As the complexity of clinical trial protocols increases and regulatory requirements continue to evolve, choosing the right technology provider to support early phase trials becomes increasingly challenging.
For MAC Clinical Research, one of Europe’s largest Contract Research Organizations (CRO) running full-service global clinical trials for many of the world’s leading pharmaceutical and biotech companies, the challenge was no different.
MAC excels in complex and scientifically challenging first-in-human (FIH) and early phase clinical trials, with extensive expertise within the central nervous system (CNS), especially cognitive disorders, dementias, and pain research. They also offer specialized psychedelic testing facilities and have expanded their expertise to cover a wide range of therapeutic areas.
With their expanded expertise covering a wide range of therapeutic areas, MAC needed a reliable technology partner to support their clinical trials. Ultimately, MAC selected Medrio as their sole CDMS/EDC provider for their clinical trials. They developed standard libraries that streamline the study build process, allowing them to aim for a 12-week build time, even in the face of trial complexities.
In our interview with Hannah Gillis, Head of Data Management at MAC Clinical Research, learn how Medrio supports MAC’s early phase clinical trials by:
- Providing unmatched customer support and expert guidance
- Supporting complex protocols to accelerate study timelines
- Enabling efficient study builds
- Ensuring compliance with regulatory guidances
Unparalleled Customer Support and Expert Guidance
At Medrio, we aim to be a partner, not just a vendor. MAC felt this customer-centric commitment through our knowledgeable team of subject matter experts (SMEs), detailed protocol reviews, personalized training, and responsive customer support. This personalized support ecosystem helps keep studies on track without delays.
Hannah emphasizes, “Medrio sets itself apart through its exemplary customer care and support, establishing a genuine working partnership. The quality of both training and support services is outstanding. There is always someone available, assuring us that we are not alone.”
Plus, as the study progresses, “The support center consistently delivers exceptional responses. Medrio ensures all issues are swiftly addressed and followed through to completion.” Hannah continues, “Medrio stands out as a customer-centric enterprise that provides unwavering support to their customers.”
Supporting Complex Protocols to Accelerate Study Timelines
MAC often conducts complicated studies with complex protocols and many cohorts that require different workflows across multiple sites. Medrio CDMS/EDC functionality and the study build process help MAC to efficiently set up trials, manage clinical data, and meet trial deadlines.
Hannah explains, “I would definitely recommend Medrio for early phase studies because the complexity of the protocols can be managed very well.”
All of MAC’s research site users enter data through Medrio electronic case report forms (eCRFs). The process then shifts to MAC, who manages this electronic data in Medrio. The efficiency of this process has helped MAC meet trial timelines, even achieving database lock in advance of set deadlines.
“Medrio facilitates a controlled and easily manageable process. Studies have been successfully locked ahead of the targeted timeline due to the completion of all tasks well in advance,” says Hannah.
Facilitating Efficient Study Builds
Medrio has enabled MAC to target 12-week study builds, despite the complexity of their trials. Standard libraries and the ability to copy previous study builds and eCRFs help create an efficient study build process.
Hannah emphasizes, “The ease of build and the ability to reuse previous studies and eCRFs is remarkable. How we run the build and arrange groupings with the eCRF are also very well supported within Medrio.”
MAC also leverages Medrio’s testing environment provided to all customers to build and test eCRFs and custom queries. Plus, creating custom user roles with designated permissions allows MAC to easily grant access to appropriate parties without concern.
“We have a user permissions matrix that goes down to the form level. We set up the matrix for every user of each role. It’s great and provides a very nice level of control. Each role can have very specific, read, write, blinded, and edit access to each particular form. We can easily and quickly accommodate requests for specific levels of access from external medical monitors within Medrio due to the role-building capabilities,” explains Hannah.
Maintaining Regulatory Compliance
New regulatory guidances, like ICH E6 R3 and EMA Computer System Guidelines, continue to emphasize requirements for investigator signatures on investigative oversight. MAC is confident that Medrio’s functionality will relieve sponsors’ concerns regarding these guidelines.
“With the new ICH E6 R3 and EMA Computer System Guidelines in Clinical Trials, there’s a strong industry push to enforce investigator signatures more often. I’ve been quite surprised at how people using other systems have said that their systems won’t be able to support this. Medrio’s functionality can easily support this requirement, making it a great solution,” explains Hannah.
Regarding investigative oversight mentioned in ICH E6 R3 guidelines, Hannah says, “Within Medrio, this is completely doable. Medrio’s standard functionality makes setting up the configuration nice and easy.”
Successfully Empowering Complex Early Phase Trials
MAC Clinical Research’s partnership with Medrio represents a successful collaboration in overcoming the complexities of early phase trials with an effective CDMS/EDC solution and unmatched customer support.
As MAC expands into later phase studies, they are actively learning how Medrio can further support their growth and how other Medrio solutions, like eCOA/ePRO and eConsent, can create more efficiencies within their trials.
To learn more about how Medrio can support your early-phase studies, connect with Medrio here.
About MAC Clinical Research
MAC Clinical Research is one of Europe’s largest Contract Research Organizations (CRO) with headquarters in the UK. MAC is committed to the conduct of full-service global clinical trials for many of the world’s leading pharmaceutical and biotech companies.
MAC has extensive experience in First-Time-in-Human (FTIH) studies. Their experience is largely focused in conducting trials for central nervous system (CNS) conditions, cognitive disorders, dementias like Alzheimer’s Disease, and pain-related research. They also maintain dedicated research facilities for psychedelic testing and have diversified their capabilities into various other therapeutic areas, offering their expertise in a wide range of research fields.
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.