Project Management

Lotus Clinical Research provides skilled project managers that are well suited to the needs of analgesic trials. With an average tenure of 10+ years in the industry, our project managers have considerable experience in pain trials, with a focus on leading studies to on-time completion with the highest quality data to support regulatory submissions.

Our project managers are highly effective at rapid startups. By leveraging Lotus Clinical Research’s analgesic expertise and collaborative approach, from final protocol to first patient in, projects have been activated in as little as six weeks.

We apply classic project management principles to effectively meet timelines and project milestones by optimizing lines of communication. Our project managers will seamlessly function as an extension of your team from protocol development through delivery of the Clinical Study Report (CSR).

As your single point of contact, the project manager will lead your study in:

•  Timeline development and management
•  Protocol and Informed Consent Form (ICF) development
• Study plan development
• Patient reported outcome diary development
• Site selection
• Vendor management
• Recruitment strategies for targeted populations
• Risk mitigation: includes identification, analysis, response, and quality control
• Monitor and site performance management
• Study team, Clinical Research Associates and clinical sites communication