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Clinical Data Articles & Analysis

471 news found

Proregulations Launches Comprehensive ANDA Services   

Proregulations Launches Comprehensive ANDA Services  

The ANDA contains information used for the review and approval of a generic drug product, and does not typically require preclinical and clinical trial data, but rather requires the inclusion of information on bioequivalence to the RLD. ...

ByProregulations


SOPHiA Genetics Unveils New Generation of the SOPHiA DDM Platform at Morgan Stanley Healthcare Conference 2024

SOPHiA Genetics Unveils New Generation of the SOPHiA DDM Platform at Morgan Stanley Healthcare Conference 2024

As the volume and utility of data grows, SOPHiA GENETICS continues to accelerate innovation in the field of data-driven medicine by unveiling best-in-class technology and data science capabilities. ...

BySOPHiA Genetics


CanaQuest Announces Key Appointments to Team to Drive CQ-001 through Clinical Trials

CanaQuest Announces Key Appointments to Team to Drive CQ-001 through Clinical Trials

CanaQuest Medical Corp (“CanaQuest” or the “Company”) (OTC: CANQF), is pleased to announce strategic additions to its executive team with expertise in conducting clinical trials and US FDA drug approval success. The team plans to effectively navigate the regulatory approval process for Drug Candidate, CQ-001 (cannabidiol + proprietary API composition), to treat rare ...

ByCanaQuest Medical Corp.


Tempus Announces Expansion of Collaboration with AstraZeneca to Leverage Tempus Next to Support Guideline-directed Biomarker Testing in NSCLC

Tempus Announces Expansion of Collaboration with AstraZeneca to Leverage Tempus Next to Support Guideline-directed Biomarker Testing in NSCLC

In September 2023, Tempus and AstraZeneca initiated a pilot program to leverage Next to identify this specific care gap at participating provider sites, using AI to scan unstructured clinical data to understand which patients may be eligible for testing based on clinical guidelines, and notifying treating physicians to inform care. ...

ByTempus


Comparison of the Rapid Bactericidal Efficacy of Commercially Available Surgical Solutions

Comparison of the Rapid Bactericidal Efficacy of Commercially Available Surgical Solutions

Introduction Intraoperative irrigation is a commonly used method aimed at reducing microbial burden by removing tissue debris, metabolic waste, and tissue exudate from the surgical field prior to site closure.1 With the absence of universally established standard of care and robust clinical data, the selection of appropriate irrigation solution remains a ...

BySanara MedTech Inc.


Caresyntax Announces Highlights of 2023

Caresyntax Announces Highlights of 2023

Caresyntax, the leading vendor of enterprise-scale data-driven surgical intelligence solutions to make surgery safer and smarter, today announced its highlights and achievements of 2023, as the company has continued its strong growth journey. Dennis Kogan, co-founder, and CEO: “Caresyntax celebrated its 10-year anniversary in 2023 and accelerated our journey of innovation ...

ByCaresyntax


Caresyntax Announces Launch of Novel Real World Evidence (RWE) Program and Software Portfolio of Digital Catalysts for Commercial Acceleration of Medtech Partners

Caresyntax Announces Launch of Novel Real World Evidence (RWE) Program and Software Portfolio of Digital Catalysts for Commercial Acceleration of Medtech Partners

Caresyntax, the leading vendor-neutral surgical data and intelligence platform converging AI-powered software, devices, and clinical services, today announced the launch of Caresyntax Clinical Data as a Service (CDaaS) for Medtech industry partners. ...

ByCaresyntax


Caresyntax Announces Strategic Collaboration with AAICO to Expand AI-based Solutions In Healthcare

Caresyntax Announces Strategic Collaboration with AAICO to Expand AI-based Solutions In Healthcare

The collaboration will leverage a secure infrastructure that is compliant with data privacy, information security, and regulatory concerns across the geographies. ...

ByCaresyntax


Caresyntax and Sheba ARC Sign Agreement to Develop the Future Model for Surgical Innovation

Caresyntax and Sheba ARC Sign Agreement to Develop the Future Model for Surgical Innovation

Caresyntax, the leading vendor-neutral enterprise surgical data and intelligence platform designed to make surgery smarter and safer by converging AI-powered software, devices, and clinical services, today announced a partnership with ARC (Accelerate, Redesign, Collaborate) Sheba’s Global Innovation platform to establish and replicate the ARC Surgical ...

ByCaresyntax


Vitalograph expands Clinical Trial services portfolio with centralized DLCO, decentralized spirometry, and integrated oscillometry solutions.

Vitalograph expands Clinical Trial services portfolio with centralized DLCO, decentralized spirometry, and integrated oscillometry solutions.

With more than 60 years’ expertise in respiratory diagnostics, Vitalograph is the only company in the world specialized in delivering clinical trial services exclusively for pulmonary function-focused studies. ...

ByVitalograph Inc


Anuncia Medical Announces the First Successful US Implant of the Company’s Newly Commercially Released ReFlow Mini Flusher Device for Hydrocephalus Patients

Anuncia Medical Announces the First Successful US Implant of the Company’s Newly Commercially Released ReFlow Mini Flusher Device for Hydrocephalus Patients

Noninvasive flushing with the ReFlow Mini Flusher can be performed in-clinic by trained clinical staff, or anywhere by a trained patient/caregiver, as directed by the neurosurgeon. ...

ByAnuncia Medical, Inc.


New data from pivotal studies with aflibercept 8 mg

New data from pivotal studies with aflibercept 8 mg

New Subgroup and further analyses from PULSAR, PHOTON and CANDELA provide insights into durability results of extended treatment intervals, patient characteristics as well as efficacy and safety of intravitreal aflibercept 8 mg In total, 18 presentations on aflibercept 8 mg and Eylea (aflibercept 2 mg) reinforce Bayer’s commitment to advancing treatment of patients with exudative retinal ...

ByBayer AG


New Study Confirms Daxor’s BVA-100 Volume Metric Compared to CardioMEMS Pressure Metric Has Unique Clinical Utility as a Diagnostic for Heart Failure Patients

New Study Confirms Daxor’s BVA-100 Volume Metric Compared to CardioMEMS Pressure Metric Has Unique Clinical Utility as a Diagnostic for Heart Failure Patients

Daxor Corporation (NYSE: DXR), the global leader in blood volume measurement technology, today announces new data validating the benefits of the Company’s BVA-100 diagnostic in optimizing individualized therapy for heart failure patients. Data were presented at the Technology Heart Failure Therapeutics Conference, which focuses on device and ...

ByDaxor Corporation


The Importance of Optimal Medical Therapy (OMT) and Collaborative Care

The Importance of Optimal Medical Therapy (OMT) and Collaborative Care

The HFSA Optimal Medical Therapy in Heart Failure (OMT-HF) program can help your patients achieve their best outcomes. An estimated 6.5 million Americans have heart failure (HF). This year alone another 960,000 will likely be diagnosed with this condition. Chances are several of your patients are in this group. Are they receiving the optimal medical therapy (OMT), that helps them achieve ...

ByHeart Failure Society of America, Inc. (HFSA)


Bayer driving innovation in radiology with new research across the portfolio presented at ECR

Bayer driving innovation in radiology with new research across the portfolio presented at ECR

A key presentation highlights new clinical data on the novel development compound gadoquatrane, a next generation macrocyclic gadolinium-based contrast agent (GBCA) which is currently in Phase II of clinical development and planned to enter Phase III later this year. ...

ByBayer AG


Why Knowledge Is Power In The Treatment Of Obesity

Why Knowledge Is Power In The Treatment Of Obesity

Dr. Ali Tinazli is the CEO of lifespin.health and has 15+ years in Fortune 100 corporate strategy and entrepreneurship (SONY, HP). Obesity rates continue to climb alongside a $254.9 billion global weight loss products and services market. Supplements, smartphone weight loss apps, diet plans and exercise programs are widely available to consumers, yet the World Obesity Federation projects that 1 ...

ByLifespin GmbH


Are you Using the Right KPIs to Measure Success at your Biotech Company?

Are you Using the Right KPIs to Measure Success at your Biotech Company?

This KPI can help Biotech companies understand their current status and future goals. 2. Data Generation: Data generated through different studies, publications and presentations impact clinical practices. Current scientific data, best practices, and patient feedback can be a good indicator of key performance. 3. ...

ByBrio Group


Clinical Trial Managers Need to Know These Skills for the Future

Clinical Trial Managers Need to Know These Skills for the Future

To develop a strong working relationship, the skill of communication is very integral in this profession. Also, sharing information and data between teams and individuals requires much corroboration. The knowledge of skills and tools to connect and corroborate in different ways can help with your personal development. 2: Effective Leadership Clinical trial ...

ByBrio Group


Inspirata Accelerates Its Growth as a Leading Provider of AI/NLP Technology in Oncology Informatics

Inspirata Accelerates Its Growth as a Leading Provider of AI/NLP Technology in Oncology Informatics

Critical workflows in Oncology Informatics, such as clinical trial matching and cancer registry reporting and data abstraction, are ripe for disruption through the powerful and clinically optimized AI (artificial intelligence) and NLP (Natural Language Processing) technology that Inspirata has been developing over two decades. In 2023, Inspirata ...

ByInspirata, Inc


Unbiased gene fusion analysis required in future cancer diagnostics

Unbiased gene fusion analysis required in future cancer diagnostics

Qlucore, trusted by scientists since 2007, provides software packages for clinical RNA-seq data analyses to facilitate classification of cancer patients as well as detailed gene fusion analysis and reporting: Qlucore Insights - already available and used at several customer sites. ...

ByQlucore AB

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