/Tag: Clinical Trials
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

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.

27 12, 2016

Managing the Complexities of Clinical Trials in the Dialysis-Dependent CKD Population

By |2020-01-31T15:00:16+00:00December 27th, 2016|Tags: , |

Ensuring timely, quality, cost-effective execution of ESRD clinical trials requires a research organization to leverage the right people, processes, and technology infrastructure to overcome the trial complexities inherent in ESRD drug development. This white paper explores the complexities of running clinical trials in advanced CKD and the ESRD populations and looks at the solutions that can be employed to overcome challenges.

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