Aug 24
Investigators Face Challenges in Writing Research Protocols in the Age of Remote Working
24 Aug, 2020. 0 Comments. Articles, News. Posted By: Kenan Aktulun
A report by NPR, based on federal clinical trials data, showed that the COVID-19 pandemic has forced hundreds of clinical trials to stall. Academic medical centers, hospitals and community research centers have all seen some clinical trials stopped or paused. While some research institutions are slowly re-opening their campuses, many investigators and their staff are still working remotely from home, at least part time. This has had a significant impact on both industry sponsored and investigator initiated clinical trials. Some investigators, residents and fellows needing to do their scholarly research, are keen to initiate studies, particularly those that may not…
Sep 21
Centerwatch: “BRANY protocol launch showcases paradigm shift in behavioral and social sciences research”
21 Sep, 2017. 0 Comments. Articles, News, Press Release. Posted By: bflint
By Kathy Rembisz   Biomedical Research Alliance of New York (BRANY) released a new research protocol template specifically designed to address the unique needs of social-behavioral-educational researchers. This launch comes as part of Protocol Builder, a secure, cloud-based protocol writing application. This special template provides a guided, step-by- step protocol-writing process for investigators who specialize in psychology, nursing, educa- tion and other disciplines that are focused on behavioral and social functioning. “Social and behavioral research is distinct from biomedical research,” said Jeffrey Cohen, Ph.D., a principal with HRP Consulting Group, a division of BRANY. “The process of writing a protocol can be more…
Aug 15
Conducting a Successful Residency Research Project
15 Aug, 2017. 0 Comments. Articles, News. Posted By: bflint
Most medical schools, as part of the graduate medical curriculum, require residents to conduct at least one research project. These projects are designed to give clinicians early in their career an opportunity to manage a project, understand the importance of well-designed clinical research and to improve their communication skills. This may be the first time a resident goes through the entire process of writing a clinical research protocol that must undergo the rigorous review by their superiors and the IRB. Some institutions provide the resident with a mentor, or preceptor. But in some cases, the resident must rely on other…
Jul 27
Protocol Builder Launches Protocol Template for Social-Behavioral-Educational Research
27 Jul, 2017. 0 Comments. News, Press Release. Posted By: bflint
BRANY announced today the release of a new research protocol template specifically designed to address the unique needs of social-behavioral-education researchers, as part of Protocol Builder®, a secure, cloud-based protocol writing application. “Social and behavioral research is distinct from biomedical research,” says Jeffrey Cohen, PhD, a principal with HRP Consulting Group, also a division of BRANY. “The process of writing a protocol can be more subtle than an interventional drug study, for example.” “Although historically many social behavior researchers have not developed full protocols for their research prior to submitting to an IRB, many institutions are now requesting social behavioral…
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…