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