Contributing Experts at DP Clinical: Matthew Jachowski, Senior Technical Clinical Data Manager, and Jim Hamer, Director of the Spinal Cord Injury Program
Without the right clinical trial technologies, study timelines, participant experiences, and sponsor satisfaction can suffer.
Tasked with executing an observational trial in spinal cord injury patients, DP Clinical faced the challenge of managing diverse data collection and informed consent processes for a participant population with limited mobility.
With 25 years as a CRO, DP Clinical understood that to be successful, they needed flexible data capture solutions and clinical data management support. That’s when the DP Clinical team turned to Medrio, who they have trusted with more than 22 studies for over eight years.
To better understand their story, we interviewed Matthew Jachowski, Senior Technical Clinical Data Manager, and Jim Hamer, Director of the Spinal Cord Injury Program.
Learn how Medrio supported DP Clinical to:
- Streamline trial operations
- Improve participant experiences
- Drive sponsor awareness
- Accelerate study timelines
Empower your trials with Medrio by connecting with our team.
Efficient eClinical Technology Streamlines Trial Operations
DP Clinical prioritized trial efficiency while running a complex trial that captured data in multiple settings. They needed flexible, easy-to-use technology for streamlined clinical operations.
Medrio supported efficient operations with:
- Intuitive builds with drag-and-drop features
- Pre-built form libraries and templates
- Three-tiered production and validation environments
- In-clinic, remote, and hybrid data collection
- Comprehensive reporting capabilities
“The programming is just so easy. Edit checks can be a tricky thing for any data manager to program. With Medrio’s drag-and-drop interface, it makes it so simple,” said Matthew.
The drag-and-drop interface made building a database straightforward.
Additionally, the ability to build and reuse a library of forms, edit checks, and queries supported faster and more consistent study setups. For example, the DP Clinical team built the Columbia-Suicide Severity Rating Scale (CSSRS) into their template library, which they can reuse across multiple studies with prior approval from the licensor.
“A library of forms that includes edit checks, queries, and export value names allows us to quickly implement while ensuring consistency across studies,” explains Matthew. “Once the biostat team reviews and approves these templates, we have an SDTM-compliant setup ready to use in any study, significantly reducing build times.”
Plus the three-tiered production and validation environments facilitated efficient testing and implementation of database changes required by protocol amendments. This approach ensured they could validate all changes before going live, maintaining data integrity and minimizing study disruptions.
“Medrio’s validation environment has been invaluable,” adds Matthew. “We can test changes in a mirrored live environment, anticipate the impact on live data, and ensure seamless transitions.”
Flexible eConsent and ePRO Solutions Improve the Participant Experience
With a unique participant population, patient-facing technology must be user-friendly and have the ability to adapt to different preferences.
Medrio’s ePRO and eConsent solutions provided a positive participant experience, accurate data collection, and high patient usability and compliance.
DP Clinical found the most benefit from:
- Patient usability testing
- Flexible consenting options, including electronic or paper upload
- Tailored ePRO questionnaires and remote completion options
- Email reminders for participants to complete ePRO entries
- eConsent and ePRO builds provided through Medrio services
Medrio eCOA/ePRO enabled remote completion of questionnaires tailored to patients with mobility issues. The ability to customize ePRO for a better patient experience—including breaking down large questionnaires into smaller, digestible parts—improved data collection and patient satisfaction.
“When you’re a patient user—especially one with mobility challenges—having everything crammed into one screen doesn’t work well,” says Jim. “We limited the amount of questions that would appear on each page. Rather than having one page with 30 questions, it was 15 pages with two questions each.”
DP Clinical also replicated licensed assessments accurately while considering the participant experience. This ability helped them maintain the needed formatting and structure of the original assessments to meet licensing requirements.
Robust Reporting Drives Sponsor Awareness
During any clinical trial, sponsors must stay informed about the study’s progress through transparent communication. Medrio’s robust reporting, user-friendly features, and comprehensive support empowered DP Clinical to achieve these goals.
“With Medrio, I’m able to show [sponsors] all of the building blocks in a digestible way,” says Matthew. “Medrio shows all of the pieces that go into each of the specific data points, variables, export values, codes, and lists.”
The features and functionality that most stood out were:
- Three-tiered software environment (build, test, production)
- Robust reporting capabilities for real-time data visibility
- Advanced reporting for Clinician-Reported Outcomes (ClinRO) data
Using Medrio’s three-tiered software environment, DP Clinical supplied the sponsor with complete transparency during the study build. This feature ensured the sponsor could review and understand all database components, fostering trust through clear communication.
Once the trial started, DP Clinical needed to provide the sponsor with accurate and timely study updates for informed decision-making. They leveraged advanced reporting features to produce the precise information the sponsor required without delays.
“I’m able to get things that the sponsor wants directly from the system itself,” reports Matthew.
With the advanced reporting functionality, DP Clinical also developed custom reports to provide the sponsor with accurate source data verification progress on ClinRO. This level of detail provided clarity on trial progress and grew the sponsor’s confidence in the data.
Expert Support and Services Accelerate Trials
With new tools or complex trials, dedicated support and shared knowledge from a technology partner can accelerate timelines, benefit future studies, and result in higher-quality data.
“Medrio never feels like they gatekeep anything. Medrio has always been willing to share knowledge and support our team,” said Matthew.
DP Clinical found significant value in Medrio’s ability to offer support at various levels while matching both the study’s needs and their team’s expertise.
Medrio’s Clinical Data Services team provided :
- Expert guidance and training
- Collaborative eConsent and ePRO build processes
- Dedicated project management
- Responsive and reliable support
DP Clinical also benefited from a dedicated project manager. Ongoing support and coordination helped ensure clear communication and streamline processes.
By leveraging Medrio to build complex eConsent modules, DP Clinical could meet tight timelines and focus on other critical aspects of the study. This partnership enabled DP Clinical to deliver high-quality service and accelerate their clinical trial timelines, ultimately driving successful outcomes for their studies.
Ready for Your Next Research Breakthrough?
High-achieving CROs need robust, flexible clinical trial technology partners who can meet their standards and support their customers. DP Clinical found that partner in Medrio.
Through comprehensive services and solutions, DP Clinical found success in collecting reliable data, streamlining trial operations, improving participant experiences, driving sponsor satisfaction, and accelerating study timelines.
Learn about how Medrio can empower your trials by connecting with our team. Request a demo today.
About the Study
The purpose of this study was to gather quality-of-life and self-care ability data for a cross-study analysis with another ongoing trial.
The study was:
- An observational, questionnaire-based study
- Spread across 12 sites in the United States
- Without any drug or intervention
- Designed to monitor people with chronic spinal cord injuries
The data collection workflow incorporated a combination of remote and in-clinic questionnaires with patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs) as the data endpoints.
The main challenges included:
- Managing remote and in-clinic data collection
- Ensuring the usability of ePRO for patients with limited mobility
- Implementing and managing remote consent and paper uploads
About Medrio
Trusted by sponsors, CROs, and sites worldwide, Medrio aims to improve 100 million lives through faster, more efficient, and secure clinical trials. With almost two decades of experience, Medrio delivers proven, scalable solutions, unrivaled customer support, and guidance to the industry’s leading innovators, including pharmaceutical, biotech, medical device, diagnostics, and more.
Our suite of solutions, including CDMS/EDC, eCOA/ePRO, eConsent, and RTSM, enables the capture of quality clinical trial data while optimizing workflows for regulatory readiness. Experience the power of Medrio and realize the full potential of your clinical operations and outcomes.
About DP Clinical
DP Clinical, Inc. is a privately held Contract Research Organization (CRO) specializing in dermatology, infectious disease/vaccine, neuroscience (including spinal cord injury), oncology, and ophthalmology, Phase I-III clinical programs.
DP Clinical provides a full complement of clinical trial services to pharmaceutical, biotech, and medical device companies, including trial management, monitoring, data management, biostatistics, regulatory, safety monitoring and reporting, and medical writing. Since 1994, we have worked for clients of all sizes — small to large pharmaceutical and biotech companies, academic research institutions, and government sponsors.
