Mitigating Risk in Implementing Multi-Regional Trials in Multiple Sclerosis
Examining the main challenges in designing and executing MS clinical trials and proposing mitigation strategies that may help alleviate these burdens.
Specialized Safety and Regulatory Needs for Small and Medium Biopharma Companies
December 21st 2017Outsourcing safety responsibilities to functional service providers (FSPs) during clinical trials and post-approval can help small-to-medium-sized enterprises balance their workload and maintain best-practice operations.
Sponsors Ask: Is Our Trial Plan Realistic? Toward a Data-Driven Feasibility Assessment
December 21st 2017Today, a data-driven approach to feasibility assessment can help ensure that a sponsor’s clinical research plan is designed to enroll the right patients, rely on the right investigators, and take place in the right countries for success.
Anonymization and Redaction of Clinical Trials According to the EU Regulation
December 18th 2017Outlining the techniques for anonymization of clinical study reports and the identification and redaction of commercially confidential information to comply with EMA's Policy 0070 on trial data disclosure and transparency.