A Freelance Writer for Medical, Clinical Trials, and Pharma Information
In Focus: Top Takeaways from FDA Final Guidance on Real-World Evidence
A look at the insights and implications surrounding the agency's recommendations on using RWE from electronic health records and medical claims data.
In Focus: Amid Heightened Industry Rules on Sustainability, How are CROs Faring?
With investors embracing the new regulations, a look at the progress CROs are making in their sustainability efforts
In Focus: Pharma Ramps Up Pursuits in Digital Technology
After a period of "fits and starts," large pharma companies are increasingly investing in digital health tools to reach business goals, be they through internal investments or strategic partnerships.
The Pulse of Modeling and Simulation in Clinical Trials
Experts weigh in on the latest advances and adoption trends.
More than Just Rules: Raising the Bar in GCP Adherence
Stepped-up training and real-time application key to avoiding compliance pitfalls.
Patient Data Return: Do the Benefits Outweigh the Barriers?
Experts explore potential paths to achieving buy-in from pharma and regulators.
Measured Momentum: Digital Biomarkers and Clinical Trials
‘No longer just a cool technology,’ efforts to validate these signals are evolving.
How to Rescue ‘Failed’ Clinical Trials and Minimize Risks
Strategies for intervention—or, ideally, averting potential pitfalls from the onset.
Raising its Profile: The Changing Practice of Pharmacovigilance
PV is on the road to becoming a leader, not a follower, in leveraging drug lifecycle information for clinical trials and to inform clinical care.
Data Equity: Representing Underrepresented Populations
Amidst difficulty in attracting underrepresented populations, industry is searching for ways to include more diverse datasets.
Progress Report: Pharma Adoption of Data Analytics
Assessing industry’s use and integration of clinical data science across business.
Key Guidance Updates in 2022
Summarizing important FDA and EMA revisions issued this year.
The Implications of Inflation for Drug Development
Experts gauge threat level for global trials amid staffing and funding issues.
The Risk-Reward Proposition for CGT Clinical Trials
As activity in this space grows, so do the hurdles in moving these products forward.
‘Record’ Gains in Bringing Research Closer to the Patient
Experts discuss solving the EHR-compatibility puzzle in point-of-care trials.
The Evolution of Site Selection
New support models range from flexible software platforms, IROs, and DROs.
The Post-Pandemic CRO Landscape
Technology, talent and specialization add up to a plethora of industry M&As.
The Future of Clinical Trial Design Looks Bright
Industry set to make choice on whether COVID-19 trials are the new standard.
The Many Paths of Diversity in Clinical Trials
How COVID-19 blazed a new trail for greater patient inclusion.
Maximizing the Value of Remote Monitoring
Pandemic-forced move to remote monitoring calls for industry-wide collaboration.
The Road to True Data Harmonization
eClinical, eSource and EHRs is the journey to the holy grail of data efficiency in clinical trials.