Newsletter | February 19, 2020

02.19.20 -- A Small Biopharma That Doesn't Use CROs

Featured Editorial
A Small Biopharma That Doesn't Use CROs
By Ed Miseta, chief editor, Clinical Leader

When it comes to conducting clinical trials, most emerging companies choose to access external resources through partnering with CROs. Martin Lehr, CEO of Context Therapeutics, does not use CROs, preferring instead to take part in investigator-sponsored trials (ISTs).

Industry Insights
Making Clinical Trials More Effective By Keeping Focus On The Patient
Q&A | A Q&A with Justin Schroeder, PCI Clinical Services

The need for clinical trials to meet the requirements of regulators, deliver high-quality data, and come in on budget has led to study designs that focus on timeliness and convenience, yet may unduly burden and inconvenience patients. Today, priorities are changing as sponsors realize studies designed around the needs of patients also result in benefits to other stakeholders. This has led to the rise of patient-centric clinical trials.

Re-Imagining Integration For Quality Clinical Trials
Article | By Chris Dailey and Chris Driver, Cenduit LLC

A clinical trial is a complex ecosystem that includes systems, processes, internal and external stakeholders, and technology providers. Integrating these vital elements into a cohesive whole can be the key to a trial’s success. Following are some tips to improve your eClinical strategy.

Machine Learning In The eTMF: Human-Aided Active Learning Processes
Article | By Jay Smith, TransPerfect

In a perfect world, machine learning technology could be used to collect, classify, verify, and archive the bulk of the documentation collected during the trial. Although there are time savings and quality advantages, artificial intelligence and machine learning, as they apply to clinical processes, and particularly the trial master file, have yet to overcome some real obstacles.

Can Integrated Service Providers Help Simplify Complex Clinical Trial Logistics?
Article | By Kate Hammeke, ISR Reports

Various factors are causing the distribution of clinical trial materials to become more complex, and sponsors looking to engage a third-party logistics provider have multiple options, each with benefits and drawbacks. Data from Industry Standard Research’s Clinical Logistics Market Dynamics and Service Provider Benchmarking report will educate readers about current usage patterns and preferences for outsourced clinical logistics providers as well as what the future may bring.

6 Early-Phase Dose-Finding Trial Designs For Oncology Therapeutics
Article | Premier Research

The optimal dose-finding strategy for a given therapeutic agent and indication is based on a multitude of factors, accentuating the need for individual tailoring in oncology drug trial design. Read on for a look at six of the most common dose-finding trial designs in oncology today.

Informed Consent: 6 Approaches To Increase Clinical Trials Participant Comprehension
White Paper | Advarra

Ensuring participants have appropriate knowledge of a study is a crucial goal of the informed consent process. This paper describes six research-based approaches for improving informed consent and supporting participants’ understanding of the studies they are asked to join.

Medical University Finds Solution To Track Participant Remuneration
Case Study | Greenphire

Concern ensued across the Medical University of South Carolina (MUSC) research faculty and staff when they received notice that departments would need to somehow track and sum all their petty cash, Walmart and Target gift cards, VISA cards, and checks issued through accounts payable (as there was no institutional research policy standardizing a single type of remuneration payment for clinical research participants). A fellow academic medical school recommended ClinCard by Greenphire, which ended up being the perfect solution.

Oracle Health Sciences Safety Cloud
Infographic | Oracle Health Sciences

The Oracle Health Sciences Safety Cloud offers the industry’s broadest platform of integrated systems and workflows to drive greater compliance and data insight while reducing cost.

WHO 2030 Framework For Efficient, Effective Regulation
Podcast | DIA

Dr. Petra Doerr, deputy executive director of Swissmedic, and Dr. Murray Lumpkin, deputy director of regulatory affairs and lead for global regulatory systems initiatives for the Bill and Melinda Gates Foundation, explain the World Health Organization’s “Essential Medicines and Health Products Strategic Framework” for 2016 to 2030.

DIA 2020 Global Annual Meeting

June 14 to 18, 2020 | Washington, DC

Life Science Training Courses
An Introduction To Good Laboratory Practices (GLP)
February 20, 2020 | 1:00 PM EST
Change Management Plan Development For Risk-Based Clinical Studies: From Site Monitoring To Vendor Management And Beyond
February 21, 2020 | 1:00 PM EST
Clinical Quality Management Systems (QMS): Establishing A Practical & Compliant Program
March 4, 2020 | 1:00 PM EST
21 CFR Part 11: Understanding The ERES Regulation For Compliance Success
March 5, 2020 | 1:00 PM EST
Responding To Clinical Observations: Developing Robust Audit & Inspection CAPAs
March 10, 2020 | 1:00 PM EDT
Regulatory GCP Inspections: Preparation, Participation & Follow-Up
March 12, 2020 | 1:00 PM EDT
Regulated Clinical Documentation And Content – Purpose, Proper Handling, And Metadata
March 18, 2020 | 1:00 PM EDT
FDA REMS Inspection Guide: Audit Preparedness Best Practices
March 25, 2020 | 1:00 PM EDT
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