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HeartFlow Appoints Timothy Barabe to its Board of Directors

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REDWOOD CITY, Calif., Jan. 18, 2022 (GLOBE NEWSWIRE) — HeartFlow Holding, Inc., the leader in revolutionizing precision heart care, today announced the appointment of Timothy Barabe to its Board of Directors.

“We are honored to have an accomplished leader like Tim join the HeartFlow Board,” said William C. Weldon, Chairman of the Board of Directors, HeartFlow. “Tim’s background and expertise in financial strategy, operations and stewardship will add important perspectives to the Board as we enter our next phase of growth.”

Mr. Barabe brings more than 30 years of experience in the life sciences industry, across a broad range of financial and strategic roles. Most recently, Mr. Barabe served as the chief financial officer and executive vice president at Affymetrix Inc., where he led the company’s financial functions as well as the treasury, investor relations, and information technology departments. Previously, he served as senior vice president and chief financial officer at Human Genome Sciences, where he worked with the leadership team to drive the financial strategy and operations of the company. For more than 20 years, he held senior international executive roles in finance, general management, and strategic planning at Novartis AG. His roles included chief financial officer of the Sandoz Generics Business Unit, president of the CIBA Vision Corporation Specialty Lens Business Franchise, and group vice president and chief financial officer of CIBA Vision Corporation.

Mr. Barabe currently serves as a Board member and Audit Committee Chair of Selecta Biosciences, Inc., and on the board of Vigilant Biosciences, a privately-held medical device company. He previously served on the Boards of Veeva Systems, Inc., ArQule, Opexa Therapeutics, Autonomous Technologies and BioCure, Inc. As an active philanthropist, Tim is involved in a range of charitable causes and served on the board of Project Open Hand, a San Francisco-based non-profit organization focused on serving nutritious meals to vulnerable populations from 2014 to 2020.

“I am thrilled to join the Board of Directors for HeartFlow as the company is at a key inflection point in its growth trajectory,” said Barabe. “I look forward to leveraging my experience and working with the team to make HeartFlow’s game-changing technology broadly available to more patients worldwide.”

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Mr. Barabe has a Bachelor of Business Administration in finance from the University of Massachusetts (Amherst) and an MBA from the University of Chicago.

About the HeartFlow FFRct Analysis

Starting with a standard coronary computed tomography angiogram (CTA), the HeartFlow Analysis leverages algorithms trained using deep learning (a form of AI) and highly trained analysts to create a digital, personalized 3D model of the heart. The HeartFlow Analysis then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow and provides FFRct values along the coronary arteries. This information is used by physicians in evaluating the impact a blockage may be having on blood flow and determine the optimal course of treatment for each patient. A positive FFRct value (≤0.80) indicates that a coronary blockage is impeding blood flow to the heart muscle to a degree which may warrant invasive management.

Data demonstrating the safety, efficacy and cost-effectiveness of the HeartFlow Analysis have been published in more than 500 peer-reviewed publications, including long-term data out to five years. The HeartFlow Analysis offers the highest diagnostic performance available from a non-invasive test.1 To date, clinicians around the world have used the HeartFlow Analysis for more than 100,000 patients to aid in the diagnosis of heart disease.

About HeartFlow

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HeartFlow is the leader in revolutionizing precision heart care, uniquely combining human ingenuity with advanced technology. HeartFlow’s non-invasive HeartFlow FFRct Analysis leverages artificial intelligence to create a personalized three-dimensional model of the heart. Clinicians can use this model to evaluate the impact a blockage has on blood flow and determine the best treatment for patients. HeartFlow’s technology is reflective of our Silicon Valley roots and incorporates over two decades of scientific evidence with the latest advances in artificial intelligence. The HeartFlow FFRct Analysis is commercially available in the United States, UK, Canada, Europe and Japan. For more information, visit www.heartflow.com.

Important Information about the Business Combination and Where to Find It

In connection with the proposed Business Combination pursuant to the business combination agreement, dated as of July 15, 2021 (as amended, the “Business Combination Agreement”), by and among Longview Acquisition Corp. II (“Longview”), HF Halo Merger Sub, Inc. and HeartFlow Holding, Inc., the parent company of HeartFlow, Inc., Longview has filed with the Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4 (the “Registration Statement”), which includes a preliminary proxy statement/prospectus and, as amended, will include a definitive proxy statement/prospectus, and certain other related documents, which will be both the proxy statement to be distributed to holders of shares of Longview’s common stock in connection with Longview’s solicitation of proxies for the vote by Longview’s stockholders with respect to the Business Combination and other matters as may be described in the Registration Statement, as well as the prospectus relating to the offer and sale of the securities of Longview to be issued in the Business Combination. Longview’s stockholders and other interested persons are advised to read the preliminary proxy statement/prospectus included in the Registration Statement and the amendments thereto and the definitive proxy statement/prospectus, as well as other documents filed with the SEC in connection with the proposed Business Combination, as these materials will contain important information about the parties to the Business Combination Agreement, Longview and the proposed Business Combination. After the Registration Statement is declared effective, the definitive proxy statement/prospectus and other relevant materials for the proposed Business Combination will be mailed to stockholders of Longview as of a record date to be established for voting on the proposed Business Combination and other matters as may be described in the Registration Statement. Stockholders will also be able to obtain copies of the preliminary proxy statement/prospectus, the definitive proxy statement/prospectus, and other documents filed with the SEC that will be incorporated by reference therein, without charge, once available, at the SEC’s web site at www.sec.gov, or by directing a request to: Longview Acquisition Corp. II, 767 Fifth Avenue, 44th Floor, New York, NY 10153, Attention: Mark Horowitz, Chief Financial Officer or to [email protected].

Participants in the Solicitation

Longview and its directors and executive officers may be deemed participants in the solicitation of proxies from Longview’s stockholders with respect to the Business Combination. A list of the names of those directors and executive officers and a description of their interests in Longview is contained in the Registration Statement for the Business Combination and is available free of charge at the SEC’s web site at www.sec.gov, or by directing a request to Longview Acquisition Corp. II, 767 Fifth Avenue, 44th Floor, New York, NY 10153, Attention: Mark Horowitz, Chief Financial Officer or to [email protected]. Additional information regarding the interests of such participants is contained in the Registration Statement.

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HeartFlow and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the stockholders of Longview in connection with the Business Combination. A list of the names of such directors and executive officers and information regarding their interests in the Business Combination is contained in the Registration Statement.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. HeartFlow’s actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “indicate,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, HeartFlow’s statements regarding the anticipated Business Combination. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside Longview’s and HeartFlow’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the ability of Longview and HeartFlow prior to the Business Combination, and the combined company following the Business Combination, to meet the closing conditions in the Business Combination Agreement, including due to failure to obtain approval of the stockholders of Longview and HeartFlow or certain regulatory approvals, or failure to satisfy other conditions to closing in the Business Combination Agreement; (2) the occurrence of any event, change or other circumstances, including the outcome of any legal proceedings that may be instituted against Longview and HeartFlow following the announcement of the Business Combination Agreement and the transactions contemplated therein, that could give rise to the termination of the Business Combination Agreement or could otherwise cause the transactions contemplated therein to fail to close; (3) the inability to obtain or maintain a stock exchange listing of the combined company’s Class A common stock, as applicable, following the Business Combination; (4) the risk that the Business Combination disrupts current plans and operations as a result of the announcement and consummation of the Business Combination; (5) the inability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition and the ability of the combined company to grow and manage growth profitably and retain its key employees; (6) costs related to the Business Combination; (7) changes in applicable laws or regulations or the healthcare industry; (8) the inability of the combined company to raise financing in the future; (9) the success, cost and timing of HeartFlow’s and the combined company’s product development activities, including market adoption of their current and future products; (10) the inability of HeartFlow or the combined company to obtain and maintain regulatory approval for their current and future products, and any related restrictions and limitations of any approved product; (11) the inability of HeartFlow or the combined company to build effective sales and marketing capabilities to support the combined company’s growth strategy; (12) the inability of HeartFlow or the combined company to maintain HeartFlow’s existing customer, license, and collaboration agreements, and arrangements with commercial and government payers; (13) future changes in clinical guidelines, or the timing of increased adoption and use, if any, of HeartFlow’s products as a result of the publication of positive clinical guidelines that support the use of HeartFlow’s and the combined company’s products; (14) the inability of HeartFlow or the combined company to compete with other companies marketing or engaged in the development of products that aid physicians in the evaluation and treatment of coronary artery disease; (15) the size and growth potential of the markets for HeartFlow’s and the combined company’s products, and each of their ability to serve those markets, either alone or in partnership with others; (16) the pricing of HeartFlow’s and the combined company’s products and reimbursement for medical procedures conducted using HeartFlow’s and the combined company’s products, including future changes to or reductions in reimbursement and payment rates; (17) HeartFlow’s and the combined company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; (18) HeartFlow’s and the combined company’s financial performance; (19) the impact of COVID-19 on HeartFlow’s business and/or the ability of the parties to complete the Business Combination; and (20) other risks and uncertainties indicated from time to time in the proxy statement/prospectus relating to the Business Combination, including those under “Risk Factors” in the Registration Statement, and in Longview’s other filings with the SEC.

The foregoing list of factors is not exclusive. and investors should not place undue reliance upon any forward-looking statements, which speak only as of the date made. Neither HeartFlow nor Longview undertakes or accepts any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in their expectations or any change in events, conditions or circumstances on which any such statement is based.

No Offer or Solicitation

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This communication shall not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Business Combination. This communication shall also not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act of 1933, as amended.

Contact

For Investors:
Leigh Salvo or Jack Droogan
Gilmartin Group        
[email protected]

For Media:
Jennie Kim
HeartFlow
[email protected]

  1. Driessen, R., et al. J Am Coll Cardiol. 2019;73(2),161-73

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Artificial Intelligence

How AIoT shapes the future of mobility: Hikvision at ITS World Congress 2024

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HANGZHOU, China, Sept. 27, 2024 /PRNewswire/ — Hikvision made a significant impact at the ITS World Congress in Dubai with its captivating theme, “Embrace AIoT for safer, smarter, and greener mobility.” Its booth became a hub of innovation, where visitors explored AIoT solutions that are reshaping the transportation landscape, sparking deep conversations on the future of urban mobility.

Road safety revolution: harnessing AIoT for secure transportation
Hikvision’s commitment to road safety was on full display at its booth through the impressive array of AIoT solutions designed to create secure and reliable traffic environments. The company’s technology provides 24/7 traffic monitoring, ensuring continuous oversight of motor vehicles, non-motorized vehicles, pedestrians and environmental factors. This comprehensive, real-time information collection enables traffic managers to prevent accidents and enhance road safety. Among the showcased products was the 20 MP IR ANPR Checkpoint Capture Unit, renowned for its high-definition capture capabilities, bolstering traffic safety measures.
A standout innovation was the integration of advanced radar and camera technologies, ensuring uninterrupted, comprehensive detection even in adverse weather conditions. The Radar-Video Fusion Incident Detection Cameras, featured prominently in the product experience area, enable early detection and warning of potential hazards. They are particularly effective in challenging situations such as curved roads, blind spots at intersections, and obstacles beyond visual range.
Attendees also engaged with onboard monitoring products on the simulated bus, including dome network cameras, which is designed to enhance passenger safety. Driving assistance products, such as the Driver Status Monitor (DSM), were demonstrated to mitigate unsafe driving behaviors and ensure safer journeys.
Urban mobility redefined: smart traffic innovations
In the realm of smarter mobility, Hikvision showcased its multidimensional sensing technology, which integrates visible light sensors, infrared sensors, radar, and sonar. This technology expands perception capabilities, significantly improving traffic management and situational awareness. The use of AI-powered comprehensive sensing elevates incident monitoring and violation detection to unprecedented levels of accuracy and efficiency.
A major attraction was the Radar-Video Fusion TandemVu PTZ Camera, which integrates millimeter-wave radar with high-resolution cameras for extensive traffic detection and data analysis. AI-based algorithms combine these two systems to enhance target information, detecting up to 16 types of incidents. This leads to the development of a large-scale fusion model that merges spatial physical data with image semantic information. The result is ultra-long-range perception, achieving over 95% accuracy in vehicle trajectory detection. This robust system improves traffic violation management and optimizes traffic flow, significantly enhancing road efficiency.
At the simulated bus station, visitors observed how AI-assisted people counting automated the collection of passenger flow statistics at peak stop hours and bus line frequency during busy periods. Paired with smart bus stop digital signage, the solution improves bus service quality, operational efficiency, passenger experience, and overall public transport effectiveness.
Sustainable transportation: leading the charge for greener cities
Hikvision’s commitment to sustainable urban mobility was evident through its innovative green wave technology and eco-friendly checkpoint solutions. Green wave technology efficiently manages traffic flow to reduce congestion and lower carbon emissions, aligning with global sustainability goals. Visitors were particularly impressed by a case study showcasing a green wave solution implemented in Zhoushan, China. Over a stretch of 21 kilometers and 34 intersections, this main road cut travel times by 50%.
The use of DarkFighterX technology in checkpoint cameras also received significant attention. This technology senses both visible and invisible light, resulting in more accurate and realistic images. It enhances traffic violation enforcement efficiency while minimizing the need for high ambient light levels, thus reducing light pollution. The 9M DarkfightX ANPR Checkpoint Camera exemplified this dedication to environmental stewardship.
Frank Zhang, President of Hikvision MEA, remarked, “Hikvision supports sustainable urban planning by empowering traffic departments to address congestion and transportation challenges.” He further emphasized, “Our system’s openness fosters a secure and reliable platform for developing smart and green cities. Additionally, our solar technology is extensively utilized in remote areas, while our smart street lighting solutions reduce energy consumption by 20-30%, promoting intelligent urban transportation and advancing global sustainability objectives.”
Hikvision’s presence at the ITS World Congress in Dubai underscored its leadership in integrating AIoT technologies to drive safer, smarter, and greener mobility solutions. The engaging presentations and advanced product demonstrations captured significant attention from industry partners and customers, reaffirming the company’s role as a pioneer in shaping the future of urban transportation. As the world moves towards more intelligent and sustainable transportation systems, Hikvision remains at the forefront, embracing AIoT to create a safer, smarter, and greener future for all.
To find out more about Hikvision’s advanced traffic and public transport solutions, please explore the Hikvision official website.
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Artificial Intelligence

Anti-Drone Market worth $7.05 billion by 2029 – Exclusive Report by MarketsandMarkets™

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DELRAY BEACH, Fla., Sept. 27, 2024 /PRNewswire/ — The global anti-drone market was valued at USD 2.16 billion in 2024 and is projected to reach USD 7.05 billion by 2029; it is expected to register a CAGR of 26.7% during the forecast period according to a new report by MarketsandMarkets™. Increasing government spending on counter-drone technologies, rising incidence of critical infrastructure security breaches by unauthorized drones, and surge in adoption of aerial remote sensing technologies to safeguard critical infrastructure are attributed to the demand for anti-drone.

Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=177013645
Browse in-depth TOC on “Anti-Drone Market” 178 – Tables61 – Figures253 – Pages
Anti-Drone Market Report Scope:
Report Coverage
Details
Market Revenue in 2024
$ 2.16 billion
Estimated Value by 2029
$ 7.05 billion
Growth Rate
Poised to grow at a CAGR of 26.7%
Market Size Available for
2020–2029
Forecast Period
2024–2029
Forecast Units
Value (USD Million/Billion)
Report Coverage
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered
By System Type, Application, Platform type, Vertical, and Region
Geographies Covered
North America, Europe, Asia Pacific, and Rest of World
Key Market Challenge
Vulnerability to hacking
Key Market Opportunities
Emphasis on improving unmanned aircraft systems technology
Key Market Drivers
Growing number of illicit activities
By System Type: Hybrid systems to account for the larger market share in the forecasted year.
The hybrid segment accounted for the largest share of the anti-drone market in 2029. The trends of integrating multiple anti-drone technologies are rising since they are most effective in detecting, tracking, and neutralizing drone threats. These systems merge electronic, kinetic, and lasers, providing a comprehensive defense solution against UAVs. Hybrid systems use electronic, kinetic, and laser-based countermeasures to offer optimum protection against drones. These systems are designed to detect, track, identify, categorize, and mitigate drones at operational wide ranges ranging from a few km up to tens of km.
By Platform: The ground-based segment accounted for the largest market share in the forecast year.
The ground-based segment will hold a major share of the anti-drone market in 2029. Many ground-based anti-drone systems use several electronic technologies, such as radar, IR sensors, acoustic systems, and RF & GNSS jammers. MESA radar solutions are used mostly for counter-UAS purposes, protecting critical infrastructure, military camps, and other security-sensitive sites from unauthorized drones. One such solution is EchoGuard, a ground-based airspace management solution that contains a software-defined 3D radar that can be specific to the site. This system can identify single or multiple off-chance drones, including swarms in unauthorized areas. They provide accurate and sustained airspace surveillance for the field of view (FOV) they are configured, and both human and AI-monitored visual checks. The system can be easily transported and integrated directly with the command-and-control centers or another identification sensor for portable use, and multiple units of the system can be combined to cover vast areas or lengths of borders. Major providers of ground-based counter-drone systems include companies like EchoDyne Corporation, DeTect, Meteksan Defense, and WhiteFox Defense. Acoustics-based Discovair G2 utilizes patented microphone arrays. With 128 interconnected microphone elements, the Discovair sensor units can establish azimuth and elevation to the target in real-time using advanced digital signal processing.
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By Region: Americas are expected to hold the largest share of the anti-drone market during the forecast period.
Americas is expected to capture the largest share in the anti-drone industry during the forecast period. The growth can be attributed to protecting crucial infrastructure in the region. Governments, particularly in the US, invest in anti-drone systems for military bases, borders, and critical infrastructure. For Instance, in April 2023, RTX secured a USD 237 million contract from the US Army to provide Ku-band Radio Frequency Sensors (KuRFS) and Coyote effectors. These systems are designed to detect and neutralize unmanned aircraft systems (UAS). The contract includes stationary and mobile systems and a specified quantity of effectors, all aimed at enhancing the Army’s operations within the US Central Command region.
Key Players-
The key companies offering anti-drone companies include RTX (US), Lockheed Martin Corporation (US), Leonardo S.p.A. (Italy), Thales (France), and IAI (Israel).
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Browse Adjacent Market: Semiconductor and Electronics Market Research Reports &Consulting
Related Reports: 
Drone Sensor Market Size, Share, Industry Growth & Trends by Sensor Type, Platform (VTOL Type, Fixed Wing Type, Hybrid Type), Application (Navigation, Collision Detection & Avoidance, Data Acquisition, Motion Detection, Power Monitoring), End Users and Region – Global Forecast to 2029
Smart Agriculture Market Size, Share, Statistics and Industry Growth Analysis Report by Offering (Hardware, Software, Services), Agriculture Type, Farm Size (Large, Medium, Small), Application (Precision Farming, Livestock Monitoring) and Region (America, Europe, Asia Pacific, Row) – Global Forecast to 2028
About MarketsandMarkets™
MarketsandMarkets™ has been recognized as one of America’s best management consulting firms by Forbes, as per their recent report.
MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. We have the widest lens on emerging technologies, making us proficient in co-creating supernormal growth for clients.
Earlier this year, we made a formal transformation into one of America’s best management consulting firms as per a survey conducted by Forbes.
The B2B economy is witnessing the emergence of $25 trillion of new revenue streams that are substituting existing revenue streams in this decade alone. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.
Built on the ‘GIVE Growth’ principle, we work with several Forbes Global 2000 B2B companies – helping them stay relevant in a disruptive ecosystem. Our insights and strategies are molded by our industry experts, cutting-edge AI-powered Market Intelligence Cloud, and years of research. The KnowledgeStore™ (our Market Intelligence Cloud) integrates our research, facilitates an analysis of interconnections through a set of applications, helping clients look at the entire ecosystem and understand the revenue shifts happening in their industry.
To find out more, visit www.MarketsandMarkets™.com or follow us on Twitter, LinkedIn and Facebook.
Contact: Mr. Rohan SalgarkarMarketsandMarkets™ INC. 1615 South Congress Ave.Suite 103, Delray Beach, FL 33445USA: +1-888-600-6441Email: [email protected] Our Web Site: https://www.marketsandmarkets.com/Research Insight: https://www.marketsandmarkets.com/ResearchInsight/anti-drone-market.aspContent Source: https://www.marketsandmarkets.com/PressReleases/anti-drone.asp
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Artificial Intelligence

CluePoints Launches Medical & Safety Review (MSR) Software to Revolutionize Clinical Data Review

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CluePoints furthers its commitment to delivering innovative solutions that enhance clinical trial efficiency with this latest addition to its enterprise software platform.
KING OF PRUSSIA, Pa., Sept. 27, 2024 /PRNewswire/ — CluePoints continues to transform clinical trial review and leverage its industry-leading software to enhance the interrogation, analysis and presentation of data with the launch of its latest application, Medical & Safety Review (MSR).

The tool simplifies and streamlines the medical analysis of study data through user-friendly dashboards, data manipulation and cleaning, query management and full transparency over the data history. This not only improves efficiency and communication in medical oversight, but also elevates patient safety, differentiating MSR as a smarter and unique solution.
Designed by, and for Medical and Safety Reviewers, MSR converts the manual analysis of patient outcomes, which can be prone to inefficiency and error, into an accurate, efficient process. MSR tackles time-consuming study preparation for specific visualizations by featuring a comprehensive standard visualization library as well as the ability to copy and reuse dashboards across different studies, enabling the identification of outlying values, change tracking, and improved communication for smarter clinical trials.
Other benefits of MSR include:
Enhanced medical review efficiency and reduced human errors via automated checksReduced time spent by clinical and data management teams in reviewing dataImproved collaboration with integrated review workflows across departmentsEnsured record quality and accountability with comprehensive change trackingDriving faster decision making with the proactive detection of trends and safety issuesEnsuring regulatory compliance with rule-based detection and user assignmentsAndy Cooper, Chief Executive Officer at CluePoints, commented, “We are thrilled to announce the launch of Medical & Safety Review to our growing product offerings. MSR is the latest application addition to the CluePoints platform, which includes products such as Risk-Based Quality Management (RBQM) and our Site Profile & Oversight Tool (SPOT). Together, they provide a comprehensive approach to clinical trial optimization, enhancing data integrity, ensuring regulatory compliance, and accelerating drug development. The creation of MSR ensures a more streamlined review process while prioritizing patient safety at every step and empowers medical teams to swiftly identify outliers, track data changes, and improve communication.”
To learn more about CluePoints’ award-winning solutions, please visit www.cluepoints.com
About CluePoints
CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. We are leveraging the potential of Artificial Intelligence using Advanced Statistics and Machine Learning to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation, you now have everything you need to adhere with global regulatory guidance. The result is positive clinical development outcomes, increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.
 

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