London, UK: +44 (0)333 332 1882 | Cambridge, Massachusetts: 617-674-2650 | San Mateo, California: 650-378-1270

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Clinical Development

Regardless how early you are in pre-clinical explorations or late in clinical drug development we will help you maximise the value of your compound based on its characteristics, available investigational and literature data, current business and regulatory environment, and your strategic targets. We can optimise your clinical development program to demonstrate clinical value based on budgetary and time constrains, advice on clinical trial design, and support you throughout your progress. 

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Translational Science

  • Medical support to candidate selection
  • Support through pre-clinical pharmacology to first-into-man study
  • Designing effective phase I-II programmes to establish clinical value
  • Insightful efficacy and safety measurement assessments
  • Creating new approaches, taking advantage of advances in technology and study design whilst aligning with emerging Regulatory Agency disease and device guidelines
  • Due diligence
  • Applying years of experience & knowledge to your portfolio evolution

Clinical Science

  • Clinical development plan
  • Clinical study design
  • Protocol development, addressing the needs of the key stakeholders, e.g. regulatory authority (what is the exact hypothesis we need to test, and how it will translate into label), payor (what is the evidence gap that the payor is concerned about)
  • Medical monitoring, support to CRAs and investigators, preparation of monitoring plan
  • Medical contribution to IMPD, IB, CRF, ICF, submission documents etc.
  • Interactions with key opinion leaders, preparation of advisory boards, etc.
  • Investigators meeting - protocol specific training to site staff
  • Establishment of Data Safety Monitoring Boards (DSMBs) and Data Monitoring Committees (DMCs)
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Medical Writing

  • Investigator brochure
  • Investigational Medicinal Product Dossier 
  • Clinical Study Protocol
  • Clinical Study Report
  • Development Safety Update Report