Newsletter | September 15, 2021

09.15.21 -- Liver Disease Requires A Patient-Centric Approach To Trials

Featured Editorial
Industry Insights
Remote Connectivity Is Now A Requirement In The Site, Sponsor, And CRO Relationship

“Within hours, our clinical operations had to be fully remote. Patients couldn’t come on site. Our team couldn’t get into the clinic. But we had to keep our studies on track and needed to continue to monitor patient safety,” says Catherine Gregor, director of clinical research administration for Vanderbilt-Ingram Cancer Center.

Looking Beyond The Light At The End Of The Tunnel

In the available white paper, read how numerous publications have examined the impact of the COVID-19 pandemic on both cardiac healthcare delivery in general and cardiometabolic research in particular.

10 Reasons Formulation Complexity Is On The Rise In Steriles

Complexity is rising in sterile injectables, driven by factors that include formulation and delivery. Reduce complexity and save time on the way to IND authorization and first-in-human trials.

AI And Advanced Analytics: Delivering Value For Clinical Trials During COVID-19

As COVID-19 emerged around the globe, sponsors had to react quickly. Read about the added complexity of managing R&D during COVID-19, and the deprioritization of other indications while resources were diverted to work on COVID-19 therapies.

Top 5 Requirements To Consider For An eRegulatory Clinical Trial Solution

When selecting an eRegulatory clinical trial solution, the tendency is to select the software platform with the most features. Read more about a quick breakdown of the five critical considerations when identifying the best solution for your institution.

Identifying And Understanding Differentiators In CAR T-Cell Therapy

Cell therapy has moved beyond “science fiction” and into effective FDA-approved treatments for three key hematological cancers. Hematologist Dr. Robert S. Negrin takes a deeper dive into identifying and understanding the central differentiators in cell therapy clinical trials.

How To Cut The Negative Impact Of Protocol Amendments

When planning a clinical trial, it’s common for sponsors to overlook or underestimate the possibility of protocol amendments. The COVID-19 outbreak has shown the inflexibilities of much of the clinical trials industry. Read how having a CRO that can remain focused on being agile and flexible can minimize the impact of protocol amendments on your trial.

How To Choose And Implement A CTMS

If you are like many emerging small to midsize biotech and medical device companies looking at upgrading your technology, you know it’s time to move from your old Excel trackers or SharePoint systems to a new clinical trial management system (CTMS) that can grow with your organization. But what are the right steps toward choosing and implementing the CTMS that best meets your organization’s needs? Here, we’ll lay out a path for your management and IT teams to ensure your CTMS selection and implementation process runs smoothly and efficiently from start to finish.

Partnering Solutions For Emerging Biopharma

This paper is the first part of a series of articles aimed at helping the emerging biopharma (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.

Cleaning Up Patient Data … Quickly
A sponsor needed to deliver data so that a go-/no-go decision could be made at a major internal meeting that couldn’t be rescheduled. The problems stemmed, in part, from a failure to communicate between a large, somewhat impersonal CRO and a small sponsor that was used to close personal relationships and more or less constant interaction with the team managing its studies. We picked up the project in March 2013 and completed data lock by the end of September.
The Michael J. Fox Foundation (MJFF) For Parkinson’s Research Works With Service Provider To Remove Reimbursement And Travel Obstacles For Clinical Study Participants

In 2010, the MJFF launched a large-scale clinical study conducted at a network of clinical sites around the world focused on identifying and validating Parkinson’s disease biomarkers. The study realized it needed a new way to ensure that participants were remaining engaged throughout the long protocol and that the experience was as seamless as possible for both the volunteers and the site coordinators. They were able to source a solution to support patient-centricity, as well as study site efficiency.

Accelerating Clinical Studies While Reducing Operational Cost

Tune in to the below webinar, where vice president, Catalyst flex growth strategy, Betsy Brown, and senior vice president, resourcing operations, Kathy Bradrick, discuss with guest speaker Maggie Neptune the key outsourced staffing strategies needed by mid-tier biopharma and life sciences companies to achieve study success before, during, and in the wake of the pandemic while gaining a sponsor’s perspective on the benefits of a flexible resourcing model.

Tips For Overcoming Today's Drug Supply Challenges Through Technology

In this webinar we will be exploring 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 overstock management.


Virtual Event | October 13, 2021, 9:50 a.m. – October 14, 2021, 5:15 p.m.

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