• Registries: Patient, Disease, Product, Pregnancy
• Post-Approval and Phase IV Studies
• Observational Studies
• Phase IIIb/Expanded Access
• Market Access
• Quality Measurement and Improvement Initiatives
• Benefit Risk Management/RiskMAPS/REMS
• Safety & Surveillance
• Health Outcomes/Health Economics
• Quality of Life
• Patient Reported Outcomes (PRO)
• Patient Retention
• Performance Tracking Systems
• Instrument Validation Studies
• Controlled Distribution Programs
• Post-Marketing/Regulatory Commitment
• Health Interventions
• Performance-Linked Access Systems
• Comparative Effectiveness Research
• Interventional Trials
• Observational Research and Registries (prospective and retrospective)
• EHR and Database Studies
• Chart Reviews
• Cost Effectiveness
• Comparative Effectiveness
• Products (Drug, Biologic, or Medical Device)
• Healthcare Services (including Procedures)
• Diseases or Conditions
Our Scientific Affairs team, comprised of epidemiologists, biostatisticians, pharmacists, health economists and clinicians, leads or assists in the development of scientific concepts and study protocols and guides study execution, analysis and interpretation. They also provide guidance, as needed, through study start-up and conduct to overcome practical obstacles, support study analysis and reporting, and disseminate information through articles and presentations.
We provide a full-service offering for real-world and late phase research, ranging from small regional programs to large global studies. No matter the size of your study, we focus on operational excellence in every step of the process. Our dedicated project teams provide the full spectrum of services ranging from project strategy and management to site recruitment and support to risk minimization and medical monitoring.
Technology plays a critical role in a successful real-world or late phase program and building the solution around the most appropriate technologies improves efficiency, return on investment (ROI), site satisfaction and decreases the time to results. We leverage specialized electronic data capture (EDC) technologies, including the patented Outcome System® for evaluating real-world outcomes through observational research and registries and select market-leading platforms for interventional trials that are designed for international use and localization. Through these technologies, we deliver added value to sponsors through access to robust project and safety metrics, real-time data and analytic tools.
Ensuring the right approach to the right question requires a comprehensive understanding of healthcare stakeholder needs. Deep therapeutic knowledge and understanding of the key issues combined with clinical experience from a global team of physicians drives more effective and efficient research. Quintiles offers HTA Watch, a web-based global repository of published HTA reports from 70 agencies in 31 countries. Reflecting the importance of the patient voice, Quintiles offers MediGuard, an online patient community of over 2.5M patients. Strategic insights such as these ensure that research can be designed to capture the right clinical and economic endpoints and patient reported outcomes.
Data Assets & Analytics:
Through a series of partnerships and networks, we offer the ability to work with new clinical data sources for rapidly and cost effectively answering key clinical and research questions on practice patterns, treatment effectiveness, complex diagnosis and care plans, disease prevalence and more with access to clinical, claims, and EHR data representing the leading aggregate and most rapidly growing set of records. We leverage these networks to enable studies with data from multiple geographies, multiple care settings including inpatient and outpatient and integrated data from other sources including claims, pharmacies and labs.
Adverse Event Management/Software, Case Report Forms, Data Management, Disease Management/Health Outcomes, Electronic Data Capture, Health Economics, Pharmacoeconomic/Pharmacoepidemiology Studies, Pharmacovigilance, Registries, Regulatory Affairs/Regulatory Strategy