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SCIO Strategic Consulting
Sponsor companies are using a variety of outsourcing relationship models.
The Tufts CSDD completed a review and analysis of the different outsourcing relationships. Three functional areas were identified as clinical study requirements:
1. Study design and regulatory affairs
2. Site management and study monitoring
3. Data management and dossier submission
The results indicated that study design and regulatory affairs functions are retained in house and outsourced in less than 1 in 5 instances. Site management and study monitoring are on the contrary the heavily outsourced functions. The current status quo has generated a 21.5% reduction of drugs approved by the FDA, a 15% increase in clinical phase duration, and $4.4 billion mean annual cost per approved molecules compared to the 1990s.
A study by Vantage Partners concluded that the unhappiness of the sponsors with regard to the strategic partnership was linked to various causes including the presence of unreasonable expectations of the sponsor.
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.