Jul 7
New FDA Draft Guidance: the Importance of Literature Search in Writing IDE Protocols
7 Jul, 2016. 0 Comments. News. Posted By: Protocol Builder
The FDA recently released a draft guidance policy categorizing investigational device exemption (IDE) devices. The guidance was developed to assist the Centers for Medicare & Medicaid Services (CMS) in determining whether or not an IDE device should be covered (reimbursed) by CMS. The guidance has significant implications for research sites and investigators who are responsible for developing research budgets. The guidance specifically addresses new devices or approved devices that have been modified for a new use and may pose significant risk. This article addresses the latter — approved devices. The FDA intends to categorize devices based on a set of…
Apr 1
Training the next generation of clinical researchers via a guided experience
1 Apr, 2016. 0 Comments. News. Posted By: bflint
Most academic medical centers are driven by a three-pronged mission: Education Research Patient care At the core of this mission are their medical and surgical residents. Essential to a resident’s graduate medical education is research, according to the Accreditation Council for Graduate Medical Education (ACGME), which says “the curriculum must advance residents’ knowledge of the basic principles of research, including how research is conducted, evaluated, explained to patients, and applied to patient care.” In fact, as part of its accreditation requirements, it states that “institutions and programs should allocate adequate educational resources to facilitate resident involvement in scholarly activities.” [1]…
Mar 21
Why Standardizing Protocol Writing is Good for Research
21 Mar, 2016. 0 Comments. Articles, News. Posted By: bflint
The NIH and the FDA last week announced a draft clinical trial protocol template to help clinical investigators save time, and to encourage more investigators to engage in research. BRANY’s own research indicates that clinical researchers find writing protocols to be both time-consuming and difficult. Any tool that makes it more efficient for researchers and improves the quality of research protocols for institutions will benefit research overall. Over half of researchers have access to templates from their institutions. Often they can download them from Web sites. These can vary from one institutions to the next. A standardized “common protocol template”…
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…
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