Clinical Development & Late Stage Research

Patient centricity in clinical trials
UBC - September 08, 2016
This year may go down as “the year of the patient” thanks to the explosion of discussion around patient-centric design – both in clinical studies and commercial support programs. Sponsors and CROs are embracing the opportunity to...
UBC - September 06, 2016
Proving therapeutic equivalence is an important step in the approval process for a biosimilar. The research needed is time, labor and resource intensive, making it critical to maximize the investment. UBC’s Clinical Development team...
Patient advocacy groups in clinical trial development
Shazia Ahmad, Director, Patient & Physician Services - August 31, 2016
More and more, sponsors recognize the importance of the patient perspective in clinical research. And when it comes to clinical research for rare and orphan diseases, the relationship with patient and advocacy groups is especially...
Hybrid Study for Pharmaceutical Value Messages
Erwin De Cock, Scientific Consultant and Kristy Hanson, Scientific Consultant - August 25, 2016
Real-world data on effectiveness, safety, and other outcomes are increasingly being demanded by multiple stakeholders. Data can be obtained using secondary data sources (electronic medical records, claims/administrative data, existing...
FDA guidance for rare diseases
Irene Pan, MSc, Senior Research Scientist - August 18, 2016
By definition, a rare disease affects less than 200,000 Americans.1 Currently, there exists an estimated 5000-8000 rare diseases affecting more than 25 million Americans.2 The lack of adequate understanding of the pathophysiology and...