Business Process Outsourcing

PRODUCTS

  • Predict Genotoxic & Carcinogenic Endpoints to Meet ICH M7(R2) Guidelines

    ACD/Impurity Profiling Suite predicts a variety of toxicological endpoints to help you assess the genotoxic and carcinogenic potential of impurities and degradants. Developed through a collaborative agreement with the US Food and Drug Administration (FDA), the software can be used as part of your ICH M7(R2) workflow—to help prepare regulatory submissions and remain compliant.

    • Determine the ICH M7(R2) classification for impurities and degradants
    • Predict 21 toxicological endpoints from structure; for mechanisms of hazardous activity including:
      • Mutagenicity (AMES test and other procaryote and eucaryote test systems)
      • Clastogenicity
      • Other DNA damage
      • Carcinogenicity
      • Endocrine disruption mechanisms
    • Identify potentially hazardous structural fragments responsible for carcinogenic and genotoxic activity
    • Gain insight into the possible mechanisms of toxic effects
    • Assess the reliability of predictions
  • Boost patient engagement. Simplify and reduce site workload. Enable real-time, local currency payments through the patient’s preferred method.

  • Scale up your viral vector or gene therapy manufacturing cost-effectively with HEKima Adherent, a QuickStart Media designed to simplify customization and accelerate development and production.

  • Patients shouldn’t have to jump through hoops. Discover an innovative portal that lets them handle travel and reimbursement directly—securely, simply, and without extra calls to the site.

  • Industry leading pharmacovigilance solutions from clinical development through post-approval.

WHITE PAPERS AND CASE STUDIES

NEWS