Clinical development
B2G Life Sciences provides senior clinical development expertise to biotechnology companies,
combining executive-level medical leadership, development strategy
and clinical trial oversight
to advance innovative therapies from early development through proof of concept and pivotal studies.
combining executive-level medical leadership, development strategy
and clinical trial oversight
to advance innovative therapies from early development through proof of concept and pivotal studies.
From study design to execution
Clinical Development Strategies
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Clinical Development Strategies
• Acting and Fractional CMO roles
• Indication validation & feasibility
• Clinical development plan elaboration
• Clinical protocol design following EMA & FDA regulations
• Complex and innovative designs
• External comparator arms
• Indication validation & feasibility
• Clinical development plan elaboration
• Clinical protocol design following EMA & FDA regulations
• Complex and innovative designs
• External comparator arms
Management of Scientific Boards,
DSMBs & Steering Committees
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Management of Scientific Boards
• KOL identification & management
• KOL interviews
• Advisory Board meeting organization & conduct
• DSMB & DMC board meeting organization & conduct
• KOL interviews
• Advisory Board meeting organization & conduct
• DSMB & DMC board meeting organization & conduct
Scientific & Medical Support for
Study conduct &
Patient Enrollment
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Study conduct & Patient enrollment
• Site identification & patient sourcing
• Patient enrollment strategy development
• Site visits & communication with investigators
• Rationale development & enforcement
• Medical monitoring & medical review
• Patient enrollment strategy development
• Site visits & communication with investigators
• Rationale development & enforcement
• Medical monitoring & medical review
Medical Writing
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Medical Review & Medical Writing
• Clinical protocol and study documents drafting
• Clinical study report drafting
• Regulatory submissions and interactions
• Scientific writing & publication
• Scientific support and medical communication
• Clinical study report drafting
• Regulatory submissions and interactions
• Scientific writing & publication
• Scientific support and medical communication
Trainings in the Businesses of
Biotech & Pharma
Industry
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Trainings
• ICH-GCP
• Quality assurance
• Clinical development
• Project management
• Quality assurance
• Clinical development
• Project management