Newsletter | July 29, 2019

07.29.19 -- A Patient's Journey: Human Interactions Matter In Immunotherapy Trials

 
Featured Editorial
A Patient’s Journey: Human Interactions Matter In Immunotherapy Trials
 
By Ed Miseta, chief editor, Clinical Leader

Mary Elizabeth Williams is a journalist and an author. She is also a patient with metastatic melanoma who participated in a Phase 1 immunotherapy clinical trial. There is much that pharma can learn from her in terms of how companies approach clinical trials and drug development.

Industry Insights
Real-World Evidence: Explaining The Current State Of The FDA’s RWE Program
Article | By Paul Roma, Ciox Health - Life Sciences

This article will guide you through the FDA’s real-world evidence (RWE) program and what it means for drug developers. It also explains the potential real-world data offers in developing real-world evidence to significantly and safely accelerate the drug approval process.

Reimagining 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.

The Fully Automated eTMF: Delivering A Better Clinical Trial
Article | By Carl Dietz, Innovocommerce

An eTMF itself is not an automation solution for managing essential documents. Even if you assign users rights to upload, approve, or reject document versions, essential document workflow is still missing. Most eTMFs cannot track a document’s history, its edits, or any collaboration around each document. That leaves the entire essential document workflow in manual mode without an automation solution. Read how automation improves trial speed, CRA productivity, site satisfaction, and provides a perfect audit trail of documents on their way into the eTMF.

Importance Of Chain Of Custody Documentation For Biologics
Article | Thermo Fisher Scientific

Preventing patients from receiving “counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the U.S. Food and Drug Administration (FDA). Chain of custody for genetic and cell therapies differs and is more complex than that for traditional pharmaceuticals, and the requirements for documentation vary as well.

A Better Way To Pay Clinical Research Sites: Automating Site Grant Payments
White Paper | Greenphire

How automating site grant payments can optimize payment processes for sites leading to greater site satisfaction and allowing sites to operate at peak performance and reduce errors.

Oncology Clinical Trials RFP Planning Guide
E-Book | IQVIA Biotech

Our RFP planning guide is a must-have for oncology sponsors. Identify key cost drivers, save time, and make planning easier. IQVIA Biotech developed this guide to help emerging oncology sponsors navigate clinical outsourcing with timeline and financial considerations in mind.

Seeking Out Clinical Trial Costs And Eliminating Them With Technology
Webinar | Medrio

Costs and complexity are rising in clinical trials. But innovators are responding with potentially game-changing new approaches to address these challenges. In this webinar, Medrio CEO Mike Novotny explores this crucial issue.

Sponsor
  Clinical Trial Supply Southeast 2019
 

October 2 and 3, 2019 | Durham, NC

CTS Southeast will return to North Carolina in 2019 to look at ongoing regulations, enhancing the supply chain, and making sure the right systems are in place. Top trial sponsors and regulatory bodies such as GSK, G1 Therapeutics, PRA Health Sciences, GS1, and many more came together to share their insights into achieving a compliant and error-free supply chain.

Life Science Leader Magazine
 

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