Berry Consultants Releases FACTS 7 Clinical Trial Simulator
Berry Consultants, LLC announced today that FACTS 7 was released to existing users and is now available to all new clients. FACTS (Fixed and Adaptive Clinical Trial Simulator) is the most powerful, flexible, and fastest simulation tool on the market for advanced clinical trial design. FACTS covers the whole spectrum of trial designs, from early development phase I trials, to innovative phase II trials, and efficient phase III designs. With the release of FACTS 7 and the new platform trial module, FACTS becomes the first commercially available and validated software for the design and simulation of adaptive platform trials.
The Berry Consultants team is the internationally renowned leader in the creation, design, and implementation of platform trials in many disease areas such as ALS, Breast Cancer, Alzheimer’s, Pancreatic Cancer, Glioblastoma Multiforme, Influenza, Pneumonia, and COVID-19, and is currently expanding platform trials into many more disease areas for sponsors. These platform trials are built with a master protocol to allow multiple therapies to be investigated in a single trial, being added continuously, all with shared infrastructure. In addition, a platform trial allows multiple arms to share a common control, share the common infrastructure of the trial, and it allows the better treatment of patients in the trial. The platform trial concept is a win-win for all stakeholders – smaller sample size, reduced patients on placebo, reduced costs, reduced timelines, and better inferences for regulators. Now with FACTS 7, this innovative approach of platform trials can be shared to commercial clients through licensing the FACTS software package.
Scott Berry, PhD, President and Senior Statistical Scientist at Berry Consultants, said, “This is an exciting day for our FACTS software and all of its users. This new design module and software release transforms FACTS to allow users to design an efficient adaptive platform trial. There are so many advantages of platform trials and now FACTS allows for thorough and efficient simulation for optimizing these trials.”
This initial platform trial module of FACTS 7 allows users to simulate trials where many treatments are tested, with treatments entering and leaving the trial over time. Its current simulation capabilities are for continuous and dichotomous endpoints with various trial level participant and arm constraints. In particular, users can specify a maximum enrollment time, number of participants, definition of successful treatments, participants per arm and concurrent treatments. In addition, it has the capability to simulate treatments arriving at different times during the trial and provide allocation options that include fixed proportion to control, allocation ratios dependent on the number of treatments and response adaptive randomization.
Tom Parke, Director of Software Solutions of Berry Consultants, added, "We are thrilled to be able to take some of the concepts and approaches of platform trials from the Berry Consultants scientific team and be able to apply that to our FACTS software. This new module brings some initial capabilities and features to our FACTS users as a first step, and we will be continuing to develop this platform trial software in future releases. We will continue to develop FACTS and provide to our users the latest and most innovative features in clinical trial design.”
With this release, FACTS continues to share a common structure, platform and philosophy: that simulation of clinical trials should be easy to set up, flexible, fast to run, and clear in their outcomes. FACTS allows users to specify trials across the whole spectrum from the simplest and widely used to the most innovative.
About Berry Consultants
Berry Consultants is a statistical consulting company specializing in innovative clinical trial design, analysis, execution, and software solutions for the pharmaceutical and medical device industry. We employ world-renowned experts in Bayesian statistics and strive to set the standard for adaptive clinical trial design and analysis across all medical disciplines. www.berryconsultants.com
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230412005122/en/
Contact information
Berry Consultants
(512) 213-6428
info@berryconsultants.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Protectoria Venture Signs Agreement to Propose a Decentralised Digital ID to Indonesia.7.6.2023 09:00:00 EEST | Press release
Protectoria Venture AS, https://protectoria.com/ , has together with its local partner, PT Gimle Investment Group, signed an agreement with PT INTI (Persero), the state-owned enterprise acting as a strategic trusted adviser to the central government, on proposing a decentralised digital identity infrastructure services for public entities, companies, and citizens in Indonesia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230606005888/en/ Foto: Protectoria The companies commit to cooperate exclusively to design, build and operate a digital decentralised identity infrastructure that can be offered towards any service provider from any sector or industry in a national roll-out. Citizens will be able to control their own data and have easy and secure access to all types of digital services in society. Protectoria Venture will provide the decentralised digital identity services based on the firm´s technology platform with archi
Hillstone Networks named a Customers’ Choice in the 2023 Gartner Peer Insights™ Voice of the Customer for Network Firewalls7.6.2023 09:00:00 EEST | Press release
Hillstone Networks, a leading provider of cybersecurity solutions, announced today that it has been included in two Gartner Peer Insights “Voice of the Customer” reports Hillstone has been recognized as a Customers' Choice vendor for Network Firewalls and named a Strong Performer for its newly released Network Detection and Resolution (NDR) solution. Gartner Peer Insights Customers' Choice distinctions are based on voluntary and verified feedback and ratings from end-user professionals who have experience purchasing, implementing, or using the products or services. “Customers have spoken and recognized our unwavering commitment to providing integrative cybersecurity solutions that have effectively delivered coverage, control, and consolidation to over 26,000 of their peers globally, in a challenging and dynamic cybersecurity landscape,” said Tim Liu, co-founder & CTO, of Hillstone Networks. “We will continue to innovate and push the boundaries of cybersecurity to protect our customers'
ReNew Announces Results for the Fourth Quarter (Q4 FY23) and Fiscal 2023, both ended March 31, 20237.6.2023 00:00:00 EEST | Press release
ReNew Energy Global Plc (“ReNew” or “the Company”) (Nasdaq: RNW, RNWWW), a leading decarbonization solutions company, today announced its consolidated IFRS results for Q4 FY23 and the fiscal year ended March 31, 2023. Operating Highlights: As of March 31, 2023, the Company’s portfolio consisted of 13.7 GWs, a 28.2% increase year on year, of which ~ 8.0 GWs are commissioned and 5.7 GWs are committed. 101 MW of Purchase Power Agreements (“PPAs”) were signed in the fourth fiscal quarter of 2023 and only ~1% of our total portfolio have Letters of Award that await a PPA. Total Income (or total revenue) for Q4 FY23 was INR 25,916 million (US$ 315 million), an increase of 47.1% over Q4 FY22. Adjusted EBITDA(2) for Q4 FY23 was INR 12,010 million (US$ 146 million), as against INR 12,787 million (US$ 156 million) in Q4 FY22. Net profit for Q4 FY23 was INR 74 million (US$ 1 million) compared to a net loss of INR 3,554 million (US$ 43 million) for Q4 FY22. Cash Flow to equity(2)(“CFe”) for Q4 was
Kenvue to Announce Second Quarter 2023 Results on July 20, 20236.6.2023 23:30:00 EEST | Press release
Kenvue Inc. (NYSE: KVUE) (“Kenvue”), the world’s largest pure-play consumer health company by revenue, today announced that its financial results for the second quarter ending July 2, 2023, will be released before market open on July 20, 2023. The company will host a conference call and webcast at 7:30 a.m. Eastern Time to report its second quarter results. The conference call can be accessed by dialing 877-407-8835 from the U.S. or 201-689-8779 from international locations. A live webcast of the conference call will be available at https://investors.kenvue.com. A replay will be available approximately two hours after the live event. About Kenvue Kenvue is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage and propelled forward by science, our iconic brands—including AVEENO®, BAND-AID® Brand Adhesive Bandages, JOHNSON’S®, LISTERINE®, NEUTROGENA®, TYLENOL® and ZYRTEC® — are recommended by health care professionals and can be truste
Bentley Systems Announces Allen Li has Joined as General Manager, China6.6.2023 23:01:00 EEST | Press release
Bentley Systems, Incorporated (Nasdaq: BSY), the infrastructure engineering software company, today announced that Allen Li has been appointed to the new role of General Manager, China, reporting to Chief Revenue Officer Brock Ballard. Allen Li has had a long executive career at enterprise software leader SAP, including as Chief Operating Officer, China. He earned a bachelor’s degree in Engineering and a master’s in Technology Management at Harbin Institute of Technology, and then an Executive MBA from University of Mannheim Business School. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230606006011/en/ Allen Li has been appointed to the new role of General Manager, China. Image courtesy of Bentley Systems. While Bentley’s infrastructure engineering offerings have become well established in major design institutes and owner organizations, the company is also pursuing substantial growth opportunities as a platform for softwa
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom