Clinical Research Strategy, Planning and Decision Support

We help drug and development teams to design cost efficient clinical strategies and programs by providing scientific, clinical regulatory and business operations advice and assessments.
We specialize in orphan drugs, rare and neglected disease, diagnostics, oncology and infectious diseases. We assemble the right team of experts for open consultations, interim assignments and advisory support

Jobs we deliver:

• Clinical Development Plan and Review

• Clinical Program Design

• Feasibility and cost modelling

• Protocol design and study planning

• Regulatory advice

• Non-Interventional studies and Registries

• Advice on co-development and compound or device assessment

clinical development transactions 

We advise and support the writing of R&D contracts, structure outsourcing arrangements and assist with assessment of licensing opportunities and asset valuations using our dealligence framework.

Jobs we deliver:

• Situation/Challenge analysis

• NDA, Term sheet, Clinical Trials CRO & Co-development Agreements

• Outsourcing Management and Collaboration Management

• Negotiation Plan, Design and Strategy

• Customized tools

clinical research infrastructure 

We help to build research capacity in emerging regions by facilitating the participation in clinical research and providing training and sharing good practices.

Jobs we deliver:

• Facilitate research centres to establish links with medical centres in the communities

• Conduct trainings with on-site staff on Good Clinical Practice (GCP) standards and SOPs so that research meets all ethical and regulatory requirements