Cala Health Streamlines Data and Operational Management for Neurological Device Study with Medidata Cloud
Study leverages Medidata Rave EDC, Edge eTMF and Edge Payments
Cala Health unifies data and streamlines payments and document management on the Medidata Cloud
Medidata supports observational study of first-in-class non-invasive, targeted nerve stimulator for the treatment of Essential Tremor
The one platform approach eliminates need for multiple vendors to manage study operations
NEW YORK – Dec. 18, 2018 - Medidata (NASDAQ: MDSO) today announced that Cala Health, a neuromodulation platform company developing wearable therapies for chronic disease, is adopting the Medidata Cloud to centralize management of a large observational study.
Cala Health’s lead product, Cala TWO, delivers patterned electrical stimulation to nerves through the skin twice per day. The PROSPECT study will expand the understanding of therapeutic effect and patient experience with an on-demand therapy over three months.
The Medidata Cloud, the Intelligent Platform for Life Sciences, will:
Centralize and unify data for cross-team collaboration and to maintain inspection readiness
Streamline internal processes, including payments and the management of study documents
Eliminate the need for multiple vendors to manage the study
“We looked for reputation, scalability, and a complete platform approach for all stakeholders involved in our observational study, and found exactly that with Medidata eTMF, Rave EDC and Payments,” said Manish Gupta, VP, Clinical Affairs, Cala Health.
Cala Health will gain end-to-end efficiency by streamlining internal, labor-intensive study steps with Medidata:
Edge eTMF: an end-to-end TMF management platform to manage all data and content
Rave EDC: to unify, manage and report all patient data
Edge Payments: to automatically trigger, calculate and disburse payments directly into a site’s bank account
“We’re thrilled Cala Health is partnering with Medidata for this landmark neurological device study,” said Glen de Vries, president and co-founder, Medidata. “Our unified platform eliminates operational burdens at medical device companies so they can streamline processes and focus on research.”
Medidata is leading the digital transformation of life sciences, with the world's most used platform for clinical development, commercial, and real-world data. Powered by artificial intelligence and delivered by the #1 ranked industry experts, the Intelligent Platform for Life Sciences helps pharmaceutical, biotech, medical device companies, and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata serves more than 1,000 customers and partners worldwide and empowers more than 100,000 certified users every day to create hope for millions of patients. Discover the future of life sciences: www.mdsol.com
About Cala Health, Inc.
Cala Health is a neuromodulation platform company developing wearable therapies for chronic disease. The company is merging innovations in neuroscience and technology to deliver individualized, prescription wearable therapies. These therapies treat chronic disease non-invasively by stimulating peripheral nerves. The first indication for Cala’s wearable therapy will be Essential Tremor, a disease experienced by more than seven million people and characterized by severe hand tremors that impact daily quality of life. Cala is further developing its technology for several other indications in neurology, cardiology and psychiatry.
The company is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology. For more information, please visit www.calahealth.com.
Betsy Frank, +1 917-522-4620
Erik Snider, +1 646-362-2997