A Modern Approach to Patient Education Increases Enrollment
Not every study presents a completely new and unique set of challenges. That’s not to say that the trial is generic, or not complex, but rather that Biorasi’s past work covers a large breadth and depth of experience. That experience allows us to see a lot of potential trial-stopping issues before they happen, and account for them in our planning. When we were asked to complete a trial on an acute lower back pain medication, we needed to identify potential pitfalls early in the planning process to make sure they wouldn’t lead to surprises later.
Flexibility and Strong Process-driven Planning Overcomes Regulatory Speed-bumps
The CDISC set of standards revolutionized data management in clinical trials by introducing a standardized model for data interoperability. The standard has been shown to decrease study data resource requirements by 60% overall, and 70-90% in start-up stages when implemented early. This results in dramatic decreases in cost, but also increases data accuracy and time to lock, to say nothing of the tremendous benefits having a standard dataset available in the course of the study. Download our whitepaper and find out how to make early CDISC work for your trial.
Operating a Pharmacovigilance Group in a Multicultural Global Environment: The way an individual interprets language is influenced by many factors, including culture, background, education, training, and personal biases. Read more in this white paper
Achieving optimization in CE trials means engaging in careful analysis and decision-making throughout the entire process. CE studies represent a significant expense for sponsors in both time and money. The process of designing and running CE studies is wrought with choices, decisions, tradeoffs and challenge. Explore Biorasi's vision to achieving successful CE ANDA clinical programs in ophthalmology.
Sponsors consider Russia as an attractive study venue due to the countries higher enrollment and patient retention rates and lower overall cost. This paper outlines the regulatory requirements for obtaining regulatory approval for clinical studies and addresses certain practical aspects of regulatory submissions in Russia.
The number of patients required in a trial is one of the cornerstones of the trial design. This number is calculated by using statistics, but the validity of any estimated number is totally dependent on certain assumptions. So before the estimates can begin, there are somekey questions that need to asked and answered. Read more in this Clinical Endpoint ANDA Program Optimization White Paper Series
Optimizing the Amount of Investigational Materials in ANDA Studies – Part Two
For Dermal Semisolid Clinical Studies […]
Clinical Endpoint ANDA Program Optimization White Paper Series: Optimizing the Amount of Investigational Materials in ANDA Studies – Part One
Over 30% of active clinical trials are seriously behind schedule. Find out the five signs that your clinical trial needs rescue before it's too late.