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Helping patients to achieve better outcomes


Our services

• We can help you plan and execute your project or simply get it back on track
• One of our associates becomes part of your team for the period you need us

• Evaluation of candidates for in-licencing and support for due diligence
• Product development strategy, strategic planning and roadmap development
• Risk-minimised approach to development of products

• Translation of preclinical data into clinical concepts and appropriate study designs
• Formulation of focused research enquiry in study design, eligibility criteria, target outcome measures and sample size feasibility
• SRD and MRD study design and protocol development
• Study design in small patient populations with high unmet medical need and unknown infantile to adult disease progression characteristics
• Utilising multiple compound study designs to successfully achieve a higher return over existing tried and tested methods
• Leveraging input from specialists / clinicians and patient advocacy groups
• Unique study implementation using innovative approaches, digital wear technologies, companion diagnostics development and home visits

• Advice on orphan drug development strategies and accelerated pathways
• Provision of regulatory information, guidance, training, support and strategic planning aligned with applicable regulations 
• Preparation of clinical, safety, regulatory documents for scientific advice, regulatory and ethics submissions e.g.    
DSMB charters, IBs, PSURs, IMPDs, orphan drug designation booklets, risk and benefit documents.

• Partnering clinical research organisations and key stakeholders to deliver global studies
• Budget and timelines management
• Team cohesion and cross-functional strategy alignment
• Best practice adaptation and contract negotiations


Unit 1
Cambridge House
Cambridge CB3 0QH


Phone: +44 (0) 7305 444087

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