Industry Survey Reveals 99% of Clinical Operations Leaders Report the Need to Unify Their Clinical Applications
There is an industrywide drive toward a unified clinical operating model, according to the Veeva 2017 Unified Clinical Operations Survey, one of the industry’s largest annual surveys of clinical operations professionals. The new research from Veeva Systems (NYSE: VEEV) reveals that nearly all respondents cite the need to unify their clinical applications, including EDC, CTMS, and eTMF. More than 60% say faster study execution and improved study quality are the top drivers toward a unified clinical model, which is characterized by end-to-end processes and systems, visibility across the clinical lifecycle, and modern information systems.
Streamlining Clinical Systems and Processes
Many of the challenges sponsors face today in managing clinical trials stem from the disparate nature of their processes and systems. Respondents use an average of four applications to manage their clinical studies and more than one-third use at least five applications. The most commonly used applications are EDC and CTMS (81% and 59% respectively).
Nearly all survey respondents have at least one major challenge with their clinical applications and the top two challenges – integrating multiple applications (69%) and reporting across applications (61%) – are a direct result of system silos. Half of sponsors say issues integrating their EDC or eTMF applications with CTMS limits their organization’s ability to improve clinical operations.
Companies also say their current clinical systems are hard to use (46%) and lack the ability to support collaboration (33%). Usability and accessibility issues likely contribute to the difficulties one-third say they face with data being tracked outside of their clinical systems.
Half of respondents also cite better study visibility as one of the most important drivers for unifying the clinical landscape, especially given the challenges most have with reporting across multiple applications. The ability for companies to collect and leverage operational data throughout the clinical lifecycle has a direct impact on improving efficiency and execution in clinical operations.
Transitioning to Modern Information Systems
Companies have started on a path to unified clinical enabled, in part, by the introduction of newer, more advanced applications and platforms. Trial master file (TMF) management is one of the first areas to experience rapid transformation. Over the past four years there has been a major shift as one in three (31%) sponsors now use an advanced eTMF application, more than double the number in 2014.
The transition toward modern, purpose-built eTMF applications and ‘active’ TMF management – the ability to manage information and processes in real-time as the TMF is being generated – is delivering greater benefits than ‘passive’ first-generation local file systems and cloud file shares. More than three-quarters (79%) of sponsors report improvements in inspection readiness after implementing an active eTMF application. Modern eTMF applications also significantly improve activities key to unifying clinical operations and better managing the growing volume and complexity of clinical trials, including visibility into key study performance metrics.
There is also a significant shift underway in clinical trial management as life sciences companies expect to increase their CTMS investments by almost 15% each year through 2020. This is being driven by rising demand for data and site collection solutions and the availability of next-generation CTMS applications.1 This is not surprising, given that nearly all sponsors (98%) say challenges with their current CTMS applications are limiting their ability to improve clinical operations. Among their biggest issues are their inability to fully support resource management (77%), study and site feasibility (76%), financial management (75%), and issue/task management (73%).
“The industry’s transition toward a unified clinical environment is being driven by its need to address the silos legacy systems have created,” said Jennifer Goldsmith, senior vice president of Veeva Vault. “Life sciences companies are taking steps to streamline their end-to-end processes and systems with modern applications so they can execute faster and improve visibility across their study portfolios.”
The Veeva 2017 Unified Clinical Operations Survey examines the life sciences industry’s progress toward a unified clinical environment by gathering the experiences and opinions of 300 clinical operations professionals from around the globe. Evolved from the annual Veeva Paperless TMF Survey, this research examines the drivers, barriers, and benefits of a unified clinical operating model and tracks the move to streamline clinical systems and processes.
In related news today, Veeva announced that Veeva Vault CTMS is gaining momentum as customers drive toward a unified clinical operating model. Within just two months of the product’s release, five customers, including a top 50 global pharmaceutical company, are implementing Veeva Vault CTMS. In more news, Regeneron Pharmaceuticals (NASDAQ:REGN), is standardizing on Veeva Vault Submissions and Veeva Vault eTMF to further streamline clinical and regulatory operations.
For more on Veeva 2017 Unified Clinical Operations Survey, visit: veeva.com/eu/ClinicalSurvey
For more on Veeva Vault Clinical Suite, visit: veeva.com/eu/Clinical
Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems
Follow @Veeva_EU on Twitter: twitter.com/veeva_eu
Like Veeva on Facebook: facebook.com/veevasystems
About Veeva Systems
Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 525 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit www.veeva.com/eu.
This release contains forward-looking statements, including the market demand for and acceptance of Veeva’s products and services, the results from use of Veeva’s products and services, and general business conditions, particularly in the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva’s expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva’s financial results are included under the captions, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the company’s filing on Form 10-Q for the period ended April 30, 2017. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.
1 Markets and Markets. eClinical Solutions Market, Global Forecast to 2020. 2016
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Pharnext: First-Half 201719.10.2017 17:30 | Pressemelding
Regulatory News: Pharnext SA (FR00111911287 - ALPHA), a biopharmaceutical company pioneering a new approach to the development of innovative drugs based on the combination and repositioning of known drugs, today announced its first-half 2017 financial results. Daniel Cohen, M.D., Ph.D. Co-Founder and CEO said of activity for the first half of 2017: "Activity in the first-half of the year was very dense; we implemented two prominent strategic partnerships with the biotech company Galapagos and the Tasly Group, one of the top ten pharmaceutical companies in China. Our flagship product, PXT3003 for the treatment of Charcot-Marie-Tooth disease type 1A, is nearing the end of Phase 3, which is slated for the second half of 2018. We confirm our target of taking the product to market by 2019." A half-year marked by strategic agreements
Tickets Now on Sale for FEI World Equestrian Games Tryon 2018, North Carolina, USA, on September 11-23, 201819.10.2017 16:58 | Pressemelding
Tickets for the FEI World Equestrian GamesTM Tryon 2018 (WEG) are now on sale to the public online at www.tryon2018.com. With more than 500,000 people expected to attend the 2018 Games, the 12-day spectacle of equestrian champions is one of the biggest events on the global sporting calendar and will be the largest equestrian event in North Carolina’s history. Mark Bellissimo, CEO of host venue Tryon International Equestrian Center (TIEC) in Tryon, NC, USA, said: “Demand from the event is way beyond our expectations and it would not surprise me if this event were to sell out early. We have experienced unprecedented demand, far bigger than we ever anticipated. There is tremendous appetite for this event, so we encourage people to buy now.” Tickets for the WEG include the following options: a standard Day Pass, Individual Event Pass, All Session Discipline Pas
SFL – Third-Quarter 2017 Financial Information19.10.2017 16:30 | Pressemelding
Regulatory News: SFL (Paris:FLY): Rental income: €147.8 million, up 3.3% like-for-like Consolidated revenue by business segment (€000’s) 2017 (9 months) 2016 (9 months)
AMRA and BioTelemetry Research Raise the Standard for Medical Imaging in NASH/NAFLD Clinical Trials19.10.2017 16:04 | Pressemelding
AMRA, the international leader in body composition analysis, and BioTelemetry Research (“BTR”), a leading global imaging and cardiac core lab, announced today the formation of an exclusive alliance for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) clinical trials. This first-to-market partnership will advance imaging science and benefit clinical trial sponsors in several musculoskeletal and metabolic therapeutic areas. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171019006110/en/ In clinical studies, muscle and fat fractions have traditionally been measured by scanning individual organs such as the liver, or particular body regions such as the abdomen. Commonly, researchers would prefer to scan the entire body in order to learn exactly where study participants are losing or gaining mu
AGCO Announces a New Data Connection with The Climate Corporation’s Climate FieldViewTM Digital Agriculture Platform19.10.2017 14:30 | Pressemelding
AGCO Corporation (NYSE:AGCO), a world-leading manufacturer and distributor of agricultural equipment, announced today a new digital partnership with The Climate Corporation, a subsidiary of Monsanto Company (NYSE:MON), that will provide AGCO customers the option to connect with The Climate Corporation’s Climate FieldView™ platform. AGCO’s partnership with The Climate Corporation is a product of Fuse and its open approach to agriculture, which focuses on helping customers optimize their farms through seamless technology integration and connectivity. “AGCO is excited to work with The Climate Corporation to give our customers yet another choice for Precision Ag solutions,” says Chris Rhodes, director Fuse Business Development. “The Climate FieldView platform is the world’s most broadly connected and adopted farm insight and visualization platform, and AGCO is pleased to be creating a tigh
Arrive Safely: Head to Tirendo and Equip Yourself Properly for Your First Winter19.10.2017 14:25 | Pressemelding
The days are getting shorter, and the thermometer is dropping. Especially for new drivers looking forward to their first winter behind the wheel, the sudden onset of snowy and icy roads can be a real challenge. Even more important, therefore, to make sure that you have the appropriate tyres for wintry driving conditions. Tirendo shares some tips on what this involves. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171019005888/en/ Head to Tirendo and equip yourself properly for your first winter - Photo source: ENZO In winter weather above all, the correct tread depth is crucial for safe driving. The legal minimum throughout Europe is 1.6 mm, however experts recommend at least 4 mm in snowy and icy conditions to ensure sufficient grip. To measure your tyre’s tread depth, simply take a two euro coin:
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom