Monika Dak

CSE is Centre of Excellence for Clinical Data. CSE identify clinical data insights (identify trends, signals and risks associated to trial endpoints and patient safety) to ensure data is scientifically plausible.

Partners with the Clinical Lead and local country Site Monitors in project execution. Provides centralized support to monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Monitors study start-up, manages resources, performs ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion. Leads team of Central Monitors(CM) and Clinical Analyst Support (CAS).

Provided project related support and assistance across multiple projects, sites and teams and reviewed the patient profile to ensure that the population participating in the clinical trial is in compliance with the protocol. Checking drug compliance, reviewing vitals and labs for unreported adverse events, reviewing concomitant medication to check prohibited medication.