Clinical development

We serve as acting CMO and provide extended stand-alone as well as fully-integrated consulting services
to the biotechnology and pharmaceutical industry, with a particular focus on rare and orphan diseases, oncology,
as well as biotherapeutics and advances therapies.

From study design to execution

Clinical Development Strategies

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Clinical Development Strategies

• Acting CMO roles
• 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 *

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 *

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 *

Trainings in the Businesses of
Biotech & Pharma
Industry

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Trainings

• ICH-GCP
• Quality assurance
• Clinical development
• Project management

* in collaboration with our preferred partner