StratDev | Xintera BV

Strategic Development

Project validation

Includes manufacturing, preclinical, clinical, regulatory aspects

Competitive landscape scanning
Review of competitor regulatory history and potential safety or efficacy issues
Literature review & meta-analysis of competitors
Clinical feasibility assessment
Development costing, timelines, net present value estimation
Target product profile development

Clinical feasibility assessment

Assess viability of required clinical development effort in function of internal factors (cost & time constraints) as well as external factors

Identify & validate alternative development pathways
Literature review of competitor clinical and regulatory history
Identify development risks, plan risk mitigation
Full clinical plan and protocol write-up

Corporate due diligence support

Support company decision making in mergers & acquisitions

Critical appraisal of dataroom materials
External Validation of assumptions through literature review and meta-analysis
Explore original clinical trial datasets for clinical signals, subgroup differences and other efficacy/safety concerns
Estimate costing, timelines, net present value

Post-approval product support

Generate impactful publications though targeted Phase 4 research and mining of existing data

Identify unaddressed questions/clinical needs
Design and execute value-added Phase 4 study protocols
Pool original clinical datasets for individual participant data (IPD) meta-analysis
Publish systematic literature reviews based on published (competitor) data and sponsor IPD clinical data

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