From Point-in-time to Real-time
Pharmaceutical Commerce
JUNE 10, 2022
Why ‘real-time-all-the-time’ supply chain operations are fundamental to biopharma success.
from-point-in-time-to-real-time 
Planning for Complex Change at Your Organization
Advarra
APRIL 25, 2024
Current State Assessment Assessing your organization’s current state is a great starting point as you anticipate complex change. However, not much time should be spent in this stage; it should be relatively easy to identify where you’re currently at. The only constant in clinical research is change.
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Tech innovations that curb complexity, setting clinical trials up for success
Pharmaceutical Technology
OCTOBER 26, 2022
Several factors in recent years have contributed to this rise including more complex trial designs, the rapid adoption of decentralisation stemming from the pandemic, and larger global trials. Unplanned protocol deviations, which add time and cost to a study, are also contributors to complexity. Demand planning drives trial efficiency.
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The potential of AI in pharma R&D
Pharmaceutical Technology
JUNE 15, 2023
Successful innovation requires enormous effort from countless project teams that build on the medical, scientific and technological research and development of generations before them. Product management AI in product management can improve every phase of a product, from ideation to development to commercialization.
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Omnichannel is irrelevant with the wrong message
World of DTC Marketing
JANUARY 21, 2022
It is evident that HCPs are extremely time constraint and prefer to engage with pharma organizations on their terms regarding channel, content, and type of devices. It is evident that HCPs are extremely time constraint and prefer to engage with pharma organizations on their terms regarding channel, content, and type of devices.
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How Market Listening Can Help Drive Your Pharma Sales Funnel
Pharma Mirror
APRIL 14, 2021
The role of pharma sales reps is an incredibly important part of this lifecycle from initial research to point of sale and distribution, with reps connecting the groundbreaking research and technology of pharma companies with healthcare professionals and medical establishments. trillion in revenue globally.
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Grand Rounds February 9, 2024: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project (Cynthia Hau, MPH)
Rethinking Clinical Trials
FEBRUARY 14, 2024
It had a pragmatic recruitment model with an embedded design, multicenter study without local study investigators and management teams, and broad recruitment that included patients from all 50 states and Puerto Rico. At the time, more than 95% of VA patients received hydrochlorothiazide for thiazide-type diuretic.
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Leveraging AI-Enabled Data Extraction to Accelerate Case Processing in Clinical Trials
Cloudbyz
FEBRUARY 29, 2024
In the dynamic landscape of pharmacovigilance, where timely and accurate data processing is paramount, the integration of artificial intelligence (AI) technologies has emerged as a game-changer. In this blog, we delve into the potential of AI in pharmacovigilance and its implications for clinical trial safety monitoring.
Leveraging AI-Enabled Data Extraction to Accelerate Case Processing in Clinical Trials
Cloudbyz
FEBRUARY 29, 2024
In the dynamic landscape of pharmacovigilance, where timely and accurate data processing is paramount, the integration of artificial intelligence (AI) technologies has emerged as a game-changer. In this blog, we delve into the potential of AI in pharmacovigilance and its implications for clinical trial safety monitoring.
Pfizer is first big pharma to tap Truveta’s real-world data platform
pharmaphorum
JUNE 22, 2022
Pfizer has harnessed the expertise of health data specialist Truveta to provide close monitoring of safety and other signals for its products, including COVID-19 vaccine Comirnaty, almost in real-time. “We hope to continue to find additional benefit from this growing data such as identifying and addressing health disparities.”
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Quantra Hemostasis System by HemoSonics Gets FDA 510(k) Clearance
XTalks
DECEMBER 8, 2022
The Quantra Hemostasis System with QStat Cartridge is ground-breaking in the field of point-of-care and laboratory-based whole blood hemostasis testing, and the recent clearance expands its indications to now include trauma and liver transplant procedures. Data gathered during point-of-care can aid PBM-guided decisions.
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Tapping into pharma’s growing opportunities in digital health
Pharmaceutical Technology
AUGUST 4, 2022
In addition to doing more to proactively support healthcare providers and patients, digital health opportunities provide a chance for pharma companies to capture (and become a trusted source of) important real-world data about patients’ behaviour and their wider wellbeing. Breaking down the opportunities.
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Comprehensive Guide on Risk-Based Monitoring (RBM)
Cloudbyz
APRIL 8, 2024
By focusing on critical data points and processes, errors and discrepancies are detected and addressed more effectively, reducing the risk of data inaccuracies. Real-Time Data Analysis: RBM relies on real-time data analytics, enabling sponsors to identify and address issues promptly.
In Alzheimer’s Dementia, Should EEG Be Used as a Functional Biomarker of Target Engagement and Organizational Change When Evaluating Treatment Efficacy?
XTalks
APRIL 11, 2024
CJ Barnum, PhD VP of CNS Development INmune Bio Brian Murphy, PhD Co-Founder and CSO Cumulus Neuroscience They also share results from a recent pilot study that used the Cumulus Neuroassessment Platform , which demonstrated the potential of EEG biomarkers in furthering our understanding and treatment of Alzheimer’s disease.
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2024 Food Industry Trends: Navigating the Future of Tech, Sustainability and Nutrition
XTalks
DECEMBER 13, 2023
Here, we delve into the 2024 food industry trends from leading experts in the field, each offering a unique perspective on the trends and challenges that will define the landscape of food production, distribution and consumption in the coming year.
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Looking for a Summer Internship? You’d Better Act Fast
Intouch Solutions
FEBRUARY 25, 2022
Internships are an ideal way to get real work experience and figure out if you’re a good fit for a particular industry, but how do you score one when much of the professional world is still working remotely? — of our interns go on to become full-time Intouchers. — of our interns go on to become full-time Intouchers.
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MolecuLight’s CEO Anil Amlani Discusses Next Steps for Their Wound Imaging Devices
XTalks
AUGUST 22, 2022
Their point-of-care devices allow clinicians to safely visualize the presence and location of high bacterial loads in real time so that clinicians can direct their wound care in the best possible way. Read on to learn more! What is MolecuLight’s mission? In essence, we are providing diagnostic imaging to wound care.
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The Transformative Power of Generative AI in eTMF: Enhancing Efficiency, Quality, and Compliance
Cloudbyz
JUNE 5, 2023
By analyzing document content and metadata, generative AI can accurately determine the appropriate classification, saving significant time and effort for research teams. Intelligent Document Extraction: Extracting critical information from various documents within an eTMF can be a time-consuming and error-prone task.
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Utilising real-time data to improve customer engagement
pharmaphorum
JANUARY 25, 2022
Oskar says OpenData provides their clients with customer reference data that helps interactions be more relevant and personalised with the right message, at the right time, on the right channel to meet HCPs unique needs. And limitations from some data providers on where and how companies can use data hinder rep productivity.
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Grand Rounds August 25, 2023: Pragmatic Trial of an EHR Application to Display Real-time PRO Data: Successes and Challenges (Gabriela Schmajuk, MD, MS)
Rethinking Clinical Trials
AUGUST 30, 2023
Speaker Gabriela Schmajuk, MD, MS Professor of Medicine UCSF and the San Francisco VA Slides Keywords Patient-Reported Outcomes, Rheumatoid Arthritis, EHR Key Points Clinicians rely on patient-related outcomes (PROs) to track disease and function over time in patients with rheumatoid arthritis (RA).
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How to Improve Energy Management in the Food and Beverage Industry
XTalks
OCTOBER 3, 2022
Here are three ways food and beverage companies can improve energy management , from data collection to automated technology. The quickest path to greater profits in the food and beverage industry lies in leveraging real-time energy data to identify energy inefficiencies and waste. . Link Production Data with Energy Data.
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Biogen: This train wreck was due
World of DTC Marketing
DECEMBER 10, 2021
MY POINT : Success is always temporary. Biogen went from being agile biotech to big pharma. Biogen went from being agile biotech to big pharma. To make matters worse, the negative PR and feedback from the medical community around Aduhelm were increasingly hostile. Trouble was on the way, though.
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How hybrid virtual engagement is accelerating oncology communication
pharmaphorum
JULY 19, 2021
COVID has revolutionised the way pharma engages with healthcare stakeholders – but to be truly successful, digital engagement needs to move away from an overreliance on real-time meetings, say experts from Within3. This is despite in-person meetings having many obvious drawbacks.
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Grand Rounds October 6, 2023: Hybrid Studies Should Not Sacrifice Rigorous Methods (David M. Murray, PhD; Moderator: Jonathan Moyer, PhD)
Rethinking Clinical Trials
OCTOBER 11, 2023
Moyer, PhD Statistician, NIH Office of Disease Prevention Slides Keywords Implementation; Study design; Hybrid; Clustered; DECIPHeR Key Points People often contest that hybrid designs are not as rigorous as they should be. One of the key features was that implementation measures were to be used as primary outcomes.
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Nevro’s AI-Based Spinal Cord Stimulation Device for Chronic Pain Receives FDA Approval
XTalks
OCTOBER 18, 2022
According to Nevro, the Senza HFX iQ is the first and only artificial intelligence (AI)-based SCS system that “learns from patients.”. Pain is variable from patient to patient and over time. The pain relief program is directly adjusted on an individual’s IPG from the HFX app without requiring a separate manual remote.
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What Are the Top Oncology Clinical Trial Trends Through the Lens of ESMO?
XTalks
JANUARY 17, 2024
In this Xtalks Spotlight edition, Xtalks spoke with two oncology clinical research experts from Fortrea , Laura Vidal, MD, Medical Head of Oncology, EU (European Union), and Ken Morrison, PhD, Global Head of Strategic Delivery & Growth Oncology. Oncology is recognized as having the largest drug pipeline of any therapeutic area.
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Covid vaccine profits and the strain on supply channels
World of DTC Marketing
JANUARY 8, 2021
Wall Street has been speculating for a long time on which pharma company is going to make the most from the development of a Covid-19 vaccine. At the time, pharmaceutical giant Pfizer and its partner BioNTech—which now have the other US-authorized COVID-19 vaccine—had inked a deal with the US government to supply doses at $19.50
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Web analytics should tell a story
World of DTC Marketing
OCTOBER 30, 2020
However, in a deeper analysis, we have found that each page’s time is too short to read its entire content. 2wo : Shorten page content with callous of important points. 2wo : Shorten page content with callous of important points. Users should not have to scroll more than once to real a page’s content.
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How To Improve Your Study- Startup in Clinical Trials?
Cloudbyz
MARCH 12, 2021
Study startups (SSUs) define the process flow starting from the first point of contact with the sponsor to screening and recruiting process of subjects by study team. However, with time and evolution of the clinical trial , a paradigm shift has been observed in the clinical trial management landscape.
Personalizing the Cancer Patient Journey
Pharma Marketing Network
JULY 27, 2022
In the first two weeks after a cancer diagnosis, there are likely dozens of doctor’s visits, tests, consultations, and decision points. By helping them find relevant resources with highly specific information at the right time and in a chapterized format. Meeting Patients Where They Are. Supporting the Patient Journey.
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Implementing eSource: A Guide for Operations and Technology Roles
Advarra
JANUARY 10, 2024
Eliminating the requirement for manual data transcription leads to significant savings in terms of the costs and time spent on a study. Successfully implementing eSource requires sites to shift from paper-based data to electronic data records in a way to preserve data integrity and patient safety.
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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?
FDA Law Blog
DECEMBER 7, 2022
In simple terms from a non-scientist, these gene therapies add functional versions of genes to patients that do not have them, and thus the idea is to have these genes function in the same way as they do in individuals without these disorders. This product was developed by uniQure prior to being licensed to CSL Behring.
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Modern Solutions for Modern Clinical Trials – The Benefits of Mobile EDC Access
Crucial Data Soutions
MAY 31, 2023
Improvements to data collection technologies and processes, a robust high-speed internet infrastructure, and pressure from regulators to make research more inclusive are converging, making exclusively site-based study designs increasingly rare. They do so, largely, from mobile devices – often their very own smartphones.
Medical affairs in a digital-first world: Benefits and challenges
Pharmaceutical Technology
NOVEMBER 2, 2022
The pharmaceutical community has reached somewhat of a turning point as it commercialises a growing number of speciality medicines relying on complex new treatment pathways. Digital-first medical affairs can help to drive more collaborative projects over a larger geographical footprint, including real-world data initiatives.
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Transforming Clinical Study Build with Generative AI: Automating Data Extraction from Protocol Documents in Cloudbyz EDC
Cloudbyz
SEPTEMBER 19, 2023
The process of building a clinical study can be both time-consuming and error-prone, as it involves extracting essential data from protocol documents and translating it into electronic data capture (EDC) systems like Cloudbyz EDC. Accuracy and Consistency : Human errors are a significant concern in manual data extraction.
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GSK Canada’s New RSV Vaccine Ad Features Wayne Gretzky, Young and Old
XTalks
OCTOBER 31, 2023
Case in point, GSK’s Arexvy, the first approved vaccine for RSV, is currently only approved for adults 60 years of age and older. Case in point, GSK’s Arexvy, the first approved vaccine for RSV, is currently only approved for adults 60 years of age and older. In the ad, Gretzky Jr. asks Gretzky Sr. laughingly replies, “We did OK.”
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Pharma’s ESG goals need to underscore push for health equity
Pharmaceutical Technology
OCTOBER 26, 2022
On October 6, in a GlobalData webinar, experts tried to answer the question ‘ Is Pharma at an ESG turning point?’ , revealing a multitude of diverse strategies for pharmaceutical companies to remain conscious of their global impacts. However, in GlobalData’s 2021 Global Management Insight Survey, 58.4% Reaching social and governance goals.
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In the News: October 2021 Regulatory and Development Updates
Camargo
NOVEMBER 15, 2021
FDA Guidance Addresses Real-World Evidence Data Standards. The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). But what real-world evidence (RWE) would be accepted, and in what format?
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New CGT process analytical technologies lab opens
Drug Discovery World
MARCH 15, 2023
Moving from producing a small quantity of a CGT to producing a larger quantity is often challenging. Moving from producing a small quantity of a CGT to producing a larger quantity is often challenging. These products derive from complex biological materials, which are sensitive to environmental changes.
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Transforming healthcare through sustainable and resilient data infrastructure
pharmaphorum
DECEMBER 20, 2022
To make personalised healthcare a reality, data must be safely and responsibly used in a way that provides real value for patients and the entire healthcare ecosystem. To make personalised healthcare a reality, data must be safely and responsibly used in a way that provides real value for patients and the entire healthcare ecosystem.
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Medicare savings won’t make a dent in healthcare costs
World of DTC Marketing
SEPTEMBER 9, 2021
Chan School of Public Health, says, “at the moment, people are skeptical enough of the pharmaceutical industry that they’re going to have a tough time saying that if the government gets you a discount, you won’t get discoveries.”. The problem is that voters don’t believe that pitch. healthcare. healthcare spending.
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Does Biopharma Drug Discovery Need to Evolve to Include Objective, Longitudinal, Broad-Spectrum Real-World Data?
XTalks
MARCH 19, 2024
It is well established that drugs for psychiatric conditions suffer some of the lowest approval rates when compared to other major therapeutic areas. There are many underlying factors, including complex and poorly understood etiology which are heterogeneous in presentation and presumably underlying pathophysiology.
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Better Data, Better Outcomes: A LexisNexis® Risk Solutions and Q1 Productions Webinar
Drug Channels
DECEMBER 5, 2021
There are many data vendors that can supply the claims information from the day-to-day patient experience. But, how many vendors can target exactly the data you need and alert you in near real-time when those events occur? Better Data, Better Outcomes: A LexisNexis ® Risk Solutions and Q1 Productions Webinar.
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Merck’s Lagevrio ‘no better than placebo’ in COVID hospitalisations
pharmaphorum
OCTOBER 7, 2022
A UK study has found that Merck & Co’s oral COVID-19 therapy Lagevrio was unable to reduce hospitalisations compared to placebo in patients at higher risk from the virus, adding fuel to assertions in some quarters that its authorisation was premature. The European Commission has yet to approve it for use in the EU.
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