NEW YORK--(BUSINESS WIRE)--Medidata (NASDAQ:MDSO) and clinical-stage pharmaceutical company Karyopharm Therapeutics (NASDAQ:KPTI) today announced an expanded partnership to bring novel machine-learning technology and targeted risk-based monitoring (RBM) techniques to clinical oncology trials.
In addition to renewing its use of the Medidata Clinical Cloud® platform—including key capabilities within Medidata’s study conduct and site support suites—Karyopharm is adopting Medidata CSA (Centralized Statistical Analytics) and Medidata TSDV (Targeted Source Document Verification) to enhance its data review process and incorporate modern risk assessment practices into its drug development programs.
"As we advance our most promising cancer therapies, it is vital that Karyopharm embraces the latest technologies and evolving trends in the clinical trials space. Adopting Medidata's machine-learning capabilities for centralized monitoring will not only put us in line with the updated ICH E6 R2 guidelines, but will also allow us to view clinical information at a more holistic level, better prioritize trial resources, and maintain data quality and integrity,” said Ran Frenkel, chief development operations officer at Karyopharm. “Medidata is more than our technology provider of choice—they are a valued partner that is helping us reach our scientific goals sooner."
A Medidata customer since 2014, Karyopharm has been using Medidata’s industry-leading electronic data capture (EDC) and management system, Medidata Rave®, as well as integrated capabilities that plug into Rave—including randomization and trial supply management, medical coding, adverse event reporting and clinical trial management—to advance its pipeline of oncology-focused therapies. Together, these unified applications have streamlined Karyopharm’s clinical trial processes: reducing electronic case report form (eCRF) design times by 74%, improving data entry time by 64%, and reducing the cycle time to open, answer and close queries by 41%.
Now, Karyopharm will realize more value from the Medidata platform by leveraging Medidata CSA and Medidata TSDV, two integral capabilities within Medidata’s Strategic Monitoring solution. CSA’s machine-learning capabilities help to identify unusual clinical trial data anomalies within a study, enabling better prioritization of resources around data quality and integrity, as well as patient safety. Medidata CSA simplifies the site monitoring process, making it easier for teams to detect and track critical data errors throughout a clinical trial, while Medidata TSDV optimizes the data verification process by enabling sponsors to configure study-specific and site-specific SDV plans.
“Karyopharm is on the front line of cancer research, pursuing novel, first-in-class drugs to accelerate hope for patients, and we’re proud to be a strategic partner in that effort,” said Mike Capone, Medidata’s chief operating officer. “Our collective teams understand the power of utilizing pioneering technologies and innovative R&D approaches to push the envelope in scientific discovery. By combining our agile, machine-learning tools with Karyopharm’s therapeutic excellence, we look forward to driving meaningful and efficient clinical research for those who need it most.”
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About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport and related targets for the treatment of cancer and other major diseases. Karyopharm's SINE™ compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). The Company's initial focus is on seeking regulatory approval and commercialization of its lead drug candidate, oral selinexor (KPT-330). To date, over 1,900 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Karyopharm plans to initiate a pivotal randomized Phase 3 study of selinexor in combination with bortezomib (Velcade®) and low-dose dexamethasone (BOSTON) in patients with multiple myeloma in early 2017. In addition to single-agent and combination activity against a variety of human cancers, SINE™ compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm, which was founded by Dr. Sharon Shacham, currently has five investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.
Medidata is reinventing global drug and medical device development by creating the industry's leading cloud-based solutions for clinical research. Through our advanced applications and intelligent data analytics, Medidata helps advance the scientific goals of life sciences customers worldwide, including nearly 850 global pharmaceutical companies, biotech, diagnostic and device firms, leading academic medical centers, and contract research organizations.
The Medidata Clinical Cloud® brings a new level of quality and efficiency to clinical trials that empower our customers to make more informed decisions earlier and faster. Our unparalleled clinical trial data assets provide deep insights that pave the way for future growth. The Medidata Clinical Cloud is the primary technology solution powering clinical trials for 17 of the world's top 25 global pharmaceutical companies and is used by 16 of the top 20 medical device developers—from study design and planning through execution, management and reporting.