Company Accelerates Bladder Cancer Research by Unifying Content,
Data, and Workflows
NEW YORK & PETAH-TIKVA, Israel--(BUSINESS WIRE)--Nov. 20, 2017--
(NASDAQ: MDSO), the leading global provider of cloud-based solutions and
data analytics for clinical research, today announced that MEL
MEDICAL Enterprises, has selected Medidata eTMF to carefully and
effectively manage regulated content involved in the development of new
therapies for patients with non-muscle invasive bladder cancer.
MEL MEDICAL Enterprises is a global medical devices company specializing
in developing minimally invasive therapeutic technologies for bladder
cancer patients. By using Medidata eTMF, the company will achieve
greater efficiency and transparency from study planning to study close.
MEL will be able to better streamline communication and secure
management of its Trial Master File (TMF) across 20 global sites and 2
labs while maintaining complete compliance and an audit trail that is
“As clinical trial complexities and regulatory pressures continue to
increase in scope, efficiently maintaining and extracting both data and
content in a compliant manner are paramount to successful trial
outcomes,” says Igal Ruvinsky, vice-president clinical affairs, at MEL
MEDICAL Enterprises. “To power our next cycle of clinical research, we
need an easy to use, unified solution with a long-standing reputation as
a stable system that streamlines data in the cloud. We look forward to
collaborating with Medidata to bring life-saving therapies to cancer
patients with greater ease and compliance.”
As part of the Medidata Clinical Cloud®, Medidata
eTMF regulated content management solution accelerates study startup
by efficiently standardizing and automating trial master file
documentation. It allows users to create, store, view, edit and
collaborate on an entire TMF lifecycle in a single application with
cutting-edge UX capabilities fully integrated with Box.
Powered with the first-of-its-kind Live Content Verification technology,
it further supports higher compliance standard and inspection readiness
throughout the study lifecycle.
“The adoption of eTMF solutions is significantly accelerating in the
life sciences sector, and we’re proud to deliver the industry’s most
comprehensive end-to-end platform that allows our customers to make
better decisions during the clinical development process,” said Kevin
Barrett, vice president document management solutions at Medidata.
“We’re proud to partner with MEL MEDICAL Enterprises to improve the
collaboration between clinical teams and trial stakeholders as they
focus on new treatments for one of the most common malignancy among men
About MEL MEDICAL Enterprises
Medical Enterprises Group is a growing and dynamic medical device
company. It has its headquarters in Amsterdam, The Netherlands, where
sales and marketing activities are managed. Research and Development,
technical support and clinical activities are managed from the facility
in Israel. MEL MEDICAL’s R&D staff is a multifunctional team composed of
physicists, electrical and mechanical engineers, software and QA
experts. The clinical department is led by PhD level scientists who
provide medical support to Urology Departments around the world, and
handle clinical trials and publications. The company is focused on
developing minimally invasive therapeutic technologies which provide
benefits for both patient and healthcare system. The company's leading
product, Synergo®, offers an advanced treatment modality for patients
suffering from non-muscle invasive bladder cancer.
is reinventing global drug and medical device development by creating
the industry's leading cloud-based solutions for clinical research.
Through our advanced applications and intelligent data analytics,
Medidata helps advance the scientific goals of life sciences customers
worldwide, including over 950 global pharmaceutical companies, biotech,
diagnostic and device firms, leading academic medical centers, and
contract research organizations.
The Medidata Clinical Cloud® brings a new level of quality and
efficiency to clinical trials that empower our customers to make more
informed decisions earlier and faster. Our unparalleled clinical trial
data assets provide deep insights that pave the way for future growth.
The Medidata Clinical Cloud is the primary technology solution powering
clinical trials for 18 of the world's top 25 global pharmaceutical
companies and is used by 18 of the top 25 medical device developers—from
study design and planning through execution, management and reporting.
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