Contributing experts: Rod McGlashing, Data Science Subject Matter Expert at Medrio
Rescue studies can happen for a variety of reasons including a communication breakdown, slow enrollment, or an underperforming vendor.
Regardless of why a study is at risk, sponsors and CROs need help getting it back on track as quickly as possible. They need a partner who can step in, restore order, and, most importantly, protect data integrity.
Rescue studies require a complete database migration and a full rebuild in the new EDC. Medrio’s technology and team were built to handle exactly these kinds of high-pressure situations, protecting both data and timelines.
In this guide, we’ll explore:
- How Medrio approaches rescue studies
- What capabilities to look for when transitioning between EDC vendors
- What best practices to follow when switching systems
Ready to make the switch to Medrio? Book a demo today.
How Medrio approaches rescue studies
After shepherding many rescue studies to safety, the Medrio team has developed a structured approach. Our aim is to bring order to chaos.
Medrio’s methodical approach includes:
- Triage and assessment: Review data and workflows while isolating failure points.
- Rebuilding and optimization: Redesign eCRFs, rules, and edit checks to align with standards.
- Data intake and mapping: Define the migration plan, field mapping, and QC strategy.
- Stabilization and progress: Resume clean operations and reporting cadence for study completion.
- Import and validation: Run controlled imports, SAS QC, and resolve discrepancies.
Once these steps are complete, the Medrio team can stabilize and advance the study on a solid foundation.
Why Medrio is the right choice for your rescue study
Sponsors and CROs facing a failing study need a partner with deep expertise to get their trial back on track. They need an experienced team with a structured process to protect data quality while ensuring stability and compliance.
Here’s why companies trust Medrio to rescue their study.
| Capability | Medrio | Enterprise Vendor |
|---|---|---|
| EDC configurability | Guided autonomy with no-code, point-and-click configuration, forms, edit checks, and workflows. | Highly configurable but typically dependent on coding knowledge, plus certified builders or professional services for modifications. |
| Compliance | Aligns with rigorous compliance standards, including hands-on guidance during transitions. | Compliant system with service layers that can slow execution during time-sensitive rescues. |
| Customer support | Responsive 24/7 global technical support with most tickets resolved within minutes. | Impersonal support with slower response times, especially for smaller customers. |
| Pricing | Predictable cost during study transitions based on transparent pricing. | Opaque pricing models with modular licensing, service fees, and potential unexpected costs. |
Configurable, no-code EDC
A nimble EDC gives internal teams the ability to build and adapt studies without heavy reliance on vendor services. With an easy-to-configure EDC, teams can respond quickly to protocol updates.
At Medrio, minor changes do not require extended service engagements or complex rebuilds. Medrio’s EDC reduces handoffs and shortens build cycles with no-code, point-and-click configuration, forms, edit checks, and workflows. That autonomy allows sponsors to get a study back on track more efficiently.
Enterprise-grade compliance
Regulatory readiness is non-negotiable, but it doesn’t require a large enterprise solution to achieve. Medrio’s EDC supports rigorous compliance standards while maintaining ease of use. Clean data capture and streamlined workflows reduce risk as a study transitions from another vendor.
Medrio combines compliant infrastructure with guided autonomy. Study teams retain control and don’t need to sacrifice oversight. That balance allows emerging sponsors to execute with confidence and speed. By supporting both compliance and agility, Medrio reduces long-term risk for its users.
Read more in our How Medrio Protects Your Clinical Trial Data article.
Responsive support
A rescue study requires responsive support to get things back on track fast. When questions arise about anything from functionality to billing, your team needs answers quickly. Delayed support can stall momentum and distract from core clinical priorities.
A nimble EDC provider pairs technology with accessible expertise. At Medrio, customers receive 24/7 global technical support with fast initial response and resolution times. That level of engagement ensures issues are addressed before they impact milestones.
Medrio maintains a 98% customer retention rate, reflecting long-term client satisfaction. A high percentage of support tickets are resolved within minutes, keeping study timelines on track. This hands-on approach helps customers feel supported rather than overlooked.
“Not only did [Merdio] help us get back on track in the original timelines, we actually opened it earlier than we thought we were going to.” —Katrina Hodson, KLH Consulting, regarding Medrio’s support during a rescue study
Transparent pricing
Financial predictability is essential as a study transitions from one vendor to another. A nimble EDC offers transparent pricing designed to minimize surprises. Sponsors gain clarity on costs from the outset, reducing mid-study budget strain.
Predictable pricing structures lower the total cost of ownership. At Medrio, routine updates do not trigger unexpected fees, so financial planning becomes more reliable. This stability is especially important as companies navigate a rescue study, which may mean extending timelines while managing investor capital and runway.
Medrio offers a nimble platform that delivers enterprise-grade compliance while remaining cost-effective. This approach allows sponsors to invest more resources in science and patient engagement rather than system overhead.
Rescue study best practices
When transitioning a study from one EDC to another, careful planning preserves data integrity and traceability. The core principles remain consistent across all systems.
Best practices include:
– Building and approving the new database before importing data
– Exporting clinical data in a usable format
– Performing any required transformation before import
– Importing into a dedicated test environment where mappings and transformations can be validated through structured comparisons.
– Carefully reestablishing randomization controls in production.
– Making considerations for upstream dataflows, such as third-party data coming in via APIs
– Managing downstream data flows, including data shared with other modules such as CTMS, analytic databases, or vendor/sponsor databases.
– Exporting and archiving test data as part of the validation package
– Preserving traceable records, data review workflows, queries, and integrations.
Reminders:
– Only clinical CRF data is transferred during a rescue.
– Metadata, audit logs, and monitoring documentation should be archived in the eTMF to maintain full traceability.
– Clear SOPs and compliance oversight are also essential throughout the transition process.
Leveraging Medrio’s Clinical Data Services for a rescue study
When a study is in jeopardy, Medrio’s Clinical Data Services (CDS) team is here to help you streamline the entire clinical data capture and analysis process.
Our team has experience in rescue studies and can help you maintain data integrity and move quickly to get your study back on track.
At Medrio, our CDS services include:
- Electronic Case Report Form (eCRF) and database build services
- Comprehensive data management services
- Biostatistics and statistical programming
Medrio’s Clinical Data Services include a team of highly experienced professionals. Our experts bring nearly 300 years of combined industry experience across clinical data management, programming, and biostatistics.
All CDS activities are governed by Medrio’s comprehensive, audit-approved SOP framework. This process has been highly rated by multiple independent and sponsor audits.
Every step—from database build to database lock—is performed with the highest level of quality, traceability, and compliance to support a successful rescue study.
Supporting rescue studies with a responsive solution
When faced with a rescue study, sponsors and CROs need an experienced partner who can get things back on track quickly and protect data integrity.
Medrio’s EDC enables faster builds, responsive support, predictable costs, and confident compliance. The Medrio team brings deep experience and expertise to the rescue study process and is ready to help.
Ready to make the switch to Medrio? Book a demo today.
