The Top 3 Reasons Your Central Lab's E-Requisition Forms Fall Short
Requisition forms were originally designed to serve one critical purpose: to transmit sample metadata between sites and labs.
Unfortunately, they’ve failed to keep up with the pace of today’s trials. Especially in studies involving multiple labs and clinical systems like the EDC, advanced specimen processing, and cross-functional research site teams, these forms are more of a bottleneck than a solution.
At face value, many sponsors may see lab-specific e-requisitions (e-reqs) as an innovation over the paper requisitions that have dominated biospecimen management for the last several decades. But upon closer examination, there’s more to e-reqs than meets the eye.
Here are the top three reasons why your central lab's e-requisition forms aren’t a sufficient solution to many of the problems that paper requisitions have also presented — and what sponsors should consider as they evaluate a path forward.
1. They don’t connect with other labs or EDC
E-req forms are inherently lab-centric. They’re designed to streamline operations for that specific lab — not for the broader biospecimen ecosystem. This might work in theory for simple, single-lab trials, but it breaks down in today’s more common multi-lab environments.
Clinical trials now frequently involve a central lab and/or multiple specialty labs, along with the EDC. Yet, e-req forms often exist in isolation, siloed within each lab’s proprietary portal. This leads to:
- Redundant data entry across systems and portals
- Inconsistent or duplicative data between e-reqs and the EDC that eventually has to be reconciled
- Delays in reconciliation and increased risk to sample availability for analysis and reporting due to data discrepancies
Ultimately, lab-centric e-req forms are a band-aid solution in a world that requires interoperability.
Join us on June 17th for “The Future of Requisition Forms”, a live webinar unpacking today’s biggest challenges — and opportunities — from the perspectives of sponsors, sites, and labs. We’ll explore a better path forward for the entire clinical trial ecosystem.
2. They are not site-friendly
In a world where trials are more complex than ever, sponsors should be doing everything they can to ease the burden on sites while supporting their ability to be compliant with sample management — but most lab-specific e-req forms only make their jobs harder.
Site staff are already stretched thin, and the proliferation of disconnected systems doesn’t help. Juggling multiple lab portals, logins, EDCs, and training requirements increases both their cognitive burden and the chances of error. E-req forms also often don’t accommodate real-world workflows like role-based handoffs between different site staff, or study-specific needs like PBMC and tissue processing.
Every trial already comes with its own learning curve, and sites bear the brunt of it. When requisition workflows are fragmented and overly rigid, they continue to slow down sample management, increase protocol deviations, and ultimately frustrate sites — leading to issues with data integrity and protocol adherence.
3. They aren’t a holistic solution for ICH E6(R3) compliance or end-to-end biospecimen management
The new ICH E6(R3) guidance is a wake-up call for sponsors: biospecimens are now considered part of the essential record. That means you must be able to demonstrate end-to-end chain of custody — from the moment a sample is collected at the site through retention or destruction.
Lab-centric e-req forms don’t deliver on this mandate. They’re narrow in scope and fail to provide the unified oversight needed for risk-based quality management across the entire biospecimen lifecycle. Key shortcomings include:
- No visibility into activities at the site
- No harmonized audit trail across multiple labs
- Limited to no proactive risk mitigation features
Sponsors are also now expected to have increased oversight responsibilities, which can’t be met by relying on disparate lab systems alone. Without a more holistic approach to biospecimen management, you’re not just dealing with inefficiencies — you’re opening yourself up to compliance risks and compromised data integrity.
The way forward: Modernize your biospecimen workflows
The biospecimen management ecosystem is more complex than ever before. Your approach to requisition workflows must evolve accordingly. That means avoiding lab-specific e-req forms or augmenting them with a more holistic solution that:
- Harmonizes sample metadata across all labs and EDC
- Supports site staff with intuitive, flexible tools that reduce their burden and improve their compliance
- Enables end-to-end sample oversight, audit readiness, and proactive risk mitigation per ICH E6(R3)
Next steps:
- Join us for our upcoming webinar on June 17th, “The Future of Requisition Forms”, where we’ll explore requisition processes from the sponsor, site, and lab perspective.
- Check out our interactive guide, "Requisition Workflows Reimagined." It’s packed with actionable insights on how to move beyond outdated requisition processes and modernize a key workflow in your biospecimen operations.
