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

Management of Scientific Boards, DSMBs & Steering Committees

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Management of Scientific Boards

• KOL identification & management
• 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

Medical Review & Medical Writing

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Medical Review & Medical Writing

• Study conduct & medical monitoring
• 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