/Tag: Program Development
22 08, 2019

Rare Disease: 5 Steps to Successful Program Development

By |2020-02-07T12:34:25+00:00August 22nd, 2019|Tags: , , |

There may be as many as 7,000 rare diseases. Support from FDA, EMA and other regulatory agencies, combined with technological and scientific advances, have made it more feasible for pharmaceutical companies to give dedicated attention to orphan drug development. In doing so, they're developing medications for rare diseases that often have no cure and no available treatment. To ensure novel therapies advance from the lab to regulatory approval, a blockbuster-drug approach won't work. Managing rare disease studies to completion requires innovative thinking in nearly every phase of program development.

3 07, 2019

Biorasi Center of Excellence Spotlight: Oncology

By |2019-10-31T12:25:58+00:00July 3rd, 2019|Tags: , , |

Biorasi’s Oncology Center of Excellence remains at the forefront of this exciting field. Our team of clinicians, program managers and other experts stay up to date on the latest developments, from Tumor Infiltrating Lymphocyte (TIL) therapy to gene therapy advances. This experience, combined with Biorasi’s worldwide site network and data-driven approach, allows us to guide oncology programs to success—on time and on budget.

6 06, 2019

Prepare for Success: How Advance Planning Keeps Clinical Trials on Track

By |2019-10-31T14:41:50+00:00June 6th, 2019|Tags: , , |

Why Do So Many Clinical Trials Fall Behind? Clinical trials are not immune to missed deadlines and cost overruns. However, with proper advance planning, you can up the odds of success and avoid major glitches. Our studies show that about 33% of all clinical trials are behind schedule at any given moment. These trials under-perform due to operational failures; meaning, they’re behind schedule, over budget, or the data produced lacks the quality needed to support an approval.

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.

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