Newsletter | June 10, 2019

06.10.19 -- AI And Blockchain Will Take Center Stage At DIA 2019


The best technology succeeds in the background. Introducing Signant Health (formerly CRF Bracket), and the industry’s most comprehensive patient-centric suite for clinical research. Uniting eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies, and Endpoint Quality, Signant makes it easier to participate in — and sites and study teams to run — clinical trials. Take a significant step toward patient-centricity at

Featured Editorial
AI And Blockchain Will Take Center Stage At DIA 2019
A Q&A with Sudip Parikh, Ph.D., senior VP and managing director, DIA Americas

Clinical Leader spoke to Sudip Parikh, senior VP and managing director, DIA Americas, to discuss the 2019 event, the keynote speaker, technology sessions, real-world evidence, and patient-centricity. In this Q&A, Parikh highlights some of the themes of the 2019 meeting and sessions that attendees will not want to miss.

4 Key Ingredients Of A Robust Risk Management Framework
By Paola Murphy, Megan Brickley, and Sheila Gwizdak, Halloran Consulting Group

It is certainly no surprise that risk management continues to hold the spotlight as a hot topic within the biotechnology/pharmaceutical industry. With the increased focus by regulatory authorities on an organization’s ability to identify, mitigate, and control risks, the industry remains in a state of growth, developing and evolving practices to ensure proper alignment with industry best practices and regulators’ expectations. Many organizations are finding it difficult to establish and embed risk management practices, as doing so requires a paradigm shift from a traditional risk-averse industry culture.

Industry Insights
ICH E6 R2 – Best Practices For Implementing A More Formal Risk Management Process
Article | By Dr. Volker Hack and Brian Barnes, PPD, PPD

ICH E6 R2, which was published in November 2016, requires clinical trial teams to implement a more robust risk management process before starting clinical trial activities. The idea is to undertake a well-balanced approach between applying critical thinking and implementing lessons learned. While there may be some change management challenges to overcome and extra time and resources to be assigned, read how the benefits of a robust risk management process designed to improve subject safety and data integrity clearly outweigh any perceived additional efforts.

Six Trends Shaping Tomorrow's Clinical Trials
Article | By Jitendra Kumar, Thermo Fisher Scientific

Due to the continuous growth in drug development costs, there has never been a greater need for new and innovative ways to support the clinical trial supply chain. Explore key trends that are pushing the innovation envelope.

The Essential Role Of Interactive Response Technology (IRT) In Clinical Trial Supply
Article | By Dave Holly and Eddie Montoya, Sharp Clinical Services

IRT professionals can bring together supply chain and clinical team staff for discussions on actual trial needs. Learn how including IRT professionals earlier in the planning phase of clinical trials may result in a better understanding of supply chain needs. This can increase the efficiency of inventory management and lead to unforeseen cost savings over the course of the trial.

Ask The IRB Experts
Article | By Dr. Lindsay McNair, MD, MPH, MSB, WCG

Clinical research is complicated. At WCG, we frequently get questions about the ethical conduct of research from clinical team members at biopharma companies and study sites. We know that for many of the questions we get, the person asking is not the only one struggling with that issue. Read the questions your peers are asking – and if you don’t see yours, submit one of your own.

Applying Biomarker Driven Strategies In Drug Development
Article | Cytel

Determining appropriate stratifications and relevant clinical endpoints for specific sub-populations can be challenging. Therefore, it is necessary for development strategies to incorporate explorations and determinations of suitable biomarkers early in the development of a new therapy.

Improving Patient Recruitment Rates In Oncology Trials
White Paper | Syneos Health

The percentage of oncology patients participating in clinical trials is remarkably low: 8.1 percent according to a recent meta-analysis. Read a new report from Syneos Health that shares how enrollment rates and study timelines can be vastly improved by understanding the patient pathway and working to meet patients where they are as they travel along it. The report shares actionable insights for how to meet patients at the right point in their journey – from understanding the influence of emotional pathways of the patient to selecting and priming sites.

eCOA Provider Collaborates With Hospital To Create Electronic Version Of The Neurostatus-EDSS
Case Study | Signant Health, formerly CRF Bracket

Examine how the electronic Neurostatus-EDSS replaces the way data is captured in the traditional assessment that requires EDSS raters to complete paper forms that suffer from all the typical issues with inter- and intra-rater reliability.

How A Top CRO Used ClinCard To Create A Personalized Patient Experience For A Non-interventional Psoriasis Study
Case Study | Greenphire

The CRO realized that it needed to introduce new ways to keep participants engaged and interested if it was going to successfully support this trial. The CRO identified ClinCard as the ideal software that could instantly get study participants their stipends, without adding a burden on the site staff.

MID-NET Among PMDA’s First Steps Into RWE
Podcast | DIA

Dr. Yoshiaki Uyama, director of the Office of Medical Informatics & Epidemiology for the Pharmaceuticals and Medical Devices Agency (PMDA), Japan, and DIA Global Forum Regulatory Science co-editor, shares his vision for utilizing real-world evidence in regulatory science.

Estimands: Not Just A Statistical Issue

Tuesday, June 25, 2019 | 10:00 a.m. EDT

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