Since 2000, the volume of data in a Phase III study has increased by more than 50 percent, and the cost per patient for a clinical trial has nearly doubled. Traditional electronic data capture (EDC) systems add to this complexity and cost by requiring site staff to spend a large amount of time managing clinical data. System set-up, maintenance, inflexibility and a lack of integration have slowed down the pharmaceutical industry’s ability to get clean data and quickly make informed, confident decisions during trials.
Veeva Systems Inc. has assumed a leading position in cloud-based software for the global pharmaceutical and life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 850 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia and Latin America. Founded in 2007 by Peter Gassner and Matt Wallach, Veeva works with software as a service (SaaS) in the global life-science industry.
Veeva’s industry cloud solutions provide data, software, services and an extensive ecosystem of partners to support critical functions from R&D through commercial. Veeva helps companies of all sizes bring products to market faster and more efficiently, while maintaining compliance.
Companies around the world are using Veeva to help change the way they do business. According to the company, 81 percent of new drugs approved were launched with Veeva CRM; there is 90 percent faster data change request resolution with Veeva OpenData; there is a 40 percent reduction in TMFreconciliation time with Vault eTMF; and there is a 50 percent reduction in submission development time with Vault RIM.
Veeva went public in 2013. In 2015, the company acquired Zinc Ahead, a content management software company. In 2019, Veeva acquired Crossix, a privacy-safe patient data and analytics company. As of August 21, 2020, it had a market capitalization of US$40 billion. On January 14, 2021 Veeva announced it will become a public benefit corporation on Feb. 1, 2021. This will make it the first publicly traded company and largest-ever to convert to a PBC. Veeva has more than 3,500 employees.
In 2020 Veeva announced MyVeeva for Patients, a new application for clinical research sites. With capabilities for virtual visits, patient adherence, ePRO, eConsent, eSource and an easy to use patient portal, MyVeeva for Patients is designed to make it easier for clinical research sites to deliver a patient-centric and paperless clinical trial experience for patients and sponsors. MyVeeva for Patients is free for clinical research sites and integrates seamlessly with Veeva SiteVault. Doctors can conduct virtual visits and make it easier for patients to participate in clinical trials.
“There is a pressing need for clinical solutions that reduce the burden on patients participating in trials and make study execution easier for sites,” said Jessica Collins, program director for investigator-initiated clinical trials at Vanderbilt University Medical Center. “Having the ability to conduct parts of a study remotely is key to a better patient experience and speeding study conduct. It’s a crucial shift for the industry, and I appreciate the innovation Veeva is bringing to this important area.”
MyVeeva for Patients enables patients, doctors, and clinical research coordinators to collaborate remotely with advanced audio and video capabilities, reducing the need for in-person visits. Clinical researchers can collect and record patient data electronically; make it more convenient for patients to report on treatment outcomes; easily share information electronically and get patient consent; and help patients take medications and adhere to their treatment regimens.
“COVID-19 created even greater urgency for clinical trials to become more virtual and deliver a safe, convenient patient experience,” said Henry Levy, general manager of Vault CDMS, site, and patient solutions at Veeva. “Enabling home-based trial visits with MyVeeva for Patients can advance the move to more patient-centric and paperless trials. We are excited to partner with the industry to help improve the clinical trial process for sponsors, sites, and patients.”
MyVeeva for Patients is part of the Veeva Clinical Network. This is a set of solutions that brings together sponsors, sites and patients to accelerate clinical research.
In addition to MyVeeva, Veeva in 2020 also launched Veeva Site Connect, a new application that connects sponsors and clinical research sites during trials. Together with Veeva Vault Clinical Suite, Veeva is the first and only company providing solutions that help sponsors, sites and patients to share and view information during a clinical trial. It is part of Veeva’s attempt to enable patient-centric clinical trials, which are especially important during a pandemic or other crisis situation.
According to Bree Burks, vice president of strategy, site solutions, at Veeva Systems, the company recently launched eConsent. The first patient has been consented using Veeva’s eConsent technology. It is owned by sites and used on any study they want. It is free, fully validated by Veeva and HIPAA and Part 11 Compliant. The focus is on improving the patient experience and digitizing the consent process
The eConsent platform is connected to Veeva’s eReg, which automates the most current version of the consent. All signed versions of consents are auto-filed back in a study/patient specific eBinder in eReg, sites only need to log into SiteVault and the eConsent is fully integrated into Veeva’s single site platform.
Additionally, eConsent is connected to Veeva’s patient app-MyVeeva. Patients sign and retain copies of their consents across studies in one application. Over time, patients can use MyVeeva to do all study related interactions such as medication adherence, answering PRO’s, communicating with their study teams and launching virtual visits.
It is also connected to sponsors. In the next release, the eConsent template will be shared from sponsors using Veeva technology to sites using Veeva eConsent to try and make the electronic consent process easier to build). Sites will have the ability to keep templates and content blocks to easily build new consents using standard template language/previous versions of consents to increase efficiency.