Veeva’s Industry Survey Shows 87% of Clinical Operations Leaders Taking Action to Unify Clinical Processes
Over the past year, there has been significant industrywide momentum toward streamlining clinical systems and processes, according to one of the largest annual life sciences surveys of clinical operations professionals from Veeva Systems (NYSE:VEEV).
The latest findings of the Veeva 2018 Unified Clinical Operations Survey reveal that nearly all (99%) clinical leaders surveyed cite the need to unify their clinical environment. Most (87%) report their organizations are taking action with initiatives planned or underway to unify their clinical operations for improved trial performance.
Consistent with the industry’s focus to advance operational performance, many have also made progress modernizing their clinical processes with the adoption of purpose-built applications in key areas. Most notably, the number of organizations that have adopted eTMF applications has quadrupled since 2014, and a majority of respondents (83%) say they have, or plan to have, programs to improve study start-up processes.
End-to-End Visibility, Faster Trial Execution Among Top Needs
Standalone eClinical applications, including EDC, CTMS, and eTMF, are now the norm as sponsors and CROs have steadily adopted function-specific clinical technologies. Application silos are contributing to the industrywide move to unify the clinical operations landscape. Sponsors and CROs say integrating multiple applications (74%) and managing content and data (56%) across them are among the top challenges with their clinical applications.
Findings indicate that disconnected applications hinder the ability to get a full view of clinical trial processes and slow execution. Better visibility and oversight is the primary driver for unifying clinical applications for 77% of respondents, followed by faster study execution (67%) and improved study quality (62%). With a unified clinical environment, organizations can streamline collaboration across study partners and ensure all parties are working within complete end-to-end trial processes.
Consistent use of standardized metrics and KPIs to measure trial performance is one of the greatest areas of opportunity for improving clinical operations. Data shows that those extensively using standardized operational metrics and KPIs report fewer challenges across key trial processes, including study performance metrics and reporting (44% versus 66%, respectively) and visibility into TMF status (32% versus 45%, respectively).
Modernization of Trial Processes Underway
The industry is advancing its processes and systems in major clinical areas such as eTMF and study start-up to impact visibility, collaboration, and compliance, yet significant opportunities remain to further improve efficiency in other operational areas, including CTMS.
Adoption of eTMF has grown significantly and is now the second most commonly used clinical system at 66%. At the same time, the types of eTMFs used has also changed dramatically. Half of sponsors (50%) now have a purpose-built eTMF application versus 13% in 2014. This increase was matched by a sharp decline in the use of general purpose content management systems and file shares. This signals a shift away from passive TMF management toward a mature, active TMF operating model where TMF processes and information are managed in real-time. These active TMF solutions have a positive impact on inspection-readiness and trial performance.
Organizations are also looking at upstream process improvements as an area of significant potential, focusing on study start-up processes and leveraging study start-up applications as major priorities. Top drivers for moving to purpose-built study start-up applications include faster study start-up times (63%), improved site feasibility and site selection outcomes (48%), and better visibility into site performance (44%).
Respondents also cite the need to improve their CTMS as 84% say it is a limiting factor in trial operations. Most have CTMS applications that cannot fully support a range of key functions, including governance and oversight (89%), resource management (88%), and issue and task management (86%). They see improving the CTMS as a way to gain greater visibility (70%), more proactive risk mitigation (65%), and improved study analytics and reporting (61%).
“The life sciences industry sees a significant opportunity to run far more efficient and effective trials,” said Jennifer Goldsmith, senior vice president of Veeva Vault. “As organizations continue down the path toward a unified operating model, trial processes will be transformed for greater visibility and improved trial execution across the clinical lifecycle.”
The Veeva 2018 Unified Clinical Operations Survey examines the life sciences industry’s progress toward a unified clinical environment by gathering the experiences and opinions of 331 clinical operations professionals from around the globe. This research examines the drivers, barriers, and benefits of a unified clinical operating model and tracks the industry’s progress in its move to streamline clinical systems and processes.
For more on Veeva 2018 Unified Clinical Operations Survey, visit: veeva.com/eu/ClinicalSurvey
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 625 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, 2018. 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.
Veeva 2018 Unified Clinical Operations Survey
The Veeva 2018 Unified Clinical Operations Survey examines the life sciences industry’s progress toward a unified clinical environment by gathering the experiences and opinions of 331 clinical operations professionals from around the globe. One of the largest annual life sciences surveys of its kind, this research examines the drivers, barriers, and benefits of a unified clinical operating model and tracks the industry’s progress in its move to streamline clinical systems and processes.
Industrywide Momentum to Unify Clinical Processes
- Nearly all respondents (99%) report the need to unify their clinical trial operating environments, and 87% have or plan to have an initiative underway to unify their clinical operations for improved trial performance.
- The top drivers for unification are to improve visibility and oversight (77%), enable faster study execution (67%), and improve study quality (62%).
- An average of four applications are used to manage their clinical studies, and more than one-third (38%) use at least five applications.
- Integrating multiple applications (74%) is the top challenge resulting from application and process silos, followed by reporting across multiple applications (57%), and managing content and data across applications (56%).
- Clinical applications are now the norm, with EDC (90%), eTMF (66%), RTSM (61%), and CTMS (60%) as the most commonly used applications.
- Those extensively using standardized operational metrics and KPIs to measure clinical trial performance, manage risks, and implement process improvements report fewer challenges across key trial processes, including study performance metrics and reporting (44% versus 66%, respectively) and visibility into TMF status (32% versus 45%, respectively).
- Organizations using metrics are four times more likely to have programs underway to unify their clinical applications than those not using metrics (47% versus 12%, respectively).
Increased Industry Adoption of eTMF Applications
- Half of sponsors now use a purpose-built eTMF application, nearly four times the number since first measured in 2014 (13%).
- The increase in use of purpose-built eTMF applications is matched by a 57% decrease in the use of general-purpose content management systems. This signals a shift away from a passive TMF operating model toward active solutions characterized by the ability to manage TMF processes and information in real-time as the TMF is being generated.
- Organizations’ primary drivers for using purpose-built eTMF applications are improved inspection readiness (70%), better visibility (61%), and improved collaboration across study partners (42%).
Opportunity to Improve Clinical Performance
- Nearly all respondents (99%) cite issues when asked about their most challenging clinical trial management processes, including study performance metrics and reporting (51%), study and site management (49%), and resource management (45%).
- All respondents say they want to improve use of CTMS in their trial operations, with the top drivers being greater visibility (70%), more proactive risk mitigation (65%), and improved study analytics and reporting (61%).
- A majority of respondents (84%) report significant deficiencies with their current CTMS applications, with almost all highlighting the inability to fully support key functions like governance and oversight (89%), resource management (88%), and issue and task management (86%).
Streamlining Study Start-up a Top Priority
- A key finding reveals that streamlining study start-up processes is gaining traction, with 83% of respondents reporting their organizations have a study start-up improvement initiative underway.
- More than half of respondents (53%) report site contract and budgeting among the most challenging study start-up processes that limit their organization’s ability to speed clinical trials, followed by IRB and ethics committee planning and approval (45%), and site identification and selection (41%).
- More than half of respondents (63%) cite faster study start-up times as the primary driver for improving study start-up processes, followed by streamlining site contract and budgeting approval cycles (49%) and improving site feasibility and site selection outcomes (48%).
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
JPMorgan Chase Bank announces the placement of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 22:40 | Tiedote
NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the placement of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest. The Bonds will be issued with an issue price of 100% and will redeem at par on 30 December 2020. The initial exchange price (the “Initial Exchange Price”) will
Boston Capital Announces Closing of Boston Capital Income & Value U.S. Apartment Fund17.7.2018 17:00 | Tiedote
Boston Capital, the third largest owner of apartments in the U.S. with over $19.6 billion invested, is pleased to announce the final investor closing of Boston Capital Income and Value U.S. Apartment Fund (“BCIV”). BCIV, a discretionary multi-investor Luxembourg based fund vehicle, includes financial institutions, insurance companies, pensions, and family offices among its investors and will acquire over $350 million in apartment properties throughout the U.S. “We are very pleased to close BCIV, the latest in a succession of institutional investment vehicles through Boston Capital’s conventional apartment investment arm, Boston Capital Real Estate Partners (“BCRE”),” said Jeff Goldstein, COO and Director of Real Estate at Boston Capital. The Fund generates high current dividends and capital growth by acquiring and renovating Class B apartment properties located in major and secondary U.S. markets and by targeting a renovated rental price point well below new construction rates, which a
Amobee Wins Auction Process to Acquire Videology Assets17.7.2018 16:13 | Tiedote
Singtel subsidiary Amobee, a leading global digital marketing technology company serving brands and agencies, today announced that it has emerged as the winner in the court supervised auction to acquire certain assets from Videology, a software provider for advanced TV and video advertising, for purchase price of approximately US$101 million1. The purchase price is subject to adjustments for accounts receivable at closing, estimated to be approximately US$20.9 million. The acquisition, following Videology’s voluntary Chapter 11 restructuring proceedings, includes Videology’s technology platform, intellectual property and certain other assets of estimated net book value of US$5.3 million2. Over the past decade, Videology has emerged as a leading provider of software that empowers advertisers and publishers to use data to optimize campaigns and spend across digital platforms and television. The addition of Videology’s capabilities will be a further boost to Amobee’s omni-channel platform
Lenovo Leaps Forward with Next-Generation ThinkAgile Composable Cloud Platform17.7.2018 15:00 | Tiedote
Lenovo Data Center Group (HKSE: 992) (ADR: LNVGY), one of the fastest growing hyperconverged infrastructure (HCI) vendors according to IDC, – with HCI revenue growing at almost twice the market growth rate in Q1 2018 (149.1% compared to 76.3%)—is further expanding its ThinkAgile portfolio to provide an innovative solution for customers who desire the agility of the public cloud and the security of a private cloud. To address this growing customer trend, Lenovo – together with Cloudistics – has developed the ThinkAgile CP Series composable cloud platform, a ‘cloud-in-a-box’ that offers all of the conveniences and ease-of-use of a public cloud environment secured behind the customer’s own data center firewall. Lenovo ThinkAgile CP Series – with fully-integrated infrastructure, application marketplace and end-to-end automation of software-defined network, compute and storage – delivers a turnkey cloud experience that can be easily and centrally managed from anywhere through a software-as-
JPMorgan Chase Bank launches offering of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 15:00 | Tiedote
NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the launch of an offering of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of up to approximately USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Issuer is rated A+ (Stable outlook) by Standard & Poor’s, Aa3 (Stable outlook) by Moody’s and AA (Stable outlook) by Fitch. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest.
Greene Tweed Achieves Nadcap Accreditation for Non-Metallic Materials Testing17.7.2018 14:01 | Tiedote
Greene Tweed’s Central Engineering (CE) Materials Test Lab recently completed its final Nadcap accreditation audit for Non-Metallic Materials Testing (NMMT) of composite materials. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180717005200/en/ Greene Tweed Achieves Nadcap Accreditation (Photo: Greene Tweed) In support of Aerospace’s strategic initiative, this positions Greene Tweed as one of a select few aerospace companies who have attained this accreditation as validation of our materials testing capabilities and our position as a composite solutions provider. To achieve this standard, Greene Tweed’s CE lab completed a comprehensive audit against the highest standards for special process controls, test completion, and validation. This in-house accreditation adds to Greene Tweed’s responsiveness to new product development requests while expanding production material and customer product certification capabilities. It also
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme