Pro-Pharmaceuticals and Medidata Solutions Team Up to Implement
EDC in Phase II Clinical Trial
- Clinical Data for New Generation of Anti-Cancer Treatments Captured Using
Medidata's RAVE Solution -
NEW YORK, March 14 /PRNewswire/ -- Medidata Solutions Inc., a global
electronic clinical data management solutions provider managing trials in 40
countries, today announced that it will provide Pro-Pharmaceuticals, Inc. (AMEX:PRW), a developer of novel carbohydrate compounds that enable the
targeted delivery of chemotherapy drugs to cancer cells, with state-of-the-art
electronic data capture (EDC) technology for Pro-Pharmaceuticals' Phase II
clinical trial. Medidata RAVE is enabling accurate collection of data through
its web-based interface yielding faster data availability for trend analysis.
"Our goal is to gain valuable real time insight into collected trial data and
give our medical team effective tools for decision making which could enhance
and accelerate the clinical trials and our drug development program," said
Eliezer Zomer, Ph.D., Vice President Product Development & Manufacturing,
Pro-Pharmaceuticals. "We teamed with Medidata for our Phase I clinical trial
because of their comprehensive, state-of-the-art and easy-to-use electronic
data capture capabilities as well as their rapid implementation times and
professional standard of service. We look forward to working with Medidata on
our Phase II clinical study." Credible and precise outcomes data is a key factor to the regulatory agencies
that scrutinize clinical trial results. With Medidata's validated collection
processes and 21 CFR Part 11 Compliant RAVE solution, Pro- Pharmaceuticals will
obtain the electronic data capture benefits of rapid and accurate trial data,
as well as the accompanying cost savings and a decreased cycle time for follow
on studies.
Pro-Pharmaceuticals has initiated a Phase II clinical trial to evaluate
efficacy and safety of DAVANAT/5-FU when administered in monthly cycles as a
third-line therapy for metastatic colorectal cancer.
"Medidata RAVE is a key component in the fast, accurate analysis of the
efficacy of DAVANAT for critically ill cancer patients", said Tarek Sherif,
CEO, Medidata Solutions. "Since our company mission is to develop technology
that assists advanced research organizations like Pro-Pharmaceuticals bring new
treatments to market, we are delighted to team up with Pro-Pharmaceuticals on
this research. Medidata RAVE will reduce the latency of information flow,
providing Pro-Pharmaceuticals with immediate insight into the ongoing status of
their clinical trial." About Medidata Solutions Medidata Solutions understands and helps customers manage the business of
electronic Clinical Data Management better than any one else. Designed to
reduce the latency of information flow, optimize decision-making and improve
resource allocation and safety, Medidata Solutions' flexible, enterprise class
workflow and web-based technology assists global life sciences and research
organizations to accelerate the process of bringing life-enhancing treatments
to market. Streamlined collection, verification, consolidation and analysis of
clinical research data gives front line investigators, data managers and
executives, powerful tools to make more precise decisions earlier, reduce costs
and drive efficiency. To learn more about Medidata Solutions visit
http://www.mdsol.com/.
Pro-Pharmaceuticals, Inc. - Advancing Drugs Through Glycoscience(R) Pro-Pharmaceuticals is a drug development company commercializing a new
generation of anti-cancer treatments using carbohydrate compounds to Glyco-
Upgrade(TM) the safety and efficacy of FDA-approved chemotherapy drugs. The
Company has been conducting pre-clinical studies for irinotecan, doxorubicin,
oxaliplatin, paclitaxel, cyclophosphamide, and most recently with AVASTIN(TM)
both in combination with DAVANAT and other polysaccharide compounds. Human
colon and breast xenography are being used to optimize formulations and results
show that DAVANAT exhibits a broad spectrum of activity with tested drugs.
Additional information is available at http://www.pro-pharmaceuticals.com/. DATASOURCE: Medidata Solutions Inc.
CONTACT: Ed Viviani of Medidata Solutions, +1-212-918-1800, ; Anthony D. Squeglia of Pro-Pharmaceuticals, Inc., +1-617-559-0033, Web site: http://www.mdsol.com/ http://www.pro-pharmaceuticals.com/
|