Authors


Elena Izmailova, PhD

Latest:

Breathing New Life into Respiratory Clinical Trials with Digital Biomarkers

Increased data output from the use of devices can accelerate trials for this therapeutic area in need of new therapies.


Gwenyth Jones

Latest:

Establishing a Basis for Secondary Use Standards for Clinical Trials

Study seeks to understand how different forms of data meet the needs of researchers.



Keri McDonough

Latest:

Addressing the Cost Barrier to Inclusive Clinical Trials

In an era of rising healthcare expenses, reassurance about costs for patients in diverse communities is particularly important.


Roche

Latest:

Digital Biomarkers Solution shows pathway to reduced clinical trial sample sizes, shorter durations

Digital biomarkers provide a pathway to the future where clinical trial sponsors can potentially benefit from reduced trial duration and sample size. Learn more about these benefits from a simulated study.


Zurab Koberidze

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.


Sid Mohamoodally

Latest:

Driving Clinical Speed and Agility Post-COVID

Improvements in data management and collaboration forge path to greater efficiency.


Rik de Greef

Latest:

Africa is Biosimulation’s Next Frontier

The answers to meeting biosimulation's growing demand for talent may lie in Africa.


Kristin Mauri

Latest:

Unraveling DCT Misconceptions

DCTs can be a great tool for small-to-midsize pharma and biotech companies despite misconceptions of them being advantageous for only Big Pharma.


Sas Maheswaran

Latest:

Benchmarking Risks Across Therapeutic Areas

Study uncovers insights on the impact on safety, patient enrollment/retention, and compliance.



Rodrigo Garcia, MD, MS

Latest:

Lessons Learned in 2022 and the Impact on Drug Development in the Year Ahead

DCTs and RWD among topics for industry to focus on moving into 2023.


Raviv Pryluk, PhD

Latest:

Turning Uncertainty into Opportunity: Smarter Clinical Asset Evaluation Powered by Causal Machine Learning

Machine learning can help investors dive deeper into trial data to evaluate the true potential of an asset and uncover new hidden opportunities.


Ekaterina Bulaeva

Latest:

Language of Medicine: Translating Between German and English

The complexities behind these translations require specialized personnel who are nuanced in both medical cultures.


Abi Pesun

Latest:

Clinical Trials Are Changing—What Does This Mean For IRT?

Expectations for trial design will continue to change, and it’s critical that IRT vendors continue to listen to their customers and evolve their offerings accordingly.


Grant Playter

Latest:

FDA Launches Pilot Program Using Cancer Biomarkers to Mitigate Risk

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.


Jeremy Edwards

Latest:

Rare Disease Patients Overlooked During COVID

Survey data shows individuals are not informed on how COVID-19 could affect their conditions.


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.


Matthew Bush

Latest:

Scaling eSource-Enabled Clinical Trials: Hospital Perspectives

The challenges, opportunities, and strategic outlook for oncology research centers.

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