In Pursuit of eConsent: Best Practice Recommendations for Successful Integration
Electronic informed consent (eConsent) solutions have been introduced in recent years, representing a major advancement in improving information delivery to…
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Clinical Development in Challenging Cancers: Adrenocortical Carcinoma
Adrenocortical carcinoma (ACC) is a rare cancer with an estimated incidence of 1 to 2 patients per million people annually.…
Companies Need More Awareness of EU Pediatric Investigation Plans (PIPs)
Pediatric legislation was introduced based on the American Academy of Pediatrics (AAP) concerns that children did not participate sufficiently in…
Constructing Composites to Optimise Cognitive Outcomes
Henry J. Riordan, Ph.D., Executive Vice President of Medical and Scientific Affairs and Global Lead for Neuroscience at Worldwide Clinical…
Clinical Trials in Central and Eastern Europe: Keeping Up with Global Competition
A great number of willing patients, highly experienced researchers and EMA-compliant legislation make the CEE region an attractive research site…
Clinical Trial Enrolment in China: The Potential Role of Patient Advocacy Groups and Digital Health Networks
China has a large and vibrant ecosystem of patient advocacy groups and digital health networks that provides clinical trial sponsors…
Risk-based Monitoring: The Innovative Model Redefining Clinical Trial Risk Management
One area in the clinical trial process that has been identified for improvement is risk-based planning and management. Monitoring and…
CDISC for Non-Experts Everything You Always Wanted to Know About CDISC (But Were Afraid to Ask)
CDSIC is meant to enable you to collect, store and transfer clinical data in a way that makes them easily…
The Challenges and Benefits of Biosimilar Drug Development for Trastuzumab, a Precision Medicine
Monoclonal antibodies (mAb) are among the most promising biologic drugs currently on the market for treatment of life-threatening diseases. The…
Pharmacovigilance’s Growing Influence
Pharmacovigilance will always be about protecting patients. The discipline is rapidly evolving into something greater than regulatory compliance; increasingly, pharmacovigilance…