April 14th 2025
An increase in protocol complexity is paving the way for machine learning models to optimize trial design.
April 10th 2025
The future of clinical trial design involves incorporating the patient experience into strategic asset planning.
April 9th 2025
Anticipating divestment, reallocation of investments, and retrenchment.
March 20th 2025
COVID-19 not only advanced scientific boundaries, but also transformed research methodologies and accelerated adaptive clinical trial design.
March 7th 2025
Teams must work together with technology solutions and optimize integration to unlock their full potential.
Ethnobridging to Accelerate Global Drug Development
Multinational pharmaceutical companies are under intense financial and competitive pressures to make the drug development process more effective and efficient, and to expand into a greater number of international markets.
The 505(b)(2) NDA Leveraging Other People's Data
The 505(b)(2) new drug application (NDA) provides a potentially streamlined path for sponsors who have developed improvements to drug products that have previously received FDA approval.
Bridging the Disconnect in Pediatric Clinical Trial Recruitment
Despite the growing need for pediatric-approved medications, clinical trial enrollment for pediatrics remains challenging.
Assessing Drug Impaired (or Enhanced) Driving
Expect the FDA to be looking at a new metric in the drug approval process: driving safety.
The Shift to a Centralized Lab Approach
Central labs promote scientifically objective results, through independence of action on a contractual basis with the sponsor.
Translational Medicine and Biomarkers
Transfer of knowledge between pre-clinical and clinical research is necessary to deliver effective medicines to patients.
Streamline and Improve Study Start-Up
Work is needed if true efficiencies are to be gained in clinical trial performance.
The Practical Implementation of Risk-Based Monitoring
Central statistical monitoring can improve RBM solutions by efficiently detecting errors, sloppiness, tampering, and fraud.
RBM in Late Phase
The reality of risk-based monitoring: history and successful implementation for late phase research.
Risk-Based Approaches
The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality.
Impact on the Future
The use of RBM may be the only way forward as long as the development of medicines relies on clinical testing.
Paradigm Shift
Risk-based monitoring ushers in the move from the traditional experimental design.
Integrating Patient Retention Strategies
Addressing patient dropout with an arsenal of tools that leverages both technology and communication.
Type 2 Diabetes Community-Based Recruitment Strategies
Community-based recruitment engages multiple stakeholders in a collaborative approach.
Patient-Reported Outcomes in Analgesia Clinical Trials for Chronic Pain
PRO measures enrich the evaluation of treatment effectiveness and help sponsors differentiate products.
The Changing Landscape of Cystic Fibrosis Clinical Trials
Changing demographics and evolving standards of care bring additional challenges when creating protocol designs.
Improving Clinical Trial Enrollment Forecasts Using SORM
A useful tool for clinical research professionals to estimate potential recruitment duration.
CNS Drug Liabilities in Early Phase Clinical Trials
Only eight percent of CNS drugs will reach approval, in part because of the high adverse effects standards.
Personalized Medicine
How partnering can speed companion diagnostic development.
Collaboration Planning
Sponsor-driven, CRO/recruitment provider collaborations propel cost-efficient study completion.
Some Things Work Better as Partnerships
Partnership agreements for CROs and eClinical technology providers can be as beneficial as sponsor/CRO partnerships.
Groundbreaking Strategic Partnerships
How Covance has achieved successful outsourcing relationships with pharmaceutical sponsors.
What Does the Future Hold for Clinical Monitoring?
Current commercial forces are working to accelerate the adoption of adaptive monitoring designs.
Tailored Latino Recruitment
Survey results show that the recruitment of Latino subjects requires specialized tactics.
Acronyms, Abbreviations, and Initials
Stay in the know with this list of up-to-date, commonly spoken, shortened words that are used often among clinical researchers.
Training and Education Directory
A listing of organizations, colleges, and universities that offer courses specific to advancing the education of clinical research professionals.
Professional Societies and Associations
Find out the latest on industry organizations and what they offer as membership benefits.
CDISC Clinical Research Glossary
The latest version of the glossary, providing hundreds of definitions for key terminology related to clinical research.
Pediatric Consent Errors
The intent of consent is that participants are comfortable with their choice and can comply with it.
Personalized Medicine Development
As the popularity of personalized medicine grows the role of the CRO continues to evolve.