Authors


Erika Ornago

Latest:

Vaccines Approved and Under Development Against COVID-19

Today's reality and the hopes of tomorrow of the COVID-19 pandemic—an updated mapping of vaccines authorized by regulatory bodies and those close to it.


Jai Singh

Latest:

Referral Partner Integration: Maximize the Efficiency of Patient Referrals

A win-win-win for sites, sponsors, and referral partners.


Mary P. Kotlarczyk, PhD

Latest:

Rare Disease Clinical Trials: Strategies Learned from Duchenne Muscular Dystrophy

Approaches sponsors, CROs, and investigators can take from the DMD experience.


Guillaume Gigon

Latest:

Harnessing Data Analytics and AI for Clinical Trials

Balancing these tools with operational efficiencies can aid CROs in meeting the evolving needs of sponsors.


John Hall

Latest:

Achieving Successful Decentralized Trials by Leveraging RBQM and Centralized Monitoring Oversight

As market factors drive the rapid growth of decentralized clinical trials, organizations should embrace risk-based quality management to evaluate the new dimensions of risk and ensure effective oversight of disparate data sources, writes John Hall.


Marco Anelli, MD

Latest:

Use of Televisits in Studies and Related PV Concerns

While televisits can address many medical concerns, one frequent reservation expressed by healthcare professionals is that patients during these televisits tend to present too narrow a picture of their clinical condition-resulting in non-comprehensive medical assessments.


Mike Martin

Latest:

Adapting Site Selection for Clinical Trial Decentralization and the Future Landscape

Sites not expected to fade away even as DCTs continue to grow past COVID-19.


Jordan Tapley

Latest:

Standardizing Site Clinical Trial Management with the eISF Reference Model

Clinical research sites feel growing pressure to perform work in a compliant manner while keeping pace with stakeholder information exchange workstreams, but lack the consistent processes to do so.


Yun Lu, PhD, Susan Li, Sarah Lawrence, and Sowmya Kaur

Latest:

Technology-Enabled Real-World Data and Clinical Research Data Integration in a Clinical Registry Ecosystem for Foundations

Spearheaded by disease foundations, the creation of clinical registries is streamlining data collection and driving informed decisions.


Deepu Joseph

Latest:

How Does FSP Models Complement eSource Implementation?

Biometric functional services, more than any other, can have a significant impact through the standardization of data collection and management.


Behtash Bahador

Latest:

Sharing Clinical Trial Results with Pediatric Participants

Survey uncovers pediatric-patient perspectives on plain language summaries.


Jen Lamppa

Latest:

Putting Diversity at the Center of Clinical Trials With Real-World Data

Robust data sets which can effectively represent diverse populations are key to driving greater inclusivity in trials.


Christine Bahls

Latest:

In Focus: The Top Needs in a Clinical Trials Software Package

Examining those technology-supported areas that sponsors, CROs, and sites consider the most valuable.


Joel Morse

Latest:

How Healthcare Economics Outcomes Evidence Can Pave the Way for Digital Therapeutics

In the face of chronic disease, DTx have the opportunity to provide a lifeline to patients.


Masoud Jamei, PhD

Latest:

Accelerating the Progress of Kinase Inhibitors in Oncology

The potential of PBPK modeling in answering key questions around these drugs.


Jia Chen, PhD

Latest:

Accelerating Breakthroughs with Synthetic Clinical Trial Data

The emergence of AI-powered simulants in improving study efficiency.


Lars Fransson

Latest:

eSource Interoperability Between EHR and EDC

Evidence from a Phase III cancer trial points to notable advances in data-transfer tech.


Jim Reilly

Latest:

Five Predictions That Will Drive R&D Effectiveness in 2025

A focus on data and process excellence advances product development.


Alexey Aleshin

Latest:

Pandemic-Proof Clinical Study Start-Up

The fear of exposure to SARS-CoV-2 in healthcare settings has deterred people from seeking care for non-COVID-19 diseases. One solution to patient care and biomedical research disruptions is implementing remote solutions for conducting research and collecting samples.


Marta Biase

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.


Vijaya Prajwala

Latest:

Targeting Patient Population

Keys to ensuring your clinical trials better reflect your target population.



Teresa Montes

Latest:

Best Practices for Clinical Trial Technology Integration

Data is the heart of clinical trials, so life sciences firms need to integrate their technology to keep data sources and trial portfolios up-to-date and secure.




Raj Indupuri

Latest:

Enabling Digital Transformation: Managing External Clinical Data Sources to Advance Drug Development

With an increasing amount of diverse data that must now be collected and analyzed, the industry is faced with increasingly complex studies that present new challenges in data management.


Ross Weaver

Latest:

Where Do We Go From Here?

Lessons from six months of conducting clinical trials during the COVID-19 pandemic


Flatiron Health

Latest:

Transforming Prospective Study Data Acquisition & Delivery

Learn how your team can use EHR-to-EDC technology to reduce data monitoring costs, speed up data cleaning timelines, and hit study milestones faster.


Purplelabs

Latest:

Optimizing Phase III Oncology Trial Recruitment with Data-Driven Insights

A pharmaceutical company aimed to launch a Phase III clinical trial for a new oncology drug, focusing on efficient and effective patient recruitment across diverse regions. They evaluated patient populations by analyzing demographics, social determinants of health, and geography. Investigator profiling included practice details, affiliations, referral networks, and clinical trial experience. The final step involved selecting and extracting target lists for implementation.


Michael Shipton

Latest:

Is There a Positive Return on Investment on a Virtual Site?

Anticipating the need for both virtual and traditional sites during the planning process can provide high ROI for sponsors.

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