Oct 8
BRANY’s ProtocolBuilder® Takes Two 2015 [app] design awards
8 Oct, 2015. 0 Comments. News, Press Release. Posted By: bflint
(Lake Success, NY) ProtocolBuilder®, a first-of-its-kind solution for writing clinical trial protocols, has received Gold Awards for “Best New Service Award or Application” and “Health Application” in the 2015 USA [app] design awards sponsored by design100. These awards celebrate creativity and innovation in design achievements by app creators and commissioners. They were presented at ceremonies in New York, Chicago, and San Francisco. “We are honored to receive this recognition for ProtocolBuilder®,” said Kimberly Irvine, Executive Vice President and Chief Operating Officer of the Biomedical Research Alliance of New York (BRANY), the company behind ProtocolBuilder®. “Our goal was to simplify the…
Sep 9
6 key elements to writing a strong clinical trial protocol synopsis
9 Sep, 2015. 0 Comments. News. Posted By: bflint
A clinical research protocol is a roadmap. In order to have a clear roadmap, it is important for the investigator to have a succinct and relevant synopsis that others can review at a glance for a general sense of direction. (more…)
Aug 20
Protocol Builder Launches Individual License Option
20 Aug, 2015. 0 Comments. News, Press Release. Posted By: bflint
Cloud-based solution allows investigators to simplify the development of clinical research protocols (Lake Success, NY) — Protocol Builder, the cloud-based solution for investigator-initiated clinical trials, is now available to individual researchers, including medical residents and fellows, according to the Biomedical Research Alliance of New York (BRANY), the developer of the system.   “Residents and fellows are often challenged with developing research protocols that meet IRB and regulatory requirements,” says Raffaella Hart, Vice President, IRB and IBC Services. “Protocol Builder provides an easy-to-navigate solution that guides individuals writing research protocols through an intelligent step-by-step process, saving time and effort.”   The…
Jun 26
Why Clinical Research Protocol Templates Don’t Work
26 Jun, 2015. 0 Comments. News. Posted By: admin
Writing investigator-initiated clinical research protocols can be a time-intensive and daunting effort. Investigators agree that writing protocols is difficult and time consuming. What are the key obstacles for researchers who want to write a protocol that meets IRB standards? How can institutions go beyond templates and investigator training to speed up the process of developing and reviewing protocols? Please enter your email to download the white paper.
May 18
Common Protocol Development Errors (Part Three)
18 May, 2015. 0 Comments. News. Posted By: admin
In the last of this three-part series, we explore common types of information or documentation that may be inconsistent in investigator-initiated protocol submissions to an IRB. 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. For researchers writing investigated-initiated research, the process may seem like a labyrinth of regulatory and institutional requirements. Generally speaking, most IRB submission errors fall into these categories: Incomplete submission Missing documentation Inconsistent information Inconsistent Information An IRB submission often…
Apr 3
Common Protocol Development Errors (Part Two) 
3 Apr, 2015. 0 Comments. News. Posted By: admin
Some investigators are unclear about what to include in a research protocol vs. what is supplementary information. For example, some investigators may consider recruitment materials to be supplementary information. However, a complete protocol should specify the “recruitment plan,” describing how potential subjects will be identified and contacted. This description should contain details about how, when, where and by whom identified individuals will be approached about possible participation in the study. If, for example, the investigator needs to access medical records…
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