Gala Therapeutics, Inari Medical, and Lumicell modernize research operations
to manage growing complexity in trials and improve compliance
PLEASANTON, CA — April 20, 2021 — Increasing complexity in medtech clinical trials and changing regulations like EU MDR and IVDR require data collection and analysis on a much larger scale. To better manage data and speed time to market, more fast-growing device and diagnostics companies are adopting Veeva MedTech solutions. Gala Therapeutics, Inari Medical, and Lumicell use Veeva MedTech Vault Clinical Suite applications from Veeva Systems (NYSE: VEEV) to conduct and manage trials while maintaining inspection readiness.
Veeva MedTech solutions bring together content and processes to simplify trial execution and ensure compliance. For medtech, adopting advanced clinical applications is a foundational step to meet unique data requirements and regulations and enable faster product development.
Gala Therapeutics unifies clinical on a single cloud platform
Gala Therapeutics focuses on developing therapies for patients with pulmonary diseases. A fast-growing company with an extensive portfolio of innovative pre-market products, Gala needed more efficient and connected ways of managing clinical trials. The company is standardizing on Vault Clinical Suite to build studies fast, streamline clinical trial processes, and stay inspection ready.
“Veeva MedTech delivers a platform that will scale with us as we develop new products and expand into global markets,” said James Stambaugh, senior vice president of clinical affairs and strategy at Gala Therapeutics. “Being able to run trials end-to-end on a connected system delivers the visibility and control to speed our total product lifecycle.”
Inari Medical modernizes TMF management
A pioneer in designing venous thrombectomy devices, Inari Medical adopted Veeva Vault eTMF to align stakeholders while improving study document visibility and control with a modern electronic Trial Master File (eTMF) system. Now Inari Medical can manage documents in real-time and ensure inspection readiness. With more effective clinical trial oversight, the company is prepared to help more patients with their increasing evidence portfolio.
“Veeva Vault eTMF allows us to manage study documents efficiently and with a high level of quality,” said Keith Hebert, senior director, clinical research at Inari Medical. “We now have a system that provides precision and speed to support our evidence needs.”
Lumicell improves clinical trial efficiency
An innovative diagnostics leader in image-guided cancer surgery, Lumicell works with diverse research sites and large academic medical centers to run clinical trials. With several studies moving into pivotal stage, Lumicell wanted to reduce complexity and streamline collaboration with partners. The company selected Veeva Vault CDMS to accelerate study timelines and Vault eTMF to enable active TMF management.
“We needed the flexibility to build studies how we want and get them up and running fast,” said Hetvi Patel, senior clinical trial associate at Lumicell. “Veeva MedTech solutions help us streamline processes with greater control, improving compliance across clinical data and operations.”
“Small and mid-sized medtech companies are driving incredible innovations in healthcare,” said Kevin Liang, senior director, clinical strategy, Veeva MedTech. “We’re proud to partner with these high-growth companies to deliver flexible, agile solutions that increase efficiency across the clinical trial ecosystem.”
Veeva MedTech provides unified suites of cloud applications, including the Vault Clinical, Vault Quality, Vault Regulatory, Vault Medical, and Vault Commercial Content Management suites, for medtech companies to manage regulated content and data throughout the product lifecycle.
For more on Veeva MedTech, visit: veeva.com/medtech/
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About Veeva Systems
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 975 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com/.
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