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 Verily Viewpoint Site CTMS (formerly SignalPath by Verily).

Site CTMS isn’t your average system. 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 this 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. Compound all of these stressors with increased study
volumes, limited workforce,and turnover. It doesn’t have to be this way.

Through our proprietary 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, Site CTMS powers and propels all clinical and financial workflows
for every consented participant.

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

How does protocol digitization work? 

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

Steps to protocol digitization: 1. Submit your PDF protocol 2. Site CTMS tech and team digitizes your protocol 3. Together, we conduct quality assurance 4. You review and grant final approval

Because of our continued commitment to improvements and innovations, much of the protocol ingestion and configuration occurs within the CTMS software itself. However, Verily’s expert Site CTMS teams also assist to ensure clients receive timely, accurately digitized protocols.

Immediate detailed schedule of events for participants.

Organized calendar view for each study arm

Optimal version control and revision tracking

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 with Site 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.

Value to researchers

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

Operational efficiency drivers:

• Helps reduces manual tasks for start up and conducting studies
• Can limit reliance on sponsors for tools and resources
• Helps eliminate spreadsheets for workflows and logic
• Fosters lower learning curves for launching and running studies

Quality improvement drivers:

• Supports diminished deviations in managing and performing activities
• May prevent revision and versioning issues per one master translation
• Helps ensure 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 books isn’t easy. 

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

In addition, this enhanced alignment uncovers financial pitfalls, such as revealing areas of under- or over-budgeting, which aids 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 

Site CTMS protocol digitization can improve research productivity, quality, affordability and staff retention. These collective values may 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 complexity 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

Site CTMS is an advanced, but easy-to-use, solution that 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 Site CTMS work smarter, not harder; enhancing workstreams to help meet the growing needs of clinical research and boost job satisfaction.

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.

Site CTMS is an advanced, but easy-to-use, solution that 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 Site CTMS work smarter, not harder; enhancing workstreams to help meet the growing needs of clinical research and boost job satisfaction.

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

*Annual compounded rate increase, global market

**Annual compounded rate increase, United States market 

PTO = Paid time off 

Sources

1. Bio-IT World Press Release: Clinical Trials Market Size USD 84.43 Billion by 2030. https://www.bio-itworld.com/pressreleases/2022/07/19/clinical-trials-market-size-usd-84-43-billion-by-2030
2. ACRP Special Report: An Assessment of the Adequacy of the Clinical Research Workforce. https://acrpnet.org/special-report-an-assessment-of-the-adequacy-of-the-clinical-research-workforce