Clinical Operations Support
The Douglas CDMO Clinical Operations Team are an experienced group of professionals who can assist your speed to market by coordinating the numerous parts involved in clinical trials. They can take responsibility for managing the day-to-day operations of clinical trials and work with sponsors, investigators, and other stakeholders to ensure that trials are conducted in accordance with applicable regulations and standards.
Our team can do the following activities for you to reach your Phase 1 clinical trial objectives:
- Assist in the design of the clinical trial with your Clinicians
- Drive the development of the trial protocol and other study documents
- Ensure regulatory compliance and obtaining IRB/IEC approval
- Identification, activation, and oversight of clinical trial sites
- Facilitate the appointment of appropriate clinical investigators
- Facilitating communication between various research teams to streamline collaborative tasks and help the study keep moving forward
- Finding, assessing, and choosing external vendors to partner with
- Stakeholder management and communications
- Quality control across departments
- Budgeting and financial management
- Trial closeout and reporting