The Drug Development department at EDDC is made up of 4 main parts and is responsible for pulling a project together as it prepares to enter clinical trials. It is made up of clinicians who bring to the table years of industry experience.
The medical team functions as safety lead and sponsor medical oversight for all our clinical. This team is also able to navigate the nuances of designing clinical trials and managing subsequent clinical development planning.
The clinical operations team manages development and execution of all clinical studies. This also includes start up activities, CRO selection and oversight. The team also ensures that study quality is maintained.
CHEMISTRY, MANUFACTURING & CONTROLS (CMC)
The CMC team selects and manages CDMO/CMOs for contract manufacturing of small molecules and biologics (Drug Substance and Drug Product). This team provides oversight of CMC activities and supply of Investigation product for clinical trials.
The regulatory affairs team works closely with Singapore’s Health Sciences Authority (HSA) and the U.S. Food and Drug Administration (FDA) to coordinate regulatory efforts around clinical trials that EDDC is supporting. The team also works closely with scientific colleagues to offer regulatory consultations on IND submissions, development planning and regulatory submissions