WESTBOROUGH, MA--(Marketwire - February 02, 2010) - PharmaVigilant, a clinical trial
technology provider, was recently selected by TissueGene to support a
three-year, Phase II study to test the efficacy and safety of a new drug
aimed at treating patients with a degenerative joint disease of the knee.
TissueGene, a privately-held biopharmaceutical company with a pipeline of
promising regenerative medicine therapeutics in the field of cell-mediated
therapy, chose PharmaVigilant as a result of its integrated imaging
capability in I-Vault.
Too large to be opened in traditional EDC systems, MRIs are a vital imaging
method to determine biomarkers for all phases of drug development.
Embedded into one single system, this industry-leading capability from
PharmaVigilant allows MRIs to be seamlessly integrated into the clinical
trial process, streamlining the storage, access and readability of the
images. By integrating this imaging capability into its I-Vault solution,
PharmaVigilant provides TissueGene researchers and trial end users, such as
radiologists, with a single login, significantly improving access and
control of the trial's MRIs. This is a marked difference from other
technology vendors who rely solely on their partnerships with other
organizations to provide MRI imaging capabilities to sponsors and require
additional steps and processes to manage and view images.
"I-Vault provides us with the opportunity to manage our trial participants'
MRIs through one integrated solution with a single login, rather than
relying on a separate organization to provide these capabilities," said Dr.
Kwan Hee Lee, President and CEO of TissueGene. "Access and control over
one's data is critical when conducting clinical trials, and we value the
opportunity to retrieve our data through a streamlined and secure process.
This has increased the efficiency of trial processes and improved the
quality of the data while yielding significant cost savings. Combined,
these factors will help us effectively determine the efficacy and safety of
this new drug."
"On its own, I-Vault is a game-changing solution, providing considerable
cost savings and decreasing the bottlenecks and delays that often hinder
the clinical trial process," said James DeSanti, CEO and Founder,
PharmaVigilant. "After integrating this advanced imaging capability into
I-Vault, we provide sponsors such as TissueGene the ability to consolidate
its imaging needs within one solution and bring ground-breaking drugs to
market quicker to help treat degenerative diseases."
PharmaVigilant offers a full suite of clinical trial technology offerings
including Electronic Data Capture (EDC), data warehousing, study building
(I-Builder), Electronic Trial Master File system (eTMF), Remote Source
Document Verification (rSDV), study administration and an automated site
payment system. PharmaVigilant focuses on Phase I-IV clinical trials,
registries and other post-marketing studies. The technology has supported
more than 200,000 patients in 14 countries across North America, Europe,
Asia and Australia and continues to expand rapidly.
Based in Westborough, Mass., PharmaVigilant is a technology company founded
in 2005 to demystify the clinical trial process for biopharmaceutical
companies. Its full suite of patient-based technology automates the
collection and management clinical trial data and most importantly puts
that data in the sponsors' hands when and how they want it. Sponsors rely
on PharmaVigilant to ease the regulatory and FDA submission and approval
process and ultimately go-to-market more quickly with top quality drugs.
For more information, visit www.pharmavigilant.com.