Authors


Sheelagh Aird

Latest:

Central RBM Supports Reduced Cost, Higher Data Quality

Implementing centralized risk-based monitoring can help meet strict GCP requirements for study conduct, oversight, and recording.


Fenja Kruse

Latest:

What the Future of Study Review Processes Should Look Like

Insights from Bayer’s study review process showcases importance of incorporating feedback from a wider audience of stakeholders.


Anusha Shetty

Latest:

Four-Steps to Accelerate Study Start-up Cycles

Identifying KPIs, benchmarks, key data points, and an actionable plan are all keys to accelerating study start-up cycles.


Jaydev Thakkar, MBA

Latest:

How Today’s Digitally Driven Research Could Drive CAR T-cell Therapy Protocols of the Future

New protocols, remote patient monitoring, and improved standards of care among ways industry can take next steps in CAR T-cell research.


Harold Strandquist

Latest:

Better Cardiac Safety Trials

Tips for reducing site queries and improving workflows.


Ben Thomas

Latest:

What Patients Expect from Clinical Trials in the COVID-19 Era

Key takeaways from a survey of 250 oncology patients measuring COVID-19’s impact on patient willingness to participate in clinical trials.


Liisa M. Eisenlohr

Latest:

Targeting Patient Population

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


Julia Beck, PhD

Latest:

At-home Self-collection of Blood Specimens for Safety Lab Testing in Clinical Trials via the Tasso+ Device

Laboratory services organization focuses on easing patient and site burden with improved collection device.


Melanie Owen

Latest:

How to Address—and Overcome—Operational Challenges in Master Protocol Studies

Trials that address multiple questions simultaneously using a master protocol can be operationally complicated. These complexities can be managed, even in studies used to support a marketing application.


Lev Korolkov

Latest:

Evaluation of Different NLP Models for Parsing and Extraction of Clinical Data from Scientific Articles

Natural language processing models are able to automate the extraction of pertinent information from a vast array of scientific literature.


Dario Lirio

Latest:

The Impact of Automated Safety Document Distribution on Pharmacovigilance and Patient Safety

Automating process can reduce time and resources lost from using manual steps and allows stakeholders to maintain compliance.


Mike Willis

Latest:

Emerging Practices Employing CDISC Standards in Clinical Trials

Now that the industry has gotten some experience with CDISC standards, teams are aiming to get more from their standardization efforts.


Steven Lobel, PhD, D-ABMLI, MBA, FACB

Latest:

At-home Self-collection of Blood Specimens for Safety Lab Testing in Clinical Trials via the Tasso+ Device

Laboratory services organization focuses on easing patient and site burden with improved collection device.


Todd M. Bertoch, MD

Latest:

Unknowns That Can Make or Break a Non-Opioid Analgesic Clinical Trial

New and renewed approaches to improve chances of success in developing non-addictive drugs for chronic pain.


Raj Sharma

Latest:

A Primer on Clinical Trial Virtual Waiting Rooms

Exploring their unique opportunity in increasing study enrollment levels.


Alejandra Guerchicoff

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.


Jennifer Kim and Dezbee McDaniel

Latest:

From Words to Action: Advancing Efforts to Reduce the Racial Gap in Clinical Research

Despite repeated calls from the FDA, patient advocates, and scholars for the need to address demographic disparities in clinical research, White participants still remain overrepresented while racial minority participants remain underrepresented in clinical trials.


Michael J. George

Latest:

Introducing PALADIN

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


Deep Sharma

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.


Melissa Mooney

Latest:

ePROs in Oncology: Breaking Through Barriers for Better Drug Development and Higher Quality Care

Industry now leveraging reporting system to empower patients and improve research.


Geraldin N. Batista

Latest:

Understanding the Complexities of Diversifying Clinical Trials

Tufts Center for the Study of Drug Development and Biogen recently conducted a study to inform growing interest in improving diversity of clinical trial participation. The results of this research provide insights into increasing the community of minority investigators and study staff and presenting greater access to clinical trials among minority study volunteers.

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