Protocol digitization – What exactly is this transformative CTMS feature?

Clinical research sites feel the weight of this ever expanding, ever evolving field that’s imperative for critical medical and science discoveries. Plus, study teams are burdened by many challenges, complexities, and tedious, time-consuming tasks, such as executing against PDF, or "paper", protocols.

To overcome research demands and gridlock, study sites must adopt an advanced clinical trial management system (CTMS), such as SignalPath by Verily. But SignalPath isn’t your average CTMS. It’s a holistic solution for helping study teams overcome research demands and gridlock with user-friendly features and market-leading innovations, such as protocol digitization.

Protocol digitization is a complex name for a simplifying feature that turns long, complex hard-copied PDF study protocols into intuitive, seamless, and accurate digital workflows.

Read on to learn more about our proprietary protocol – and site – transforming feature.

Clinical trial demand far outweighs the workforce supply

What is protocol digitization? 

Sites are bogged down by the enormous, daunting task of building, running, and analyzing a study as directed by the protocol. And most are executing on these essential tasks by way of a PDF, or “paper” protocol. The expertise, time, effort, and budget required to achieve this is immense, not to mention the mental and morale strain on staff. Then, compound all of these stressors with increased study volumes, limited workforce, and turnover. It doesn’t have to be this way.

With SignalPath, there’s a better way to protocol.

Through our patent-pending protocol digitization function, PDF protocols are accurately and efficiently ingested and digested, turning pages and pages of criteria, logic, steps, and data into a digital master study translation. Once digitized, our CTMS powers and propels all clinical and financial workflows for every consented participant.

Plus, this power extends beyond managing a study’s schedule of events. With SignalPath’s protocol digitization, each study’s schedule of events, inclusion and exclusion criteria, randomization, and other critical information are pre-configured and automated within our CTMS by our tech and teams before a study goes live. In short, it simplifies and it streamlines.

How does protocol digitization work? 

SignalPath’s patent-pending technology and process for protocol digitization is a simple, seamless experience for clients that consists of the following steps.

Also, because of our continued commitment to improvements and innovations, much of the protocol ingestion and configuration occurs within our CTMS software itself. However, our expert teams also assist to ensure clients receive timely, accurate digitized protocols.

Once digitized, clients can easily view, manage, and adjust studies, including elevated, organized views of activity schedules and more

How is protocol digitization valuable?

Because protocol digitization is a comprehensive digital translation of a study protocol, its value transcends helping coordinators and clinical staff successfully execute intended procedures and activities, such as providing the pre, during, and post steps to fully facilitate participant visits (although it provides this key feature, too).

Protocol digitization within SignalPath’s CTMS adds value – from process improvements to research quality to actual monetary value and more – for all study stakeholders, aiding researchers, financial teams, and site leadership.

Protocol digitization is also a standard SignalPath feature, which means all users reap the benefits

Value to researchers  

When asked what fuels most researchers, many will say the research itself—the potential of new findings and crucial questions finally answered. Protocol digitization supports a streamlined, simplified path to discovery that improves research quality and therefore, researcher confidence.

Operational efficiency drivers:

Reduces manual tasks for start up and conducting studies

Limits reliance on sponsors for tools and resources

Eliminates spreadsheets for workflows and logic

Lowers the learning curve for launching and running studies

Quality improvement drivers:

Diminishes deviations in managing and performing activities

Prevents revision and versioning issues per one master translation

Ensures operational continuity, especially with staff changes or PTO

Value to finance teams 

Even though sponsors pay study sites to conduct clinical trials and research, budgeting is essential to mitigate financial waste and misuse. However, balancing the books isn’t easy.

Through building of a single, easy-to-navigate translation, protocol digitization enables a clearer picture of study coordination costs and its true monetary implications for sites; aligning research and finance teams to more effectively analyze financials and plan budgets.

Once translated, budgets are more effectively analyzed and more easily projected

In addition, this enhanced alignment uncovers financial pitfalls, such as revealing areas of under- or over-budgeting, which aids both teams, especially for budget negotiations of future studies. For example, researchers may identify an unmatched budget for the schedule of events, leading to inadequate reimbursement. This learning informs more precise planning to better support the site’s research-related financial competency going forward.

Value to leadership 

Protocol digitization via SignalPath’s platform improves research productivity, quality, affordability, and staff retention. These collective values ladder up to the leadership level, supporting more productive relationships with sponsors and enabling more educated executive decisions, such as taking on additional trials or expanding research capabilities.

Here's how:

Staff retention: It’s worth repeating that taking protocol configuration tasks out of scope can reduce staff burden and repetitive tasks that often lead to turnover.

Cost containment: Sites limit cost-incurring, additional hires or consultants for manually building workflows into other CTMS software.

Risks reduction: Again, through centralizing activities and procedures, protocol deviations that may potentiate risks, errors, and waste are diminished.

Ops improvement: Lastly, pre-configured workflows facilitate quicker study launches, faster staff onboarding, and easier coverage for leave or vacations.

A better way to protocol 

As the volume and complexities of research increases, study sites must rely even more on innovative technologies to alleviate pain points that slow down studies, drive away talent, increase costs, threaten output, and more. But some tech doesn’t deliver on its promises.

SignalPath is an advanced, but easy-to-use, CTMS solution that actually performs as promised. And it’s the ONLY CTMS with next-generation protocol digitization technology.

Instead of hiring new employees or burdening existing staff with onerous tasks, like operating against PDF protocols, clients who leverage SignalPath work smarter, not harder; enhancing workstreams to help meet the growing needs of clinical research and boost job satisfaction.

Experience the innovation

View protocol digitization in action. Request a guided demo of this transformative feature.