Authors


Anita Ramachandran

Latest:

The Future of Regulatory Intelligence With Conversational AI

Chatbots can benefit regulatory landscape in light of evolving standards and guidelines.


Ed Ikeguchi, MD

Latest:

Tackling Trial Diversity Through Higher Innovation Standards

Advancing responsible AI innovation to help resolve patient disparities.



Mike Hollan

Latest:

‘Hypothesis-Free’: Getting Proactive About Signal Detection

Elizabeth Smalley, director of product management, data, and analytics at ArisGlobal speaks about her work at the software company in supporting the efforts of life sciences clinical and pharmacovigilance teams in signal detection.


Karina M. Soto-Ruiz, MD

Latest:

Oversight Method Identifies Critical Errors Missed by Traditional Monitoring Approaches

Study Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.


Maurice Solomon

Latest:

Why Decentralized Clinical Trials Are the Way of the Future

Assessing the opportunities, considerations and implications of decentralized trials—and why they’re here to stay


Sanjay Bhardwaj

Latest:

The Future of SDTM Transformation: AI and HITL

Using an AI + Human in the Loop (HITL) approach can be utilized for Study Data Tabulation Model (SDTM) transformation, potentially alleviating current challenges



Jacqueline Dang

Latest:

How Sponsors Can Use Health Decision Science to Improve Clinical Trial Recruitment and Retention

Examining the behaviors of clinical trial stakeholders to better understand challenges in patient participation.


Avania

Latest:

The MDR: Navigating Europe’s New Standard for Medical Device Safety

Europe’s new Medical Devices Regulation (MDR) is four times longer than the previous Medical Device Directive, and it has raised the bar for clinical evaluations. It’s imperative that manufacturers proactively identify the gaps in their data and take the necessary steps to fill them — from pre-clinical through post-market. Many companies are unprepared for this task. Our guest, Dr. Kim van Noort, will walk us through some of the biggest challenges that MDR poses, and tell us how to overcome them.


Vyankatesh Manwade

Latest:

Future of Clinical Trial Documentation Management: eTMF Integrated with Blockchain

eTMF-blockchain technology offers a myriad of application benefits to data quality and integrity while ensuring compliance to ethical standards.



Vandita Tripathi

Latest:

Establishing Metrics and Standardization for Non-CRF Data in EDC

While Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.


Hilde Vanaken, Silvia Chia, Tina Caruana, Manuela Ghielli, Wendy Frye, Holly Robertson

Latest:

Navigating eConsent Submissions: Who, What, Where, and Why?

Unraveling eConsent Ethics Committees and Health Authorities submission document requirements to foster wider adoption.


Florence

Latest:

Creating an Integrated Digital Pathway for Sites and Sponsors

*** Thursday, June 17, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST *** Join this webinar to hear best practices on how to enhance site-sponsor collaboration, compound efficiencies and accelerate trials by enabling end-to-end document exchange between sponsor eTMF systems and Florence’s leading eISF solution through Cognizant SIP. ***On demand available after final airing until June 17, 2022***


Jessica Cronin

Latest:

Awareness of Clinical Research Increases Among Underrepresented Groups

Latest CISCRP study provides insight on proactive outreach.



Oracle Health Services

Latest:

Exclusivity or Collaboration in Clinical Trials - What's the Best Formula for Success?

*** Monday, May 24, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST *** Most organizations deal with the vulnerabilities that exclusive point solutions create. Join industry leaders Oracle and IQVIA to understand how inclusivity and a flexible environment can help you employ new approaches faster, and the benefits of collaboration in today’s clinical trials ecosystem.*** On demand available after final airing until May 24, 2022 ***


Zhuxing Yao

Latest:

The Regulatory Requirements and Key Points of Drug Clinical Trials Registration in China

Following the implement of new Drug Registration Regulation in July 2020, the clinical trial registration system will have some major changes in China.


Tony Fantana

Latest:

How Remote Patient Monitoring Technology Can Impact Decentralized Clinical Trials

What is next for DCTs after acceleration from COVID-19?


Luis A. Rojas, PhD

Latest:

The Transformation of Clinical Trials from Writing on Papyrus to the World of Technology

New requirements must be put in place to ensure data quality and integrity.


Robin Rogiers

Latest:

Regulatory Considerations Surrounding Human Challenge Studies with the SARS-CoV-2 Virus

A first vaccine against this coronavirus could still take some time to develop, but mRNA vaccine platforms could offer an early breakthrough.


Ronald Du

Latest:

4 Key Actions ClinOps Can Take Now to Avoid Disruptions

Biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.


Abigail Dirks

Latest:

Introducing PALADIN

First-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.


Perla Nunes

Latest:

Clinical Research Needs Greater Participant Diversity

COVID spotlights the troubling disparity in clinical research representation. How can we remove these barriers?




Massimo Zaninelli

Latest:

Clinical Trial Disclosure and Data Transparency: Obligation or Opportunity?

Implementing disclosure and data transparency policies and procedures represents an opportunity for sponsors, rather than an obligation.


OM1

Latest:

Rapid and Scalable Real-World Evidence Generation with Study Automation Platforms

Sonja Wustrack, OM1, highlights a new clinical study automation platform to support critical data collection and real-world evidence.


Jennifer Christian, PhD

Latest:

Augmenting Single Arm Oncology and Rare Disease Trials with Real World Evidence

RWE can augment, extend, or enrich the findings from clinical trials to provide valuable evidence to support the development programs for product approvals.

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