Serenity Meds provides comprehensive clinical trial monitoring and management that includes BA/BE. All monitoring activities are conducted in accordance with ICH GCP guidelines and applicable regulatory guidelines. Serenity Meds develops a Sponsor-approved monitoring plan for each study. Monitoring visits are conducted at pre-determined intervals and/or as the study needs dictate.
Medical Writing
Medical Writing is an integral part of clinical research. Our Medical Writers work closely with our colleagues in the biostatistical, pharmacovigilance, project management, and clinical data management teams to deliver accurate, timely, and cost effective documents to the highest ethical and scientific standards.
Clinical project managers
Oversee study plan implementation
Prepare and/or review budgets and other financial aspects of the study
Design study timelines
Prepare kick-off meeting to discuss roles & responsibilities with project team members