Ensuring Safety for Clinical Trials
Safety
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Clinical Development
- Clinical Development
- Phase II-III Registrational Trials
- Long-Term Safety Programs
- Expanded Access Programs
- Global Site Management
- Risk-Based Clinical Monitoring
- Patient and Physician Recruitment & Retention
- Data Management & Biostatistics
- Regulatory Writing Services
- Quality Assurance
- Innovative Technology Platforms
- Clinical Trial Support - Home Health Nurses
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Late Stage Research
- Peri & Postapproval
- Phase IIIb -IV
- Postmarketing Requirements (PMR)
- Post Approval Safety Studies (PASS)
- Registries
- Market Access & Value Demonstration
- Burden and Cost-of-Illness Studies
- Retrospective Chart Review
- Prospective Evaluation of HEOR End-Points
- Time & Motion
- Surveys
- Real-World Data Analytics
Clinical Development and Late Stage Research
Our comprehensive global services help pharmaceutical and biotech clients prove their products’ efficacy, safety and value. With a focus on generating real-world evidence to obtain regulatory approval while maximizing ROI, UBC can develop a differentiated, value-oriented product position that will pave the way for increased market access.
As leading clinical research organization, we can implement and manage clinical trials from Phase II to Phase IV. Our teams of experts in clinical studies, patient recruitment, clinical data management, regulatory writing, nursing, and safety and pharmacovigilance collaborate with sponsors to help ensure conclusive study results and meet global regulatory submission requirements. We understand patient and population dynamics, global treatment practice patterns, and care-setting challenges.
For more than 30 years, UBC has partnered with life science companies on peri and postapproval studies. Our expert guidance positions products for approval and wide market access. We also have a long history of designing and implementing product and disease registries that address a broad range of issues, including safety, regulatory, research and education.
Our site-of-care nursing services coordinate clinical services by qualified, registered nurses in homes, medical offices and clinics. UBC’s extensive network has access to a trained clinician within driving distance of 90% of the U.S. population. Our home health nurses can also bring your clinical trial to patients’ doorsteps, offering convenient patient access to critical studies.
Our Value Demonstration team is celebrated in the pharmaceutical industry for designing studies that create compelling value messages. We offer a multidisciplinary team of expert researchers who are skilled in the design and implementation of evidence-based approaches to real-world data collection. Studies may be designed to stand alone, to populate economic models, or to quantify and compare real-world patterns of care, resource utilization, and clinical outcomes.
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Risk Management
UBC is a leader in safety data collecting and reporting for both clinical trial and post-marketing studies. We help pharmaceutical and biotech manufacturers maximize product performance by managing risk before, during, and after launch.
We offer a range of services, planned as a continuum across your product’s development and commercialization. These include risk based monitoring, clinical risk management, Risk Evaluation and Mitigation Strategies (REMS), and Risk Management Plans (RMPs). From early phase expert consulting through pharmacovigilance, our employees are the most experienced in their fields.
The Risk Management team is led by industry safety experts, globally by Dr. Annette Stemhagen, DrPH, FISPE, and in Europe by Dr. Janine Collins, MD. This team brings unmatched passion and commitment to your product and your reputation.
Pharmacovigilance
UBC provides technology and services that encompass safety/pharmacovigilance, risk management, signal detection, and assessment – as a comprehensive risk management program or as a stand-alone, targeted solution.
Characterizing safety events, identifying possible signals, and understanding their context efficiently and confidently requires extensive medical and regulatory knowledge and expertise. Led by industry safety experts, UBC combines a depth of experience with the newest and most innovative tracking technology systems. Our predictive insights lead to streamlined safety solutions that meet regulatory requirements. We host and support the Argus® safety database and have highly skilled safety scientists, safety physicians, and safety medical writers perform all pharmacovigilance activities
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