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NEURODEGENERATIVE DISORDERS, MOVEMENT DISORDERS AND RARE DISEASES
• SPECIFIC BACKGROUND INFORMATION
– Epidemiology
– Clinical profiles & unmet needs
– Competitive environment
– Major stakeholders
– Clinical profiles & unmet needs
– Competitive environment
– Major stakeholders
• IDENTIFICATION OF CLINICAL & MARKET OPPORTUNITIES
• DISEASE BURDEN AND REAL WORLD EVIDENCE
• CRITICAL EVALUATION
– Existing studies and other documentation
– Gap Analysis
– Gap Analysis
• ANALYSIS OF MoA TO SELECT TARGET INDICATIONS
• GUIDANCE ON SELECTION OF PRECLINICAL MODELS
– Target engagement
– Mechanism of action
– Proof of concept
– Mechanism of action
– Proof of concept
• ADVICE ON TAILORING TOXICITY STUDIES
CLINICAL DEVELOPMENT :
• Scientific review of documentation on files
• Advise and support for clinical development plan
• Guidance on building the evidentiary basis for regulatory approval
• Strategic guidance on clinical portfolio management
• Advise and support for clinical development plan
• Guidance on building the evidentiary basis for regulatory approval
• Strategic guidance on clinical portfolio management
CLINICAL TRIAL DESIGN :
• Trial design selection from early to late phase development
• Development of innovative clinical trial designs
• Selecting outcome measures (Biomakers, Continuous monito-ring/Sensors/Remote assessment, Scales …)
• Development of innovative clinical trial designs
• Selecting outcome measures (Biomakers, Continuous monito-ring/Sensors/Remote assessment, Scales …)
STUDY IMPLEMENTATION :
• Clinical trial operational guidance:
– Selection of advisory boards, kols, sites and clinical operations team
– Identification of high-quality clinical trial sites and of opportunities & barriers to recruitment for clinical trials
– Troubleshooting
– Risk mitigation regarding feasibility
– DSMB
– Selection of advisory boards, kols, sites and clinical operations team
– Identification of high-quality clinical trial sites and of opportunities & barriers to recruitment for clinical trials
– Troubleshooting
– Risk mitigation regarding feasibility
– DSMB
BUSINESS DEVELOPMENT
• Evaluation of unmet medical needs
• Review scientific rational and strategic goals
• Assist with partnering for acquisition or licensing of medicinal products
• Provide disease area information to funding partners
• Due diligence
• Repurposing
• Review scientific rational and strategic goals
• Assist with partnering for acquisition or licensing of medicinal products
• Provide disease area information to funding partners
• Due diligence
• Repurposing
MARKET ACCESS STRATEGY
• Development of medical operating plans (MOPS)
• Review risk management plans
• Post-marketing development strategies
• Support in developing market research
• Competitive landscape review
• Advice in pricing & reimbursement
• Review clinical commercial strategy
• Review risk management plans
• Post-marketing development strategies
• Support in developing market research
• Competitive landscape review
• Advice in pricing & reimbursement
• Review clinical commercial strategy
• Strategic advice for regulatory meetings
– Identification of the critical points
– Review of documents
– Participation in meetings
– Debriefing
– Review of documents
– Participation in meetings
– Debriefing
• Assistance in developing regulatory submission documents
• Support scientific advice processes including response to regulatory lists of questions
• Support for Orphan drug regulatory process
– Orphan Drug Designation
– Protocol Assistance
– PRIME (priority medicines)
– Fast track designation
– Protocol Assistance
– PRIME (priority medicines)
– Fast track designation
• Advice on
– EU device regulation,
– Device-drug combinations
– Validation of remote monitoring devices
– Device-drug combinations
– Validation of remote monitoring devices
