09.15.21 – Liver disease requires a patient-centered approach to testing



“Within hours, our clinical operations must have been completely remote. Patients could not come to the site. Our team was unable to enter the clinic. But we had to keep our studies on track and continue to monitor patient safety, ”says Catherine Gregor, director of clinical research administration for the Vanderbilt-Ingram Cancer Center.

In the available white paper, learn how numerous publications have examined the impact of the COVID-19 pandemic both on the delivery of heart health care in general and on cardiometabolic research in particular.

Complexity increases in sterile injectables, driven by factors such as formulation and delivery. Reduce complexity and save time on the way to IND clearance and first human trials.

As COVID-19 emerged around the world, sponsors needed to respond quickly. Discover the added complexity of managing R&D during COVID-19 and the de-prioritization of other indications as resources were diverted to work on COVID-19 therapies.

When selecting an eRegulatory clinical trial solution, the tendency is to select the software platform with the most features. Learn more about a quick analysis of the five critical considerations when determining the best solution for your facility.

Cell therapy has gone beyond “science fiction” and become effective FDA-approved treatments for three key hematologic cancers. Hematologist Dr. Robert S. Negrin deepens the identification and understanding of central differentiators in clinical trials of cell therapy.

When planning a clinical trial, it is common for sponsors to overlook or underestimate the possibility of protocol amendments. The COVID-19 outbreak has shown the rigidities of much of the clinical trial industry. Find out how having a CRO that can stay focused on its agility and flexibility can minimize the impact of protocol changes on your trial.

If you’re like many emerging biotech and medical device small and medium companies looking to upgrade your technology, you know it’s time to move from your old Excel trackers or SharePoint systems to a new data management system. clinical trials (CTMS) which may evolve with your organization. . But what are the right steps to choosing and implementing the CTMS that best meets your organization’s needs? Here we will chart a path for your management and IT teams to ensure that your CTMS selection and implementation process runs smoothly and efficiently from start to finish.

This article is the first part of a series of articles aimed at helping the emerging biopharmaceutical (EBP) leader and his team members to better assess the value of a “partnered” approach to outsourcing across the business continuum. development and marketing and potential approaches to mapping the right solution for their organizational needs.

A sponsor needed to provide data so that a non-compliance decision could be made at a major internal meeting that could not be rescheduled. The problems stemmed, in part, from a lack of communication between a large, somewhat impersonal CRO and a small sponsor who was used to close personal relationships and more or less constant interaction with the team managing their studies. We resumed the project in March 2013 and completed the data lockdown at the end of September.

In 2010, the MJFF initiated a large-scale clinical study conducted in a network of clinical sites around the world focused on the identification and validation of biomarkers for Parkinson’s disease. The study realized that a new way was needed to ensure that participants remained engaged throughout the long protocol and that the experience was as smooth as possible for volunteers and site coordinators. They were able to find a solution to support patient referral, as well as the effectiveness of the study site.

Tune in to the webinar below, where Vice President of Catalyst flex Growth Strategy, Betsy Brown, and Kathy Bradrick, Senior Vice President of Resourcing Operations, chat with guest speaker Maggie Neptune on key staffing strategies outsourced necessary for biopharmacy and mid-level life sciences. companies to be successful in their education before, during and after the pandemic while obtaining a sponsor’s perspective on the benefits of a flexible resource model.

In this webinar, we will explore how to manage a supply chain through Interactive Response Technology (IRT) with self-service tools and actionable insights as well as best practices for supply forecasting and management. excess stocks.

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