How a clinical software team aces over 50 audits a year
eClinical Solutions provides a cloud-based clinical data software platform which makes truly digital clinical trials possible.
The eClinical Solutions team empowers its clients in the clinical trial space with sharper insights and complete visibility of their trial journeys, from clinical analytics and biostatistics to data control.
The company's work in the industry demands compliance with a wide range of standards, including FDA, EMEA and PMDA requirements. Information security, electronic record and e-signature considerations, such as ISO 27001, SOC 2 and FDA 21 CFR Part 11, are also crucial.
eClinical could get by with a paper-based quality management system while they were still a small, single-site operation.
Things began to change as the company expanded its growth (including its India operations), widened its hiring radius and embraced more remote work, and as COVID-19 arrived.
The company moved to a trial master file-based content management platform but found it lacked the extra QMS functionality they needed, such as CAPA and training management.
Our teams were having trouble being to see everything and link everything.
Using an SOP and looking for its corresponding work instruction, form and template meant 15 different steps.
Our audit tracking and trending was all manual.
We have a small QA team and managing all that in Excel wasn't scalable at all.
It was clear eClinical needed a holistic, purpose-built eQMS.
VP of Quality & Compliance Evan Grunbaum and his team started to search for a tool which would eliminate their manual ceiling and free up the company to scale.
The team were immediately drawn to the intuitiveness and ease of use offered by Qualio.
Evan could access the company QMS at a glance and drill into a web of connected quality information in seconds.
Internal Training Manager Aminah Brelvi knew the system would be easy for new hires to grasp, with functionality like Qualio's Training Overview providing snapshot visibility of company compliance.
And QA Manager Angel Baez Vega could use electronic system workflows to manage quality events to completion and continuously improve the company's operation.
I do new hire training every week.
When I walk them through Qualio, it's so seamless compared to our old QMS.
When I show them the tags and filters, there's a huge excitement.
With its balance of functionality, price and ease of use, Qualio was selected as eClinical's new eQMS, and the team went live in late 2021.
Qualio gave eClinical Solutions an integrated, high-quality approach they can stand behind.
The team face over 50 audits a year from customers, as well as ad hoc quality information requests from customers and prospects.
Sharing access to their old QMS was a complex process of shared logins and SSO quirks. They can now offer instant access to a Qualio library of 325 controlled documents, confident in the system's availability and ease of use.
Acceleration of document access, training and event close-out time have all allowed the company to grow into a stronger, sharper quality approach.
Best of all, that more efficient quality system pays for itself: the team estimate 3 or 4 FTE salaries have been mitigated by their Qualio adoption, delivering significant return on investment.
Headcount has grown by 25%, with 100 new Qualio users onboarded in a year - and, as expected, Evan was pleased to see stellar internal engagement with no complaints or resistance to the system.
eClinical is now poised to expand into Europe and beyond, tackling fresh regulations and satisfying new customers with confidence and control.
.png?width=20&height=20&name=Icons_Newsletters%20(3).png){kind=icon}
