//July
12 07, 2017

Clinical Trial Planning Saves ALBP Trial some Pain

By |2020-05-19T13:07:28+00:00July 12th, 2017|Tags: , |

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.

12 07, 2017

Putting CDISC Standards to Work

By |2020-01-31T13:21:46+00:00July 12th, 2017|Tags: |

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.

12 07, 2017

Optimizing Ophthalmic CE ANDA Trials

By |2020-02-03T12:01:54+00:00July 12th, 2017|Tags: , , |

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.

12 07, 2017

Navigating through the Clinical Trial Authorization Process in Russia

By |2020-02-07T11:44:41+00:00July 12th, 2017|Tags: , , |

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.

12 07, 2017

Patient Numbers Required In Clinical Endpoint ANDA Trials

By |2020-02-07T13:24:58+00:00July 12th, 2017|Tags: |

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

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