News

IMS data show the importance of the role clinical investigators play in prescribing.

Subject Recruitment: The Ideas Initiative Trial Design: Early Phase CNS Drug Liabilities; Improving Enrollment Forecasts Also in this issue: Update on Europe's Clinical Trial Rules Debate Public Perception of Clinical Research Clinical Trial Barriers

Regulatory: Assessing Study Drop in CEE Swiss Syncs Up Regulations Sites: Regional Risks in Eastern Europe Also in this issue: Orphan Drug Hurdles in Europe Patient Engagement: Illness-Level Impact Clinical Trial Technology in 2025

Click the title above to open the Applied Clinical Trials December 2015/January 2016 issue in an interactive PDF format.

The Cantrixil Phase I study will be weighted towards ovarian cancer patients with the selection of a gynecological oncology site.

Ethical GmbH’s Ethical eAdjudication® Platform will be included in ACRES’ shared global platform of integrated technologies.

As cancer immunotherapies continue to emerge, the need for rigorous evaluation to assess the safety and efficacy of these products in clinical trials is critical. Doing so in the early phase setting requires a foundational focus in such areas as NME selection, protocol development, patient population, and investigator and site selection.

The industry is experiencing a paradigm shift from pharmacovigilance rooted in case processing and compliance reporting to a safety program built around benefit-risk management.

TRI will be providing the OPRA platform for all of Advanced’s studies whose sponsors have requested a risk-based approach to monitoring.

Without question, advanced cellular and gene therapies require well-defined cold-chain management solutions that reduce risk and include all elements of packaging, data collection and logistics expertise to ensure high-quality, effective treatments reach the point of care, and ultimately, the patient.