Elite BioPharma Consulting, a Danforth Advisors company, collaborates with pharmaceutical, biotechnology and medical device companies to support their product development process from initial application through final regulatory filing. The firm’s founders and consultants deliver broad experience in all areas of clinical research for both drug and device development.
The Elite team applies deep-rooted knowledge to successfully execute both early and late phase clinical development programs for clients.
How Elite Can Help
Clinical Operations
In partnership with the client, Elite consultants play an integral role in clinical trial and team leadership, clinical trial oversight and management, clinical development planning, vendor oversight and clinical trial support. Roles performed: VP of Clinical Operations, Director of Clinical Operations, Clinical Project Manager, Clinical Trial Manager
Clinical Monitoring
Clinical Research Associates (CRAs) perform on-site and/or remote monitoring activities to ensure compliance with the study protocol and to ensure patient safety. Activities include: site training, site management, monitoring visits (qualification, initiation, interim/routine and close-out), source document verification, and clinical trial support.
Program Management
Experienced program managers undertake the following key activities: clinical development planning and management, program timeline and budget management, cross-functional team management, due diligence management, organizational gap analysis and transformation.
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