To be a successful CRO, it is important to be responsive to the needs of sponsors. Ultimately, delivering high-quality results quickly and efficiently. A CDMS/EDC partner can either help or hinder a CRO, depending on its functionality and level of support.
As a CRO known for their excellent customer service, Vanguard Clinical had to act fast to find an equally supportive CDMS/EDC partner to replace a client’s existing system.
Vanguard Clinical has 20+ years of experience managing clinical trials across all phases and various therapeutic areas, specializing in rare disease and early-phase oncology trials. With unwavering integrity, Vanguard Clinical values strong and nimble partnership above all else.
With only five weeks left before First Patient First Visit, Vanguard Clinical recommended Medrio for their client’s needs. In just three days, the development environment was deployed and training was scheduled. According to Tiffany Sepp, CEO and President at Vanguard Clinical, the partnership has been “incredibly productive and positive” ever since.
In our interview with Tiffany and Jamie Parker, Director of Clinical Data Management & Biometrics, learn how Medrio empowers their team by:
- Enabling high-quality, efficient processes through robust functionality
- Accelerating timelines with streamline study builds and mid-study updates
- Providing swift support and effective training
- Ensuring consistent results with an integrated suite of solutions
Easy-to-Use, Robust Functionality Empowers Efficiency
Creating a supportive client environment is important to Vanguard Clinical. So, when selecting technology, ease-of-use and product functionality were top priorities. Among other benefits, choosing Medrio supported a 50% time reduction from point of visit to patient data entry.
When reflecting on Medrio CDMS/EDC, a few of the key features stood out.
- Global user management
- Real-time data access
- Ease-of-use for site data entry
“Medrio’s global user management is smooth. It makes it easy to control user access. Additionally, it allows you to add members, change user roles, and add new roles when needed,” Jamie said.
Plus, the ability to give applicable parties the appropriate real-time data access makes all the difference. Jamie discussed different scenarios, such as statisticians quickly retrieving data after submission, in-house pharmacovigilance only accessing specific forms, and role configurations that prevent accidental unblinding during report generation.
Jamie continued, “Real-time visibility is key—no waiting, no frustrations. Immediate access to data ensures timely decision-making, preventing delays in critical activities such as safety review committee meetings.”
The 50% time reduction from point of visit to patient data entry is mainly because of the ease-of-use for site data entry. Vanguard Clinical reported that previously site data entry would take around five days after a patient visit. Now they are seeing data entry in two to three days post visit.
“We are seeing sites enter data very quickly, which is rare. There hasn’t been any need to retrain on Medrio. Our clients are extremely happy,” said Jamie.
Autonomous Study Builds and Mid-Study Updates Speed Timelines
For Vanguard Clinical, in-house study builds that did not require programming were essential. At the same time, it was important to have study builds that created ease for sites, monitors, data management review, and database lock.
“It’s an all-in-one system—development, test, and production sites in a single location. No need for multiple URLs or query reconstructions,” Jamie emphasized.
With Medrio, Vanguard Clinical found the following functionality incredibly supportive:
- Study builds that do not require coding
- Library features that enable pre-built eCRFs with edit checks, ranges, and skip logic
- Queries that help reduce build time for future studies
- Ability to add images to eCRFs to help with form completion or for imaging studies
- Change request ownership
Because of increased build efficiencies, Vanguard Clinical can now build some studies in as little as two weeks, compared to the industry average of 68 days.
Jamie explained, “Thanks to Medrio, we can expedite the setup of decentralized studies, imaging, some phase I, and potentially phase II studies. By efficiently handling upfront legwork, we can build these studies in two to four weeks.”
Additionally, autonomy over change requests has reduced their timeline to less than five business days for request completion. “We’re doing change requests in record time,” Jamie exclaimed.
Effective Support and Training Drives Results
Swift, effective support began from the start. In only three days from initial contact, Medrio quickly ramped up to meet tight deadlines and keep Vanguard Clinical ’s client on track.
“Less than five weeks before the First Subject First Visit, we determined the current [CDMS/EDC] vendor wasn’t providing the white glove service we wanted. Urgently, I contacted our Medrio representative. Within three days from call to contract, our training was scheduled and the development environment was set up,” explained Jamie.
Vanguard Clinical highlights these key support and training aspects:
- Quick response times that prevent trial delays
- Effective live and recorded trainings that mitigate the need for retraining
- Hands-on support when study challenges arise
- Knowledgeable and supportive team members
According to Vanguard Clinical, the training process was quick and effective. They watched training videos at their own speed, attended live sessions, and built the study all at the same time. This streamline process meant no study build delays for their client.
“Not only is the training quick and effective for study builders, but it’s also fast for sites, monitors, and data managers. The fact that I haven’t had to retrain anyone on Medrio is a result of that,” said Jamie.
After implementation, the ongoing support and responsiveness has been key to a strong partnership, especially when study challenges arise. Jamie added, “Medrio consistently delivers the white glove service we expect for our clients, ensuring same-day responses and support. The [Medrio] team is readily available for any questions or additional information, offering quick and helpful communication.”
An Integrated Suite of Solutions Ensures Consistency
Vanguard Clinical values Mario’s integrated solutions to create a seamless experience for study stakeholders and simplify back-end processes. Currently, Vanguard Clinical has experience using Medrio CDMS/EDC but is actively exploring how other integrated Medrio solutions could impact their trials.
“If you want to add ePRO or eConsent, everything is integrated. We’re good to go,” emphasized Jamie.
A fully integrated suite of solutions also allows for seamless experiences and support. “Important integrated Medrio solutions, like ePRO, eliminate the need for additional vendors. This creates a seamless experience and reliable service for all Medrio offerings,” explains Jamie.
Powerful Partnerships: A Success Story with Medrio CDMS/EDC
When asked about Medrio, Tiffany explained, “Our relationship with Medrio has been incredibly productive and positive. From the initial database build during a crisis with a legacy vendor, Medrio’s quick and effective support showcased their outstanding team. We are grateful for the relationship and anticipate a long and fruitful collaboration ahead.”
In our parting words Jamie shared a few tips from her 20 years of experience for other CROs looking for a CDMS/EDC partner. She suggested looking for a CDMS/EDC partner with:
- Real-time data access for all stakeholders simultaneously in a single system
- Ease of database setup without the need for coding or programming skills
- Dedicated, responsive in-house support team that can help with study builds or other needs
Due to their success with Medrio CDMS/EDC, Vanguard Clinical is exploring other Medrio solutions for future studies, with particular interest in the flexibility of Medrio eConsent.
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 Vanguard Clinical
With over 20 years of industry experience, Vanguard Clinical Inc. is a leader in clinical trial management whether as a CRO or For Service Provider (FSP). Our highly talented and diverse team has the expertise to carry out all phases of trials in many therapeutic areas.
At Vanguard Clinical, we focus each day on consistent delivery of quality and excellence. We are driven by passion and purpose to bring new drugs to market in order to save lives. As a small company, we take a partner-like approach; we are nimble, we are flexible, we are transparent. We believe above all in doing things the right way, the first time around; this unwavering integrity has served as the foundation for relationships with our team and our clients alike.