Clinical development
We provide stand-alone as well as fully-integrated consulting services to the biotechnology and pharmaceutical industry, with a particular focus on rare and orphan diseases as well as biotherapeutics and advances therapies.
From study design to execution
Clinical Development Strategies
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Clinical Development Strategies
• Indication validation & feasibility
• Clinical development plan elaboration
• Clinical development plan elaboration
Management of Scientific Boards, DSMBs & Steering Committees
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Management of Scientific Boards
• KOL identification & management
• KOL interviews
• Board meeting organization & conduct
• KOL interviews
• Board meeting organization & conduct
Scientific & Medical Support for Patient Enrolment
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Patient enrollment
• Site identification & patient sourcing
• Patient enrollment strategy development
• Site visits & communication with investigators
• Rationale development & enforcement
• Patient enrollment strategy development
• Site visits & communication with investigators
• Rationale development & enforcement
Medical Review & Medical Writing
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Medical Review & Medical Writing
• Study conduct & medical monitoring
• Clinical protocol design & drafting
• Scientific writing & publication management
• Clinical protocol design & drafting
• Scientific writing & publication management
Trainings in the Businesses of Pharmaceutical Industry
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Trainings
• ICH-GCP
• Quality assurance
• Project management
• Quality assurance
• Project management