NEW YORK & NESS ZIONA, Israel--(BUSINESS WIRE)--Medidata (NASDAQ:MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, announced today that its cloud technology platform has been adopted by Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI/PLTR). The Israeli biotech will deploy Medidata Rave® to capture, manage and maximize the value of its clinical data.
Bioforum Ltd., a data-focused contract research organization (CRO) and a certified Medidata partner based in Israel, has been selected by Pluristem to implement and configure Medidata Rave, the industry’s leading unified electronic data capture (EDC) solution.
“Pluristem’s goal is to provide patients, doctors and healthcare systems around the globe with standardized, easy-to-use and highly effective cell therapies,” said Dr. Esther Lukasiewicz Hagai, vice president medical & clinical affairs of Pluristem. “To ensure efficiency in our studies and the accuracy of our clinical trial data, it’s essential that we use the most cutting-edge technology. The Medidata-Bioforum partnership provides our teams with real-time visibility into clinical data, enabling us to have better oversight of our trials and make more informed decisions.”
Pluristem develops placenta-derived, “off-the-shelf” products that do not need tissue matching prior to administration. The cells are grown using a unique, proprietary, three-dimensional (3D) technology platform to develop cell therapies for conditions such as inflammation, ischemia, hematological disorders, or exposure to radiation.
“Pluristem’s placenta-derived cell therapies are an exciting development in the field of clinical research that is pushing the boundaries of science forward,” said Christian Hebenstreit, Medidata’s managing director of Europe, the Middle East and Africa (EMEA). “We’re pleased that our technology and partnership with Bioforum are helping to drive innovation and look forward to working with Pluristem as it develops therapies with the potential to improve the health of patients.”
Medidata and Bioforum will initially support the PLX-R18 Phase I trial, which Pluristem is conducting to treat incomplete hematopoietic recovery following Hematopoietic Cell transplantation (HCT).
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Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
Bioforum provides a wide range of services in the areas of Education and Training, Clinical Data, Regulatory Submissions and Clinical Supply (IMP). Bioforum's strategic lines of business combine professional services, process optimization, technology and education.
Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. We are committed to advancing the competitive and scientific goals of our life sciences customers worldwide: more than 700 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations. Our industry-leading technology platform, the Medidata Clinical Cloud®, is the primary technology solution powering clinical trials for 17 of the world's top 25 global pharmaceutical companies, bringing new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting.