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Lexi Sharkov06/18/243 min read

A competitive edge: How an eQMS helps CROs & CDMOs stand out to prospects

The markets for Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) are growing. Fast. In the U.S. alone, these two markets are projected to reach $19.75 billion by 2033, up from $10.82 billion in 2023. There are a lot of reasons for the rapid growth, but much of it can be boiled down to increased complexity in drug development. Not only does this push pharma companies to look for cost-effective outsourcing partners, it creates a need for flexibility and scalability in both research and manufacturing – areas where CROs and CDMOs shine.

As the industry expands, CROs and CDMOs face two challenging tasks: 1) scale Quality operations to keep pace with growth and; 2) stand out in a highly competitive landscape.

Luckily, an eQMS can help with both. Here’s how ramping up Quality with an eQMS helps CROs and CDMOs stand out to prospective sponsors and partners. 

Impress with constant audit-readiness

Between regulatory bodies, sponsors, and other Quality-concerned clients, CROs and CDMOs are audited a lot. This makes sense – these customers have a lot of money, time, and risk riding on the performance of their CRO and CDMO partners. And when a client comes to check on their investment, scrambling to find the right paper document or a training file hidden in the depths of Dropbox isn’t the way to win their confidence – or repeat business. 

With an eQMS, the audit process looks fundamentally different. Instead of hours (or days) spent compiling training reports or driving between sites to gather documents, with an eQMS it takes minutes. And not only does it make it easy for Quality leaders to find what they need, it ensures auditors are impressed with what they find. Training management, change control documentation, SOP version control, and more are all made easier with eQMS automations and workflows – helpful when an auditor (or multiple) makes an unexpected visit. 

Remember, you don’t have to get ready if you stay [audit] ready. 

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Show compliance with multiple regulatory frameworks

For CROs with multi-site clinical trials or CDMOs managing production across multiple regions, adherence to international regulatory requirements is non-negotiable. However, each region comes with its own set of complex regulations for clinical trials, manufacturing practices, data protection, and more. Meeting multiple (and constantly evolving) standards on a manual QMS is challenging. 

An eQMS makes it easy to adapt workflows, training, and more to meet new or changing requirements as clients come onboard. No more hunting down every outdated SOP document across each site – just upload the newest version, retire the old, and assign training as needed with just a few clicks. 

With an eQMS that meets GCP and GMP regulations around the world, CROs and CDMOs can prove their operations aren’t just compliant, but consistently monitored and adjusted to stay up-to-date with the latest regulations – a huge plus for clients ready to scale globally. 

Protect the chain of compliance with better vendor management

Though CROs and CDMOs are vendors themselves, their success also hinges on the reliability of the third-party vendors they partner with, like material suppliers or logistics companies. And of course, clients and Sponsors want to know their investment is protected all the way through the vendor chain. 

With an eQMS, CROs and CDMOs can highlight their vendor qualification process, track and report on vendor audits, and quickly showcase an approved, fully vetted vendor list. Your quality management is only as good as the least compliant link in the development chain, and the contract organizations that can prove iron-clad compliance from start to finish quickly get a leg up in a competitive market. 

Showcase quality maturity 

A digital quality management system should be more efficient and secure than a manual one… but there are exceptions. An organization using 10 different software platforms to manage quality will likely face more inconsistencies, errors, and difficulty finding documents than an organization using a single system.

Ever heard the quote “simplicity is the ultimate sophistication”? The more streamlined and efficient your quality management system, the more mature it is. 

A robust eQMS that incorporates training management, documents, change controls and more on one platform helps eliminate tech bloat and proves to clients that your Quality operations are elevated. And best of all, keeping one single source of truth means only one platform to validate. 

Though an eQMS is invaluable to Quality teams in all life sciences organizations, for CROs and CDMOs it’s not just a tool, it’s a competitive advantage. Curious how an eQMS can make a difference at your company? Our team can show you.