United BioSource Corporation

United BioSource Corporation (UBC) is a global biopharmaceutical and medical device services organization that combines deep scientific knowledge with broad execution expertise across the product life cycle. Our focus is strategizing to identify, analyze and present real-world evidence to support the development and commercialization of medical products for emerging and established life science companies,

We partner with our clients to meet their needs with:

1. Expertise in safety, risk management, and pharmacovigilance;
2. Experts to provide strategic planning to guide evidence generation strategies and plans;
3. Scientific leadership in epidemiology, health economics, outcomes research, meta-analysis, data capture and biostatistics;
4. Extensive experience in peri- and post-approval research;
5. Clinical and strategic development services for emerging life science companies;
6. Data integrity and technology services to support training clinical professionals and managing clinical data from study conception to completion;
7. Investigator and patient programs to support investigators, study site personnel, clinical research subjects and patients;
8. Medical education, communication and market access programs.

Specific to safety, risk and pharmacovigilance offerings, UBC provides:
• Identification of areas that require risk management
• Design of risk management programs to meet regulatory requirements
• Design and implementation of disease, product and pregnancy registries
• Examination of real-world use of drugs and associated outcomes
• Understanding of drug safety issues and risk factors at the patient level
• Preparation of safety reports and manuscripts for regulatory, product marketing and medical communications
• Signal Detection & Evaluation
• AE/SAE Monitoring & Reporting
• Data Safety Monitoring Services
• Product Complaint Management
• Periodic Safety Update Reports (PSURs)
• Periodic Adverse Drug Experiences Reports (PADERs)
• Development of Risk Evaluation & Mitigation Strategies (REMS) and Risk Management Plans (RMPs)
• Development of Knowledge, Attitude & Behavior Surveys.

With over 2300 staff members, we are strategically positioned throughout North America and Europe and specialize in offering innovative ways to study drugs and devices with an emphasis on science, strategy, and execution.