How a Clinical Research Organization (CRO) successfully implemented Digital Transformation and Cybersecurity strategy

To simplify workflow and implement FDA regulatory compliant safe and secure clinical platforms to save time and reduce cost. The system would ideally have seamless collaboration capabilities and standardized processes, while remaining compliant and keeping data secure. Specifically, they wanted an efficient clinical operation workflow that included document management and tracking, automation, collaboration, communications, and software integration within the local and multinational regulatory frameworks.

About Promedica International (PMI)

The Company: A Clinical Research Organization (CRO) with experience in trial design and data analysis across a broad range of medical specialties and therapeutic areas. They strive to make their clients’ participation in medical research a secure, positive experience by providing support for each stage of the clinical study process — before, during, and post-study.

The Goal: To simplify workflow and implement FDA regulatory compliant safe and secure clinical platforms to save time and reduce cost. The system would ideally have seamless collaboration capabilities and standardized processes while remaining compliant and keeping data secure. Specifically, they wanted an efficient clinical operations workflow that included document management and tracking, automation, collaboration, communications, and software integration within the local and multinational regulatory frameworks.

About

Company

Challenges

A small company with limited resources .The team members were working with outdated software and IT systems that were redundant and required manual data input. This not only wasted time, but also increased chances of error, cyber threats and missed deadlines.

They implemented new standard operating procedures and cybersecurity guidelines in the past, but it created more confusion, opening up for higher vulnerabilities. As a result, it ended up taking more time by adding redundant steps to the workflow.

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Our Solution

The Ribera Solutions team provided a sprint-by-sprint process to develop a customized workflow, execute cybersecurity testing, and provide system wide recommendations.


Discovery research: Interviews with the staff to identify pain points, data analysis and insight report, evaluated current workflow processes and digital systems, and reviewed regulatory requirements.


Gap analysis and Governance: A comparison of current performance with the desired outcome and establishing a plan to reach the goals by closing the existing gaps. Implement standard operating procedures to mitigate risks.


System selection: A list of potential solutions with different vendors, attended vendor demonstrations and received pricing, collected customer satisfaction surveys, and finalized recommended systems.


Testing: User feedback interviews and analysis, key outcome report, final decision to proceed or not to proceed with selected system.


Rollout and Training: Step-by-step instructions and hands-on training to assist the team with applying the new operations to their workflow process.


Implementation: Follow-through until the new system is completely operational and the entire team has the training they need to utilize the system successfully

Results of this Endeavour

Significant Cost Savings

As a part of PMI’s digital transformation strategy, this is an ongoing, long-term project. They noticed immediate improvements to their workflow by choosing efficient systems such as; 21 CFR Part-11 compliant e-signature platform, HIPAA and GDPR compliance, GxP and FDA cybersecurity compliance, which translated to 60% in cost savings, improved security and workflow satisfaction.

Improved Security and Compliance

The team has been trained on how to use the new systems. More recently, they completed the evaluation of workflow integration between clinical and business systems, and through that, identified a better collaborative tool (between sponsors and sites) than the existing one and are waiting for validation before implementing the process

Enhanced Workflow Satisfaction

Some of the clinical solutions evaluated were Clinical Trial Management Systems (CTMS), eSource, ePRO, eQMS, eTMF and Patient Recruitment/Engagement platforms

Testimonial

Shannon Stoddard, MBA, CCRA - President/CEO

“I’ve definitely enjoyed working with Abish and his team. I feel that they listened to our problems and came up with solutions. I appreciate the reminders and keeping the projects going. Being a small company, we get busy and sometimes need to be prodded to schedule meetings and make the decisions. Also, I think it’s always hard when you’re coming in from the outside, trying to understand what we do and how things work. And I appreciated the team’s work in doing that. Overall, I think we work well collaboratively.”

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