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Small, midsize, and non-US-based pharmaceutical and biotech companies face significant challenges in bringing new molecular entities into clinical development in the US. Smaller and non-US based companies frequently find themselves trying to stretch their capabilities as they attempt to meet the demands of the regulatory and drug development process.
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Drug Development Services
- Scientific Advisory Board Creation
- Study Design
- Protocol Development & CRF Design
- Project Management
- Site Selection and Management
- Study Site Monitoring
- Medical Monitoring and Safety Surveillance
- Data Management (EDC)
- Biostatistics
- Report Writing
- Regulatory Affairs
- Pre-IND Meetings
- IND Submissions
- Interactive Voice Response System
- Toxicology and CMC Consultation
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Best Practice has developed an approach that complements and supplements the leadership and staff of its client companies. We are program extenders. Our approach starts with the premise that each client has unique needs and requirements, and we offer an extensive menu of services on an as-needed basis. Unlike full-time employees, our services (and fees) can be managed on an as-needed basis. Unlike a large CRO, Best Practice prides itself in its responsiveness to the requirements of each of our clients, regardless of size, on a 24/7 basis. Our quality and cost sensitive orientation across the full array of drug development services has been likened to “just in time” manufacturing, with one client characterizing our service orientation as “concierge class.”
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