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 Project & Trial Management
In partnership with the client, Elite consultants play an integral role in the planning, management and delivery of the numerous functions involved in clinical trials. Activities include protocol development, project team and vendor management/oversight, establishment of timelines and key milestones, and overall project management and delivery.
Clinical Monitoring
Elite Clinical Research Associates (CRAs) perform on-site and/or remote monitoring activities to ensure compliance with the study protocol and to ensure patient safety. CRAs are responsible for a multitude of tasks, including site management and study conduct (Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visit and Close Out Visits). The CRA is responsible for ensuring data is delivered within timelines and required quality standards and for adherence to monitoring procedures in accordance with GCP, ICH, local regulations, SOPs and the Clinical Monitoring Plan.
Program Management
Clinical programs require well-coordinated oversight across different functional areas within a clinical trial. Elite can provide program management on the client’s behalf to oversee coordination across all development functional areas, timelines, corporate milestones, budgets, risks and resourcing.
Regulatory Affairs
The Elite team provides regulatory consulting support for new and ongoing programs. This includes regulatory strategy, IND/IDE preparation and the coordination of NDA/PMA/510K submissions. They also provide regulatory communication oversight, including annual and routine reporting, i.e. DSUR, IB updates, safety reporting, etc. The Elite regulatory experts can serve as the US FDA Agent on behalf of clients.
Medical Writing
Experienced medical writers are available to support or manage the client’s full spectrum of required documents, including protocols, Investigator Brochures, annual reports/DSUR, clinical study reports, and safety narratives.
How else can we help?
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