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PharmaMar, a Spanish biopharmaceutical company, has selected
Medidata Solutions (NASDAQ: MDSO) for its industry-leading electronic data capture (EDC) and clinical data management (CDM), safety data capture and reporting, and medical coding solutions. A member of the Zeltia Group and a leader in the development of antitumor drugs of marine origin, PharmaMar said the company’s investment in the
Medidata Clinical Cloud™ will efficiently streamline its clinical trial processes in its mission to deliver drugs that treat cancer and rare ("orphan") diseases.
A midsize pharmaceutical company investing heavily in research and development, PharmaMar has the world’s largest marine organism library, with over 135,000 specimens, and owns over 1,800 patents issued or in process. To replace paper-based clinical trial processes, PharmaMar sought an EDC system that would be easy to use and streamline the availability of reliable trial data for analysis. Following a successful deployment of
Medidata Rave® in 2012, PharmaMar decided to use Rave for all future trials. It also chose Medidata’s
Safety Gateway and
Medidata Coder® to swiftly capture and code safety data, and is evaluating other applications across the Medidata Clinical Cloud platform to help enhance trial efficiencies and decision making effectiveness.
“Our sites in Europe and the U.S. recommended Medidata for its ease of use. In implementing the Medidata Clinical Cloud we found that we had earlier access to reliable data to help us make decisions for optimal patient safety and patient experience,” said Dr. Arturo Soto, clinical development director at PharmaMar. “Medidata has proven to be a collaborative partner, working tirelessly with us to help us efficiently meet the challenges of our complex oncology clinical trials.”
PharmaMar required a system that was compliant with industry standards, particularly CDISC data models, for easy integrations and data sharing with its other systems. With its commitment to the Medidata’s standards-based platform, PharmaMar is now leveraging Medidata’s knowledge transfer program to quickly take technology management in-house.
“We commend PharmaMar for their innovative research in identifying new molecules through its marine-based research program for treatment of cancer and other diseases,” said Glen de Vries, president, Medidata Solutions. “As we welcome our first customer headquartered in Spain, we look forward to helping them bring those innovative therapies to market on our cloud platform.”
About PharmaMarPharmaMar is a biopharmaceutical subsidiary of Grupo Zeltia; it is a world leader in discovering, developing and selling marine-based drugs to treat cancer. Yondelis
® is Spain's first antitumour drug. Yondelis is currently approved for soft tissue sarcoma (STS) in 42 countries outside the EEA, and for platinum-sensitive relapsed ovarian cancer (ROC) in 31 of those countries plus Brazil. Yondelis is approved for STS and platinum-sensitive ROC in all 30 countries of the EEA. Yondelis is also undergoing Phase II trials on breast and paediatric cancers. PharmaMar has four other compounds in clinical development: Aplidin
®, PM01183 and PM060184. PharmaMar also has a rich pipeline of pre-clinical candidates and a major R&D programme.
About Medidata SolutionsMedidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers’ clinical trials. Medidata’s advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. Our diverse life science customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.