CLINICAL SAFETY STRATEGIES

WE UNDERSTAND THE IMPORTANCE OF DRUG DEVELOPMENT

  • Innovation keeps us ahead of evolving diseases, pandemics, and drug resistance.

  • Over $200 billion is spent globally on biopharma R&D each year.

    Just one new drug takes over $2 billion investment, 10–15 years and 7,000+ researchers.

    ~2,000 new early-stage clinical trials are launched annually — each a potential game-changer.

  • Over 80% of clinical drug candidates today originated from small to mid-sized biotech firms.

    Biotech leads around 70–80% of the clinical pipeline, especially early phases.

    Biotech firms are driving the future of personalized and precision medicine.

  • Saving lives and improving our quality of life.

    Powering precision medicine & responding to crises.

    Fuelling scientific progress & economic growth.

  • 30% faster with robust early safety data

  • 25% reduction, saving time and money

  • 2x higher likelihood of partnership/ funding due to early risk mitigation

  • <15% occurrence compared to ~40% industry average when PV is reactive.

STARTUPS WHO INVEST IN CLINICAL SAFETY SEE TANGIBLE RESULTS

It’s not about building a big team. It’s about embedding smart safety processes where they matter most.

In practice, early clinical safety is not a one-time activity but a continuous, adaptive process that evolves alongside the asset’s development.

Core elements are:

  • Development of your clinical trial safety infrastructure

  • Real-time safety surveillance

  • Collaboration between clinical operations and safety teams, early in trial design

  • Timely regulatory reporting e.g. SUSARs, preparation of DSUR’s and Investigator Brochures

  • Identification of risks and development of risk mitigation plans and developmental risk management plans (dRMPs)

Download our whitepaper

Contact us to download our whitepaper on Clinical Safety Strategies to understand how to get started, how to keep it lean, and the benefits for early stage clinical trials.