Placenta-based cell therapy products developer Pluristem Therapeutics has adopted Medidata's cloud technology platform.
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).