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Zydus Therapeutics

How this scaling pharma company supercharged their trial documentation processes with eTMF Connect

About company

Champion
Pankaj Patel
Company size
50+ employees
Favourite Feature
Montrium RIM
Key Achievements
80% improvement in trial oversight

Overview

Embracing a new chapter with open arms

With a growing team and an increasing number of important studies in the pipeline, Zydus Therapeutics realized that it was time to implement an eTMF software able to keep up with their complex needs. Driven by a desire to provide the best experience for employees and clinical trial stakeholders alike, Zydus Therapeutics selected Montrium’s eTMF Connect to serve as its supercharged in-house document management solution. Since rolling out eTMF Connect in February 2021, Zydus Therapeutics has been delighted by the powerful features and significant benefits that the system has to offer, helping to improve efficiency and collaboration across the board.

Background

Saving time to focus on what’s important

Customer: Zydus Therapeutics is involved in drug research and development. To support its growing pipeline and global reach, Zydus Therapeutics has been scaling its clinical team to meet its ambitious objectives.

Challenge: The features provided in previous eTMF solutions were no longer a good fit for Zydus Therapeutics. They wanted to find a system that could assist in performing routine functions with ease, and one which allowed them to reinvest time and resources back into their clinical operations.

Solution: Adopting Montrium’s eTMF Connect helped Zydus Therapeutics maximize efficiency and minimize points of friction in their TMF management processes. eTMF Connect has notably improved oversight, productivity, and collaboration in the clinical operations team. Moreover, Zydus Therapeutics has been very pleased with the support they’ve received from the Montrium team throughout the implementation process and beyond.

Challenge

Leveraging experience to support growth

After experiencing challenges with prior vendors, Zydus Therapeutics chose to partner with Montrium.

“We knew Montrium could provide us with the tools that we need and we’re confident that the guidance we receive will keep us on the right path.” - Kimberly Swint, Manager of Clinical Trials Documentation at Zydus Therapeutics.

With eTMF Connect, Zydus Therapeutics knew they had found an eTMF system with capabilities that matched their growth and productivity ambitions, backed by a team that could support them every step of the way.

We have been extremely pleased with the guidance that we are being provided. We understood that it would be very important for us to find a platform that could grow with us as we progressed into Phase III.

Kimberly Swint

Manager of Clinical Trials Documentation

Solution

Striking a balance between powerful and user-friendly

Zydus Therapeutics knew they needed to find an eTMF vendor with not only a powerful platform, but also with extensive industry knowledge to help them along their journey of scaling. Montrium is providing Zydus Therapeutics both the user-friendly, feature-packed software they were looking for, as well as the in-house expertise to back it up.

“We wanted to find a vendor that could provide us with their expertise so that we could utilize it and build our programs the way we needed to,” stated Kimberly Swint, Manager of Clinical Trials Documentation at Zydus Therapeutics.

“We felt that it was very important for the vendor to understand their own product and how it would be useful in this industry.”

With eTMF Connect, Zydus Therapeutics has been able to take advantage of a host of functionalities that are improving efficiency and collaboration, including a convenient staging area, helpful auto-populating features, inbound QC functions, and more. As an added bonus, eTMF Connect’s easy-to-use interface has made the transition easier for newer team members who are still getting acquainted with using an eTMF system. “We’re happy to have a system that does what it promises to do,” said Kimberly Swint.

Results

• Montrium’s detailed onboarding plan and dedicated Customer Experience team ensured that eTMF Connect was implemented by the agreed upon date and without delays.

• Comprehensive training helped new and experienced employees alike grasp the details of the system quickly and successfully.

• Study start-up has been expedited as a result of the ability to add pre-defined sites and contacts via the Global Contacts and Navigator features.

• The user-friendly interface has been beneficial for training new employees in the eTMF.

• Review procedures have been simplified thanks to the ability to filter by site and process zone.

• With a system that auto-populates process zones based on document name, getting documents where they belong has never been quicker.

•The staging area has allowed those working in the eTMF to get a handle on indexing and other document functions without sacrificing inbound QC.

Key achievements

80%

increase in efficiency in trial documentation

80%

improvement in trial oversight

60-80%

improvement in timeliness

Favourite features

The staging area

The staging area has allowed those working in the eTMF to get a handle on indexing and other document functions without sacrificing inbound QC

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