24 Feb

Posted at 15:20h in Articles, News, Press Release

For Immediate Release January 27, 2023 BRANY Announces Launch of Informed Consent Builder Tool New cloud-based application improves collaboration in developing compliant informed consent forms for research A new addition to the Protocol Builder® line of products, Informed Consent Builder™, was announced today. The cloud-based application is available as a fully integrated add-on to the protocol writing application or as a standalone product. “Our customers were asking for a solution that would create compliant informed consent forms for research with the same ease that Protocol Builder® creates detailed clinical research protocols,” says Paddy Mullen, President & CEO of BRANY. Informed Consent Builder™ is a natural extension of the suite of tools that we offer both large and small institutions, as well as biopharmaceutical companies and CROs....

24 Aug

Posted at 17:06h in Articles, News

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 require participants to make in person visits to medical facilities. The FDA has issued guidance on conducting clinical trials during the pandemic....

21 Sep

Posted at 18:32h in Articles, News, Press Release

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 subtle than an interventional drug study, for example,” said Cohen. He explained that while biomedical researchers are generally accustomed to preparing, sub- mitting and following...

15 Aug

Posted at 22:13h in Articles, News

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 sources for assistance, such as fellows or the medical librarian. A successful residency research project starts with a strong, well-developed protocol....

27 Jul

Posted at 17:28h in News, Press Release

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 protocol development templates as research in this area continues to grow,” says Kimberly Irvine, Executive Vice President and Chief Operating Office for...

07 Jul

Posted at 14:58h in News

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 criteria and whether additional non-clinical and/or clinical data on the proposed device resolve questions of safety and effectiveness. This means that a...

01 Apr

Posted at 16:21h in News

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] While at many institutions research is a non-mandatory part of the curriculum, many others are committed to sponsoring programs that encourage and...

21 Mar

Posted at 19:03h in Articles, News

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” approach, such as the FDA and NIH are proposing, can go a long way to alleviating delays and improve protocol design. Additionally,...

08 Oct

Posted at 00:27h in News, Press Release

(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 development of investigator-initiated clinical trial protocols that meet IRB and regulatory standards. The design was an essential element in guiding researchers...

09 Sep

Posted at 07:57h in News

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. In Lewis Carroll’s Alice in Wonderland, the King says to the White Rabbit, “Begin at the beginning, then go until you reach the end. Then stop.” He could have been telling an investigator about the process of crafting a clinical trial protocol. The synopsis is often used when investigators apply for grants or seek to obtain resources and other support to undertake the study. For medical school residents, a synopsis can be used as a discussion point with an advisor. For investigators...