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Project Overview
Protocol Builder is a first-of-its-kind solution for writing all types of research protocols. Protocol Builder takes a highly complex regulatory and technical writing process and enables faster protocol writing and simplifies protocol writing research decisions with a comprehensive menu of carefully designed features. It helps research investigators and research staff at hospitals and academic institutions improve the quality of research protocols, adhere to strict regulatory standards to streamline the approval process and avoid multiple rounds of revisions. By doing so, it can help get important research off the ground faster with less resources.
Project Commissioner
Biomedical Research Alliance of New York (BRANY)
Project Creator
Team
Paddy Mullen - CEO, BRANY
Kimberly Irvine - EVP, BRANY
Kenan Aktulun - Founder/Executive Creative Director (Product Strategy/UX Design)
Brian Flint - Partner/Managing Director (Product Strategy)
Heather Mansfield - Partner/Creative Director (UX/Content)
Nina Cantafio - Consultant/SME (Content)
Michael Tardif - CEO, Sourcetop (Development)
Emily Avila - Calypso Communications (PR)
Project Brief
Protocol Builder is a game changer for writing investigator-initiated research protocols. These protocols detail the components of medical and scientific studies and must be approved before research can be given a green light.
The problem is that these protocols are time consuming and onerous to develop even for experienced writers. Poorly written protocols can also fail to meet strict regulatory standards resulting in rounds of revisions until approval is granted or can even result in the end to the study altogether.
That’s where Protocol Builder comes in.
Protocol Builder helps novice and experienced writers navigate the complexities of protocol development with a guided experience and robust time saving features. It also helps protocols adhere to regulatory standards so research can get approved and off the ground faster.
For instance, Protocol Builder sets up the table of contents and appropriate sections automatically based on the protocol type. It also has best practices and expert tips built in. In addition, it offers features, like a dashboard, advanced editing tools, downloadable forms, a library of educational links, and a final checklist to help ensure protocols are complete. See our fact sheet attached with the list of time saving features.
Protocol Builder was developed by the Biomedical Research Alliance of New York (BRANY), a leader in providing clinical research support services. Protocol Builder was developed using extensive market research into understanding the unmet needs in protocol writng from target users, academic medical center research leadership
and insights gathered from protocol writing experts.
Project Need
Protocol Builder changes the way investigator-initiated protocols, which are necessary to conduct new medical and scientific research, are written. There is simply no other solution on the market like it today.
Before it’s launch, protocol writers had to rely on copying and pasting content from other protocols or trying to dig up a Word template that might fit their needs. This can be daunting, time-consuming and lead to missing sections or topics, which can cause protocols to fail to meet the regulatory requirements needed for approval.
Now with Protocol Builder, users can simply select the type of protocol they want to develop from a drop-down list. This sets up the table of contents automatically along with needed sections and topics. If they’re unsure of their protocol type, they can answer a series of questions to get to the answer.
Protocol Builder also has many other time saving features. For instance, users have access to a library of educational and regulatory links, downloadable forms, and a final checklist to help ensure protocols are complete. In addition, it has review capabilities that help make it easier for users to gather and incorporate feedback.
All this means that protocols can get done faster and avoid rounds of revision before approval is granted. And this not only saves time and effort for protocol writers, but can also have a larger societal benefit by helping important medical research studies get off the ground faster.
User Experience
Protocol Builder streamlines and even eliminates many time-consuming tasks involved in protocol development. For instance, all users have to do to set up a protocol is choose the type from a drop-down menu. If they don’t know the type, they can answer a series of questions to get to the answer. Once the type is selected, the entire table of contents with all of the appropriate sections is set up automatically. And that’s just the beginning.
Users can take advantage of expert tips and guidance as they go through the writing process. They also receive alerts to help ensure they have what they need to meet strict regulatory standards and can be approved. In addition, Protocol Builder allows users to download required forms, browse a library of educational links, and run through a final checklist to help ensure the protocol is complete.
Protocol Builder also makes collaboration easier between colleagues and with supervisors. Users can email individuals a link to review their protocols, and comments can be added directly into the document. This helps make gathering and incorporating feedback simpler.
All of these features were based on in-depth interviews with target users and close collaboration with highly experienced protocol writers. Protocol Builder also leverages the experience of the Biomedical Research Alliance of New York (BRANY) who saw the need for this solution and spearheaded development.
BRANY brought in a team of design, content, and usability professionals to ensure Protocol Builder would be designed following best practices. The overall design is sleek, clean, and intuitive. It also mirrors familiar word processing programs in certain ways, so users could start writing protocols more easily.
Project Marketing
Protocol Builder was announced to our target audience with an exciting direct mail package and email that showed the benefits of this protocol writing “game-changer.” The email led to the website, which offers a tour of Protocol Builder and an opportunity to sign up for a free in-person or virtual demo. We continue to engage targeted audiences with emails that specifically address that audience’s needs.
The other pillar of our marketing strategy is to engage potential customers with relevant content in the form of articles, whitepapers and blog posts. We periodically post content to the website blog and a dedicated Protocol Builder page on LinkedIn.
Our engagement strategy is to communicate the application benefits to capture potential customer’s attention and drive to requests for an in-person on online demonstration. As we move forward, we will engage audiences in larger webinar demonstrations. These demonstrations are the starting point for Sales to understand the customer’s needs and provide assistance understanding pricing, license size customization and implementation (which is incredibly easy).
Project Privacy
Access to Protocol Builder needs to be approved by the User Administrator or Contract Owner. User administrator and user access is safeguarded by SSL login access. Further restrictions are available, such as limited IP access, with custom agreements.
Information sharing is user-centric and permission-based: Protocol Owners decide who they want to share information or collaborate with and at what permission level (allows colloborators to either edit or just comment on content). They can also decide to un-share by changing the permission level to none.
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