Clinical studies are complex and sometimes daunting projects. They require a lot of resources, many different expertises and skills, and deep commitment by patients, study team members and sponsor. Thorough planning and preparation, continuous oversight and communication, and meticulous documentation and analysis—all according to ICH and other regulatory guidance—are key to achieve the aim of every study: High quality data that enable solid evidence-based conclusions on the questions investigated by the study.

Individual clinical studies are part of an entire development program. Demonstration of efficacy and safety of a new treatment are necessary but not sufficient to achieve success – at the same time, intellectual property, market access and reimbursement, and the role of the new therapy in standard treatment pathways need to be considered and appropriately addressed. A comprehensive planning process involving all current and future stakeholders can align a development program with overall portfolio and business strategy, with market access and commercial constraints and priorities.
What we offer:

  • Strategic and scientific advice on the clinical development of pharmaceutical products meeting current and future regulatory requirements and standards
  • Review, quality control or generation of scientific and clinical study related data, reports and essential documents according to ICH Guideline E6(R2)
    • Investigator’s Brochure (IB)
    • Clinical study protocol
    • Clinical study report
    • Study oversight and risk management plan
  • Generation of reports, summaries, expert statements, briefing books
  • Organisation of and attendance at meetings with regulatory agencies (e.g., scientific advice meetings, protocol assistance meetings)
  • Regulatory applications for
    • Orphan Drug Designation (EMA, FDA)
    • Paediatric Investigation Plan (EMA)
    • Pediatric Study Plan (FDA)
    • Clinical Trial Applications
    • SME status (EMA)
  • Advice on commercial valuation and business development
    • Review or generation of business case presentations for partnering and out-licensing
    • Due diligence - evaluation of clinical and regulatory documents offered for in-licensing
    • Advice on go/no-go decisions