Artificial Intelligence
Spectral MD Holdings, Ltd. (“Spectral MD” or the “Company”) ISO 13485 Certification Received for AI-Driven DeepView® Wound Imaging System
LONDON and DALLAS, Aug. 14, 2023 (GLOBE NEWSWIRE) — Spectral MD Holdings, Ltd. (AIM: SMD), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, announces that it has received ISO 13485 certification for the manufacture and distribution of its AI-driven DeepView® Wound Imaging System which is designed to provide immediate, accurate, and binary wound treatment assessments for Burn and Diabetic Foot Ulcer (DFU) indications.
ISO 13485 is an internationally recognized standard that ensures the quality of medical device design, development, and production. To receive certification, organizations must demonstrate that their Quality Management Systems (QMS) deliver medical devices and related services that consistently meet stringent customer and regulatory requirements. Spectral MD’s receipt of ISO 13485 certification follows the completion of a comprehensive audit of the Company’s QMS undertaken by an Independent Registrar earlier this year.
Niko Pagoulatos, Chief Operating Officer of Spectral MD, said: “The receipt of ISO 13485 confirms Spectral MD’s status as a global provider of medical devices that meet the highest standards of quality, reliability, and safety. We believe that this acknowledgement reflects Spectral MD’s commitment to fostering a culture of continuous improvement, validates the robust sourcing and operational framework we have created, and provides an important competitive advantage as we continue our regulatory submission initiatives and advance towards product commercialization.”
Spectral MD’s DeepView Wound Imaging System – which received Breakthrough Device Designation from the U.S. Food and Drug Administration (“U.S. FDA”) in 2018 for its Burn indication – integrates optical technology and AI-enabled algorithms using a proprietary database of over 263 billion clinically-validated data points to see deep below the skin’s surface to distinguish between healthy and damaged tissue. The DeepView platform is designed to address a large unmet clinical need by delivering an immediate, informed, and binary AI-driven wound healing assessment that assists physicians in determining whether a burn will heal on its own or if surgery is required.
About Spectral MD
Spectral MD is a predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care for burn, DFU, and future clinical applications. At Spectral MD, we are a dedicated team of forward-thinkers striving to revolutionize the management of wound care by “Seeing the Unknown”® with our DeepView® Wound Diagnostics System. The Company’s DeepView® platform is a predictive diagnostic device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results that have a goal of substantially exceeding the current standard of care in the future, Spectral MD’s diagnostic platform is expected to provide faster and more accurate treatment insight and improve patient care while reducing healthcare costs. For more information, visit the Company at: www.spectralmd.com.
As announced on April 11, 2023, Spectral MD Holdings has entered into a business combination agreement to combine with Rosecliff Acquisition Corp I (“Rosecliff”, Nasdaq: RCLF), a special purpose acquisition company listed on Nasdaq.
Additional Information and Where to Find It
This press release is provided for informational purposes only and contains information with respect to a proposed business combination among Spectral MD, Rosecliff, Ghost Merger Sub I Inc., a wholly-owned subsidiary of Rosecliff and Ghost Merger Sub II LLC, a wholly-owned subsidiary of Rosecliff (the “Transaction”). In connection with the proposed Transaction, Rosecliff filed with the U.S. Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4, which includes a preliminary proxy statement/prospectus (as amended from time to time, the “Registration Statement”). A full description of the proposed Transaction has been included in the Registration Statement filed by Rosecliff with the SEC. Rosecliff’s stockholders, investors and other interested persons are advised to read the Registration Statement as well as other documents that have been filed or will be filed with the SEC, as these documents will contain important information about Rosecliff, Spectral MD, and the proposed Transaction. The Registration Statement has not yet been declared effective by the SEC. If and when the Registration Statement is declared effective by the SEC, the proxy statement/prospectus and other relevant documents for the proposed Transaction will be mailed to stockholders of Rosecliff as of a record date to be established for voting on the proposed Transaction. Rosecliff investors and stockholders will also be able to obtain copies of the proxy statement/prospectus and other documents filed with the SEC, without charge, once available, at the SEC’s website at www.sec.gov.
Participants in the Solicitation
Rosecliff, Spectral MD and certain of their respective directors, executive officers, other members of management and employees may, under SEC rules, be deemed participants in the solicitation of proxies from Rosecliff’s stockholders with respect to the proposed Transaction. Investors and security holders may obtain more detailed information regarding the names and interests in the proposed Transaction of Rosecliff’s directors and officers in Rosecliff’s filings with the SEC, including Rosecliff’s definitive proxy statement, the Registration Statement and other documents filed with the SEC. Such information with respect to Spectral MD’s directors and executive officers has also been included in the Registration Statement.
No Offer or Solicitation
This press release and the information contained herein do not constitute (i) (a) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed Transaction or (b) an offer to sell or the solicitation of an offer to buy any security, commodity or instrument or related derivative, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction or (ii) an offer or commitment to lend, syndicate or arrange a financing, underwrite or purchase or act as an agent or advisor or in any other capacity with respect to any transaction, or commit capital, or to participate in any trading strategies. No offer of securities in 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 (the “Securities Act”) shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act, or an exemption therefrom. Investors should consult with their counsel as to the applicable requirements for a purchaser to avail itself of any exemption under the Securities Act.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. This includes, without limitation, all statements regarding (i) the proposed Transaction with Rosecliff, including statements regarding anticipated timing of the proposed Transaction, (ii) redemptions of Rosecliff common stock, (iii) valuation of the proposed Transaction, (iv) the closing of the proposed Transaction, (v) the ability to regain compliance with Nasdaq Capital Market listing requirements and to maintain listing, or for the Combined Company to be listed, on the Nasdaq Capital Market, (vi) Rosecliff and Spectral MD’s managements’ expectations and expected synergies of the proposed Transaction and the Combined Company, (vii) the use of proceeds from the proposed Transaction, (viii) potential government contracts, and (ix) expected beneficial outcomes and synergies of the proposed Transaction, (x) Spectral MD’s U.S. government contracts and future awards, (xi) FDA, CE and UKCA regulatory submissions and approvals, (xii) target markets of burn wounds and diabetic foot ulcers, (xiii) possible competitors, (xiv) future clinical indications and use of BARDA, (xv) potential PIPE transaction and amount raised, (xvi) future applications of Spectral MD products, (xvii) potential indications and areas of interest supported by BARDA, (xviii) future and pending U.S. patent applications and foreign and international patent applications, (xvix) the AIM delisting and its effects for U.K. Spectral MD shareholders, (xxx) the development of DeepView® technology and tools; (xxxi) the effectiveness of the DeepView® platform in assessing burn wounds, (xxxii) the reliability of any studies performed by Spectral MD, and (xxxiii) the completion of any certifications. Generally, statements that are not historical facts, including statements concerning our possible or assumed future actions, business strategies, events or results of operations, are forward-looking statements. These statements may be preceded by, followed by or include the words “believes,” “estimates,” “expects,” “projects,” “forecasts,” “may,” “will,” “should,” “seeks,” “plans,” “scheduled,” “anticipates” or “intends” or similar expressions. Such forward-looking statements involve risks and uncertainties that may cause actual events, results or performance to differ materially from those indicated by such statements. These forward-looking statements are expressed in good faith, and Spectral MD and Rosecliff believe there is a reasonable basis for them. However, there can be no assurance that the events, results or trends identified in these forward-looking statements will occur or be achieved. Forward-looking statements speak only as of the date they are made, and neither Spectral MD nor Rosecliff is under any obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
Forward-looking statements are inherently subject to risks, uncertainties and assumptions. In addition to risk factors previously disclosed in Rosecliff’s reports filed with the SEC and those identified elsewhere in this press release, the following factors, among others, could cause actual results to differ materially from forward-looking statements or historical performance: (i) risks associated with product development and regulatory review, including the time, expense and uncertainty of obtaining clearance, approval or De Novo classification for Spectral MD’s DeepView technology, (ii) Spectral MD’s ability to obtain additional funding when needed and its dependence on government funding, (iii) expectations regarding Spectral MD’s strategies and future financial performance, including its future business plans or objectives, prospective performance and opportunities and competitors, revenues, products and services, pricing, operating expenses, market trends, liquidity, cash flows and uses of cash, capital expenditures, and Spectral MD’s ability to invest in growth initiatives and pursue acquisition opportunities; (iv) the risk that the proposed Transaction may not be completed in a timely manner at all, which may adversely affect the price of Rosecliff’s securities; (v) the failure to satisfy the conditions to the consummation of the proposed Transaction, including the adoption of the business combination agreement by the stockholders of Rosecliff and the stockholders of Spectral MD, and the receipt of certain governmental and regulatory approvals; (vi) the lack of third party valuation in determining whether or not to pursue the proposed Transaction; (vii) the ability of Rosecliff to regain compliance with Nasdaq Capital Market listing requirements and to maintain listing, or for the Combined Company to be listed, on the Nasdaq Capital Market; (viii) the occurrence of any event, change or other circumstances that could give rise to the termination of the business combination agreement; (ix) the outcome of any legal proceedings that may be instituted against Rosecliff or Spectral MD following announcement of the proposed Transaction; (x) the risk that the proposed Transaction may not be completed by Rosecliff’s business combination deadline and the potential failure to obtain an extension of the business combination deadline; (xi) the effect of the announcement or pendency of the proposed Transaction on Spectral MD’s business relationships, operating results, and business generally; (xii) volatility in the price of Rosecliff’s securities due to a variety of factors, including changes in the competitive and regulated industries in which Rosecliff plans to operate or Spectral MD operates, variations in operating performance across competitors, changes in laws and regulations affecting Rosecliff’s or Spectral MD’s business, Spectral MD’s inability to implement its business plan or meet or exceed its financial projections and changes in the combined capital structure; (xiii) Rosecliff’s ability to raise capital as needed; (ixv) the ability to implement business plans, forecasts, and other expectations after the completion of the proposed Transaction and identify and realize additional opportunities; (xv) the risk that the announcement and consummation of the proposed Transaction disrupts Spectral MD’s current operations and future plans; (xvi) the ability to recognize the anticipated benefits of the proposed Transaction; (xvii) unexpected costs related to the proposed Transaction; (xviii) the amount of any redemptions by existing holders of the Rosecliff common stock being greater than expected; (xix) limited liquidity and trading of Rosecliff’s securities; (xx) geopolitical risk and changes in applicable laws or regulations; (xxi) the possibility that Rosecliff and/or Spectral MD may be adversely affected by other economic, business, and/or competitive factors; (xxii) operational risk; and (xxiii) changes in general economic conditions, including as a result of the COVID-19 pandemic. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” sections of the Rosecliff’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, the Registration Statement and the other documents filed by Rosecliff from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.
Readers are cautioned not to put undue reliance on forward-looking statements, and neither Spectral MD nor Rosecliff assumes any obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by securities and other applicable laws. Neither Spectral MD nor Rosecliff gives any assurance that it will achieve its expectations.
For further information please contact:
| Spectral MD Holdings, Ltd. | [email protected] | |
| Christine Marks, VP of Marketing and Commercialization | ||
| SP Angel Corporate Finance LLP (NOMAD and Joint Broker for Spectral MD) | Tel: +44 (0)20 3470 0470 | |
| Stuart Gledhill / Harry Davies-Ball (Corporate Finance) Vadim Alexandre / Rob Rees (Sales & Broking) |
||
| The Equity Group Inc. (US Investor Relations) | [email protected] | |
| Devin Sullivan, Managing Director | Tel: 212-836-9608 | |
| Walbrook PR Ltd (UK Media & Investor Relations) | [email protected] | |
| Paul McManus / Louis Ashe-Jepson /Alice Woodings | Tel: +44 (0)20 7933 8780 | |
Artificial Intelligence
How AIoT shapes the future of mobility: Hikvision at ITS World Congress 2024
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™
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.
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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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About MarketsandMarkets™
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Artificial Intelligence
CluePoints Launches Medical & Safety Review (MSR) Software to Revolutionize Clinical Data Review
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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