News

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text]It is a common sentiment among clinical investigators that the process of developing and submitting a human subject research protocol for review and approval by an IRB is onerous, lengthy and complicated. A protocol with missing, incomplete or incorrect information makes it difficult for an IRB to understand the trial, which can lead to increased protocol revisions, and delays in approval and enrolling participants. There is much that an investigator can do to improve the efficiency and turn-around time of IRBs by simply having a thorough and compliant protocol submission. The primary responsibility of an IRB is to safeguard human subject protection. To that end, the IRB reviews protocols in the context of adhering to...

Web-based and iPad tablet application solution for writing investigator-initiated research protocols (Lake Success, NY) — BRANY has announced the launch of Protocol Builder™, a first-of-its-kind solution to assist researchers in the development of investigator-initiated clinical trials protocols. This web-based application, accessible from any desktop and iPad tablet, is designed to provide expert guidance and a step-by-step process to make clinical trial protocol development faster and less onerous. Resources necessary to navigate the elaborate regulatory infrastructure that surrounds clinical research in the U.S. are at researchers’ fingertips in this thoughtfully designed application. “Many investigators find the regulatory and compliance hurdles difficult and time-consuming to navigate when writing protocols,” says Kimberly Irvine, Executive Vice President and Chief Operating Officer at BRANY. “Protocol Builder ensures...