Proven effective achievement in clinical research and product development in the BioTechnology Industry.

 
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Background & Expertise.

David Ramies has over 25 years of experience in the pharmaceutical industry with such companies as Bayer, Genentech and GSK.

Early-/late-stage clinical development:
- Clinical trial start-up
- Trial oversight
- Medical monitoring

Medical Affairs:
- KOL management
- Publication planning
- Medical writing
- Presentation materials
- Training liaison/sales personnel
- Review of promotional materials
- Product launch
- Life-cycle support

 
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Our Services.

We will work closely with you and your team in the planning, execution and completion stages of studies. 

Our services include, but are not limited to:
- Protocol development
- CRF design
- Site qualification/activation
- Data review
- Medical management
- Medical writing
- Filing preparation
- Label development
- Clinical reviews
- Training MSL/Sales staff
- Publication plans
- Medical communications

 
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Our Results.

Timely completion of clinical trial start-up and enrollment, while maintaining excellent data quality and minimizing subjects lost to analysis; shortening the time to database lock and report development. 

Building a solid foundation for product label development early in study execution to focus data collection/ correction appropriately and establish key messages for study reports, publication and product launch.

Effective launch with timely publication support for medical communications as a result of appropriate collaboration with opinion leaders and experts, and effective training of MSLs and sales staff.