Health Economics & Outcomes Research

  • Cost-of-illness studies
  • Cost-effectiveness and cost-utility models
  • Opportunity and market evaluations for product development and licensing decisions
  • Design of economic and outcomes components for clinical trials
  • Analysis and modeling of clinical trial data
  • Clinical trial outcomes data collection and data management
  • Post-Approval/Phase IV Studies
  • Budget-impact models
  • Patient preference evaluations
  • Health-related quality of life (HRQoL) assessments
  • Post-marketing safety assessments
  • Physician decision-making studies
  • Work-site-based studies (productivity and safety)
  • Analysis of national survey data (e.g., NAMCS, MEPS)
  • Instrument development (focus groups, cognitive debriefing, pilot testing)
  • Validation (reliability and validity testing)
  • Interpretation (effect size, clinically meaningful difference)
  • Meta-analysis
  • Systematic review
  • Decision analytic models
  • Markov models

    • Clinical Development

  • Phase I-IV protocol development - including imaging studies for inhalation products
  • Initial dose setting based on preclinical data, indication(s) and delivery system
  • Preparation of investigator brochures (IB) and annual IND safety reports
  • Preparation of informed consent documents
  • Pharmacokinetic, drug-drug interaction and bioequivalence trials
  • Clinical Advisory Board selection and moderation
  • CRO selection and management
  • IRB selection and management Data management
  • Drug safety monitoring management
  • Statistical analysis
  • Clinical study report writing
  • Preparation for and representation at FDA/regulatory authority meetings
  • Interactions with FDA and other regulatory authorities
  • Paper and/or eCTD preparation of regulatory submissions (IND/NDA, CTA/MAA, BLA, ANDA etc)
  • Clinical trial submissions and updates to ClinicalTrials.gov

    • Environmental / Occupational Health & Safety

  • Pre-exposure third party risk assessments of facilities, system audits, and efficacy of EHS management systems and practices
  • Product containment and facility alarm systems
  • Post exposure root cause analysis, containment, decontamination, and clearance
  • Education, communication, and assessment of community concerns regarding environmental impacts and worker health and safety issues
  • Long-term epidemiological studies
  • Management, toxicological assessment, and review of new compounds and intermediates