June 26th 2025
AI as an accelerator for data-centric, process-centric, and human-centric clinical research.
June 16th 2025
Navigating a complex drug development landscape, sponsors must rethink their approach to risk in study design and execution.
June 9th 2025
As stakeholders debate fair market value in clinical trial budgeting, a new task force works to align sponsors, CROs, and sites on transparency, sustainability, and efficiency.
May 29th 2025
A blend of FSO and FSP models in the landscape of artificial intelligence can ensure CROs stay up to date with the unique demands of industry.
May 28th 2025
While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.
Shifting Perspectives on Site Networks to Create Positive Change
Evaluating the lessons learned about trial sites from COVID-19 to form new strategies and improve patient safety for the future.
Key Cost Drivers in Clinical Research: Guide to Successful Budgeting
It's almost impossible to map out study budgets with absolute precision. Planning for the unexpected costs, such as those associated with slow enrollment, protocol amendments, and other contingencies—is vital.
Clear Scope of Work Specifications Makes for Strong CRO/Sponsor Partnerships
To optimize the Sponsor/CRO relationship, the final proposal must represent a win for both parties.
The ICR-CRM-IQVIA Research Network Collaboration Experience
A discussion of the impact of a strategic alliance in to facilitate operational success at the clinical trial site level in Malaysia.
A Journey: Biotech, FDA, and Safety Committee Responses to COVID
Sudarshan Hebbar, CMO of CalciMedica, reveals how the FDA, ethics committees, and safety consortia have responded to helping to advance the application of novel therapeutics towards COVID.
The Rise of FSP Outsourcing in Drug Development
Industry experts share their thoughts on the evolution of the functional service provider model, as demand for flexible resourcing grows.
Small Biopharma and CROs: Seeking Stronger Synergies
Stakes are high for emerging biopharmaceutical companies to get their relationships with CRO partners right from the outset.
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.
A Competency-Based Approach to Combating the Talent Wars in BioPharma
Creative approaches are needed to address the clinical research workforce “talent wars”
Clinical Trials Salary and Satisfaction Survey, January 2020
New Research Emerges to Challenge Steep Costs of Clinical Trials
The Institute for Safe Medication Practices has released a new study which breaks down the estimated costs associated with the approval of new pharmaceutical treatments.
CRO Oversight Roundtable
Excerpts resulting from the extended discussion on CRO oversight at the recent CBI Finance and Accounting for Bioscience Companies conference.
CROs Tackle Neurodegenerative Disease Studies
In this interview, Linda Rawlings, VP of Neurodegenerative Development at Synteract, elaborates on addressing the challenges of neurodegenerative disease clinical trials.
Janssen Advances Efficiency and Effectiveness in CRO Oversight Model
Joe Pollarine, Head of GxP Systems Strategy Director at Janssen, recently spoke about CRO oversight models and will expand on these models in this interview.
The Emergence of the Few: M&A in the CRO Industry
As the size, complexity, duration, cost, and globalization of clinical trials has grown, pharmaceutical and biotech companies have moved to outsource clinical activities to CROs to achieve a wide range of objectives.
Know Before You Go: Japan Trials
There are key cultural differences to be aware of before conducting clinical trials in Japan.
Think Big on Outsourcing: A Network Approach for Small Biopharma
Proposed partnership model explores the value of establishing alliances between CROs and networks of small and emerging biopharma companies.
Implementation and Usage of Data Monitoring Committees
Exploring sourcing model options for appropriate incorporation of DMCs into a clinical program.
The Metrics Behind High Performing Study Startups
A two-phase statistical analysis identifies the key performance drivers in clinical trial startup.
Integrating Managed Access Programs: Global Considerations
MAPs can effectively address unmet patient needs and become a cornerstone of product strategy.
Fine-Tuning CRO/Sponsor Interaction
Pharma needs to find a balance in working with Sponsors and CROs in order to streamline the study processes.
Developing a Successful Peer-to-Peer Mentoring Program
Clinical research organizations should look to peer-to-peer mentoring for professional development.
The State of CRO and Sponsor Relationships
Companies trusting each other and looking out for each other's interests is the hallmark of outsourcing.
Comprehensive Evidence Development: Progress and Opportunities
The goal is to have an evidence development framework that can answer a range of questions simultaneously.
Optimizing Efficiency
Oncology clinical trials: A case for Russia and Eastern Europe.
Biomarker-Driven Oncology Trials
Accelerating the discovery and delivery of personalized medicine.
Maximizing Oncology Imaging Data
Increasing development costs and high failure rates require earlier integration of imaging data in the Phase I setting.
Patient-First Approach to Improve Oncology Clinical Trials
Life can change in an instant, but there is one thing that always abides: hope.
DIY EDC Evaluation
Options have emerged that make DIY EDC technology more accessible to smaller organizations.
Clinical Trials in the Baltic States
The region has an appropriate population size, solid infrastructure, experienced nvestigators, and short timelines.