating Complexities In Global Payment Operations: Best Practices For Sponsors
12/7/2020
Deploying a successful global program for paying clinical research sites is an achievable and worthwhile goal but requires an understanding of the differences in frameworks and motivations. Learn what is needed to pays site globally in a reliable, timely, and equitable manner.
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Clinical Supply Agility: Expect The Unexpected
1/20/2022
This webinar brings together a panel of supply chain experts to bring insight into managing the uncertainty and risk that comes along with clinical supply decisions.
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Tumor-Agnostic Treatments: A Game Changer For Rare Oncology Trials
11/19/2020
There has been a tremendous leap forward in the understanding of the molecular characteristics of tumors— not only in targeted therapies but also in the development of tumor-or tissue-agnostic treatments. In this blog post the changing rare oncology landscape and novel approaches to rare cancer trials are explored.
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Collaborating Effectively To Transform Clinical Trials
12/15/2020
Review the latest industry direction and technology trends in connecting sponsors, CROs, and sites to accelerate clinical research.
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A Successful Approach To Quality Oversight Visits
5/24/2021
Sponsors and CROs employ CRAs to monitor clinical study sites. Because most site monitoring is done in the field, it is challenging for study managers to know and understand if CRAs/monitors are conducting their duties effectively and efficiently. Many study sponsors therefore employ co-monitoring/oversight visits to directly evaluate CRA performance and facilitate training. The following process can help to achieve successful co-monitoring/oversight visits.
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Critical Steps For Writing An Impactful Clinical Audit Report
4/5/2022
Learn how an audit report should identify how quality and risk management are managed throughout the entirety of the study conduct.
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Planning The Way Forward In Neurodegenerative Disease Studies
7/14/2021
The recent FDA guidance entitled "Human Gene Therapy for Neurodegenerative Diseases" (ND) provides recommendations for Sponsors who are developing human gene therapy (GT) products for neurodegenerative diseases, which affect adult and pediatric patients. It focuses on considerations for product development, preclinical testing, clinical trial design and marketing approval pathways. This article outlines several areas to consider when preparing for regulatory agency interactions.
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Partnering Solutions For Emerging Biopharma
7/26/2021
This paper is the first part of a series of articles aimed at helping the EBP executive and his/her team members better assess the value of a “partnered” outsourcing approach across the continuum of development and commercialization, and potential approaches to mapping out the right fit for their organizational needs.
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Removing Clinical Trial Travel Logistics In The Height Of The COVID-19 Pandemic
11/9/2020
With the current clinical trial logistical challenges there comes the need for ingenuity – partnering with a travel provider who can navigate these difficult and uncertain times to ensure sustainability for the trial.