Data Scientists

Our life sciences vertical data scientists have exceptional experiences in both data science and life sciences.

Core Skills Vertical Skills
  • Machine Learning
  • Nearest Neighbor analysis
  • Naive Bayes
  • Linear Regression
  • Logistic Regression
  • Bayesian time-series forecasting models
  • Decision Trees
  • Neural Networks
  • Cluster analysis
  • Natural Language Processing
  • Discriminant analysis
  • Support vector machines
  • Random forests
  • Classification and regression trees
  • Time series analysis
  • Python Programming
  • R Programming
  • SAS Programming
  • Accelrys Draw
  • ChemDraw
  • Chemical substructure searching
  • Broad experience in pharmacology
  • Antibody structure
  • Protein/DNA sequences
  • Value development planning
  • Clinical outcomes research
  • Utilization decisions and clinical outcomes
  • Patient Segmentation
  • Physician relationship channel optimization
  • Demand forecasting
  • Safety signal detection

Pharmacovigilance Experts

Our Pharmacovigilance Experts have exceptional experiences in both real world pharmacy and pharmacovigilance

Core Skills Vertical Skills
  • Pharmacology
  • Clinical Pharmacokinetics
  • Clinical Immunology / Hematology / Oncology Therapeutics
  • Renal / GI / Nutrition Therapy
  • Physical Assessment
  • Pharmacy Law & Bioethics
  • Endocrine Therapy & Special Patient Populations
  • Self Care and Home Care
  • Pharmaceutical Microbiology
  • Medicinal Chemistry
  • Drug Information and Literature Evaluation
  • Poison Management & Drug Abuse
  • Infectious Disease Therapeutics
  • Drug Delivery and Lab
  • Organic Chemistry
  • Systems Physiology
  • Pharmacy Convocations
  • Classification of adverse drug reactions
  • Types of adverse events
  • Product quality complaints
  • Individual case safety reports(ICSRs)
  • Spontaneous reporting
  • Adverse reaction vs. Adverse event
  • Literature reports
  • GXP and validation requirements
  • Medical terminology and MedDRA knowledge
  • Knowledge of PBRER/PSUR, DSUR and regulatory inspections

Computer Systems Validation Experts

Our CSV Experts have exceptional experiences in both systems validation fundamentals and FDA, EMA and MHRA regulatory requirements

Core Skills Vertical Skills
  • Enterprise System Change Management
  • IT Governance
  • Technical Writing
  • IT Service Management Communications
  • Incident/Problem/Change Management
  • User Access and Cyber Security Administration
  • Validation Plan (VP), IQ, OQ, PQ, Validation Summary Reports
  • Requirement Traceability Matrix (RTM)
  • FDA 21 CFR Part 11, 58, 210, 211, 820; ISO 13485, 14971; GAMP 4, GAMP 5; GLP, GCP and cGMP
  • EudraLex Volume 4 Annex 11: Computerised Systems (European Annex 11)