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Quality Management Solutions: Meeting Complex Needs Across Pharma

Kutubkhan Bohari | August 9, 2022 | 1153 views | Read Time : 02:00 min

Quality Management
Introduction
With increasing complexities across the pharmaceutical industry and a rise in novel drug development, drug manufacturing has become one of the most strictly regulated sectors in the past few years. Also, as the emphasis on the declining side effects of various drugs and improving drug effectiveness continues to grow, the importance of enhancing quality is becoming crucial in the life science industries.

Pharmaceutical quality professionals face more obstacles and have more opportunities than ever before to improve the quality and compliance of drugs and bionics. Increasing complexity in supply chains, tightening regulations, and growing data integrity issues are compelling pharmaceutical companies to adopt quality processes and quality management solutions on a day-to-day basis. In addition, regulatory bodies such as the Food and Drug Administration (FDA) and others are increasingly focusing not only on compliance but also on developing a culture of quality management in the pharmaceutical sector.

Why are Pharmaceutical Quality Management Systems Gaining Importance?
Presently, inspectional FDA 483s, import alerts, warning letters, and notices of violations from regulatory authorities are emerging as the biggest obstacles for pharmaceutical manufacturers. The role of quality management systems is of great significance in the pharmaceutical drug manufacturing sectors.

Understanding and implementing an effective quality management system model enables a pharmaceutical organization to meet its regulatory and ethical obligations, which include the management of the quality, efficacy, safety, identity, and purity of finished medicinal products.

Every pharmaceutical industry must adhere to a variety of rules and specifications established by a number of international regulations. A quality management system is used to maintain the quality of pharmaceutical products.  It assists in organizing and managing all records, processes, and workflows, ultimately improving overall product quality. When supported by any IT system or paper-based methodology, it also aids the organization in meeting current and future regulatory standards.

Here are some reasons why quality management systems are so important for pharmaceutical companies

  • Production Investigation
  • Enhancing Manufacturing Efficiency
  • Improving Product Assessment
  • Decreasing Human Errors
  • Compliance with Industry Best Standards
  • Reducing Costs
  • Optimize Processes, Products, and Systems


Data from a quality management system can also be set up in a way that allows for consistent risk calculations, metrics, FDA and ISO compliance, and other trend analysis.

The Way Forward
A quality management system is the core of any quality and assurance (Q&A) and compliance process. It is a regulatory requirement that the Central Drugs Standard Control Organization and other global regulatory bodies consider critical.

With drug approvals getting stricter and new automated manufacturing processes being used, leading pharmaceutical companies are adopting these solutions to cut down on audit time and findings and reduce the risk of product recalls.

Driven by this, the sales of pharmaceutical quality management solutions are estimated to top $2.9 billion by 2026 end. Developers and providers of quality management solutions are likely to invest more in development of pharmaceutical-specific software to capitalize on this opportunity.

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Driving Down Drug Costs: How Real-Time Transparency in PBMs Can Make a Difference

Article | July 19, 2022

In the ever-evolving healthcare landscape, transparency in pharmacy benefit management (PBM) has emerged as a critical issue. The discussion surrounding driving down prescription drug costs and increasing access to affordable medications has brought attention to the practices of PBMs. However, achieving true transparency requires more than just buzzwords; it necessitates access to real-time data that empowers consumers to make informed decisions about their healthcare. In this piece, we will explore the importance of real-time transparency in PBMs and highlight how Xevant, a leading platform, is revolutionizing the industry. The Current State of PBM Legislation With over 100 bills to reform PBM practices, legislative efforts are intensifying to address the business practices associated with PBMs. However, one common concern is the absence of language surrounding real-time automation in many of these bills. The lack of such provisions threatens to undermine the effectiveness of the proposed reforms. It is crucial to examine the available resources and insights to gain a comprehensive understanding of the issue. The current state of PBM legislation and the efforts to reform PBM practices highlight the pressing need for transparency and accountability in the pharmaceutical industry. PBMs play a critical role in the drug pricing ecosystem. Still, concerns about “traditional” PBM business practices, such as lack of transparency and opaque rebate systems, have raised questions about their impact on drug prices and patient access to affordable medications. Xevant's Groundbreaking Solution Xevant, led by CEO Brandon Newman, stands at the forefront of the drive for transparency in PBM practices. As the only platform capable of providing PBMs and consumers with real-time, automated, and completely transparent data from the entire pharmacy benefits ecosystem, Xevant is poised to revolutionize the industry against the backdrop of the political landscape. The absence of language surrounding transparency and real-time automation in many proposed bills threatens the effectiveness of the reforms. Yet, innovative companies like Xevant are leading the charge for openness in PBM practices. Xevant's real-time data automation and optimization capabilities empower consumers with timely, comprehensive, and transparent information, enabling them to make informed decisions about their healthcare and potentially save money. With the potential passage of these bills, the pharmaceutical industry could see a shift towards greater accountability, fairer pricing practices, and improved access to affordable medications. The reforms could also create a more level playing field for generic drug manufacturers, fostering competition and lowering prices. Real-Time Data Automation and Optimization Newman emphasizes that transparency cannot be achieved without access to real-time data automation and optimization. This real-time, customized data enables individuals to compare prices, explore alternatives, and understand the specific cost components related to their medications. By bringing together various parts of lowering drug costs, such as drug rebates, 340B contracts, sell-side discounts, copay assistance, and employer negotiations, Xevant offers a solution that empowers consumers with the information they need when required. The Implications of Timely Access to Data The scarcity of timely access to data among many traditional PBMs is a significant challenge in achieving transparency in the pharmaceutical industry. These PBMs typically collect data annually, which leaves a substantial margin of error and can result in millions of dollars lost from consumers' pockets. In contrast, Xevant's capabilities offer a game-changing solution. With Xevant's platform, consumers gain immediate access to critical information regarding drug rebates, markups during spread pricing, competitive alternatives, and the vast landscape of the pharmaceutical ecosystem. Having these complete datasets available in real-time allows individuals to make informed decisions about their healthcare and potentially save lives. The significance of timely access to data cannot be overstated, as transparency becomes meaningful only when it happens in the present rather than months, or even a year, later than when the impact has already occurred. Navigating Proposed Legislation and Questionable Business Practices Another critical aspect of the PBM landscape that Xevant addresses is the moral implications associated with cost-sharing, clawbacks, spread pricing, and the pass-through of rebates. These practices have long been criticized for their opacity and their negative consequences on patients' access to affordable medications. Xevant's transparency-focused approach highlights these practices, allowing stakeholders to evaluate their ethical implications and work towards fairer alternatives. Xevant recognizes that proposed legislation may have potential cracks that allow for slip-through and the continuation of questionable business practices. Delayed and inaccurate reporting are loopholes that can hinder the effectiveness of reform efforts. By actively engaging with legislators and industry stakeholders, Xevant aims to identify these potential shortcomings and advocate for comprehensive robust legislation that leaves no room forexploitation. The Future of Healthcare and the Role of Real-Time Automation As the discussion surrounding PBM reform gains momentum, the future of healthcare in America hangs in the balance. Xevant sets a new standard for efficiency and consumer empowerment in healthcare decision-making by employing AI-driven technology. Xevant's visionary approach to real-time data automation and optimization paves the way for greater transparency and cost savings in the pharmaceutical industry. Wrapping Up Transparency in pharmacy benefit management is crucial to addressing the soaring costs of prescription drugs and enhancing access to affordable medications. Without access to real-time data and automation, the pursuit of transparency remains elusive. Xevant's groundbreaking platform solves this pressing challenge, enabling PBMs and consumers to access complete, transparent data in real-time. As legislative efforts progress, the need for real-time transparency becomes increasingly evident, and Xevant emerges as the leading legal solution for PBMs. When harnessing the power of real-time data automation, the vision of affordable healthcare can be transformed into a reality, benefiting individuals and the entire healthcare ecosystem.

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Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | July 12, 2022

Painkillers like Oxycontin, Percocet, and Vicodin, have been prescribed by primary physicians, surgeons, dentists, and other healthcare providers to patients suffering from varying levels of pain. Though these medications have proven to be an effective source of pain relief, they have also proven to be highly addictive. In fact, it has even been reported that there are more cases of a drug overdose and deaths from prescription painkillers than heroin or cocaine. While there are a number of factors that play into this opioid epidemic, educating doctors and patients on alternative solutions to managing chronic pain is a great place to start combatting this nationwide crisis.

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What are the advantages of PCD Pharma Company?

Article | July 20, 2022

PCD Pharma stands for propaganda distribution. A PCD company gives brand name and support to its franchises. They also provide distribution rights and monopoly rights within a particular region. If a person wants to establish their business, it is a must for them to know the pros and cons of the business to make a sound decision. Needless to mention that PCD company has a lot to contribute in the medical filed. Worldwide in a medical field, A PCD Pharma Company is playing an essential and crucial role in the rapid growth. The pharma industry is progressing t a fast pace. The company uses the latest technologies for each brand which ensures the safety of products and accepts the responsibility of human health & life by providing better outcomes. To have a drug license number and company registration, the cost to establish the company is quite cost-effective that is15000-20000rs. So this gives people a brilliant opportunity to have their unit without digging a big hole in their bank balance. Indian produces exquisite quality products, which make pharma companies a considerable success.

Read More

WALGREEN’S IN HOT WATER OVER PHONY PHARMACIST

Article | February 11, 2020

The drugstore chain agreed to pay $7.5 million in fines after an unlicensed pharmacist at several San Francisco Bay locations illegally filled more than 700,000 prescriptions over a ten-year period. According to California prosecutors, Kim Thien Le stole license numbers from other pharmacists to fill prescriptions for Fentanyl, morphine, and other painkillers. Le pleaded guilty to multiple felony impersonation counts. Walgreen’s agreed to the settlement to avoid being charged with consumer fraud in Alameda and Santa Anna Counties. Prosecutors alleged that Walgreen’s failed to verify Le’s license and did not conduct a thorough background check. The company insisted it has taken remedial measures.

Read More
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Biosensors: An Emerging Technology in Pharmaceuticals

Article | July 19, 2022

In the ever-evolving healthcare landscape, transparency in pharmacy benefit management (PBM) has emerged as a critical issue. The discussion surrounding driving down prescription drug costs and increasing access to affordable medications has brought attention to the practices of PBMs. However, achieving true transparency requires more than just buzzwords; it necessitates access to real-time data that empowers consumers to make informed decisions about their healthcare. In this piece, we will explore the importance of real-time transparency in PBMs and highlight how Xevant, a leading platform, is revolutionizing the industry. The Current State of PBM Legislation With over 100 bills to reform PBM practices, legislative efforts are intensifying to address the business practices associated with PBMs. However, one common concern is the absence of language surrounding real-time automation in many of these bills. The lack of such provisions threatens to undermine the effectiveness of the proposed reforms. It is crucial to examine the available resources and insights to gain a comprehensive understanding of the issue. The current state of PBM legislation and the efforts to reform PBM practices highlight the pressing need for transparency and accountability in the pharmaceutical industry. PBMs play a critical role in the drug pricing ecosystem. Still, concerns about “traditional” PBM business practices, such as lack of transparency and opaque rebate systems, have raised questions about their impact on drug prices and patient access to affordable medications. Xevant's Groundbreaking Solution Xevant, led by CEO Brandon Newman, stands at the forefront of the drive for transparency in PBM practices. As the only platform capable of providing PBMs and consumers with real-time, automated, and completely transparent data from the entire pharmacy benefits ecosystem, Xevant is poised to revolutionize the industry against the backdrop of the political landscape. The absence of language surrounding transparency and real-time automation in many proposed bills threatens the effectiveness of the reforms. Yet, innovative companies like Xevant are leading the charge for openness in PBM practices. Xevant's real-time data automation and optimization capabilities empower consumers with timely, comprehensive, and transparent information, enabling them to make informed decisions about their healthcare and potentially save money. With the potential passage of these bills, the pharmaceutical industry could see a shift towards greater accountability, fairer pricing practices, and improved access to affordable medications. The reforms could also create a more level playing field for generic drug manufacturers, fostering competition and lowering prices. Real-Time Data Automation and Optimization Newman emphasizes that transparency cannot be achieved without access to real-time data automation and optimization. This real-time, customized data enables individuals to compare prices, explore alternatives, and understand the specific cost components related to their medications. By bringing together various parts of lowering drug costs, such as drug rebates, 340B contracts, sell-side discounts, copay assistance, and employer negotiations, Xevant offers a solution that empowers consumers with the information they need when required. The Implications of Timely Access to Data The scarcity of timely access to data among many traditional PBMs is a significant challenge in achieving transparency in the pharmaceutical industry. These PBMs typically collect data annually, which leaves a substantial margin of error and can result in millions of dollars lost from consumers' pockets. In contrast, Xevant's capabilities offer a game-changing solution. With Xevant's platform, consumers gain immediate access to critical information regarding drug rebates, markups during spread pricing, competitive alternatives, and the vast landscape of the pharmaceutical ecosystem. Having these complete datasets available in real-time allows individuals to make informed decisions about their healthcare and potentially save lives. The significance of timely access to data cannot be overstated, as transparency becomes meaningful only when it happens in the present rather than months, or even a year, later than when the impact has already occurred. Navigating Proposed Legislation and Questionable Business Practices Another critical aspect of the PBM landscape that Xevant addresses is the moral implications associated with cost-sharing, clawbacks, spread pricing, and the pass-through of rebates. These practices have long been criticized for their opacity and their negative consequences on patients' access to affordable medications. Xevant's transparency-focused approach highlights these practices, allowing stakeholders to evaluate their ethical implications and work towards fairer alternatives. Xevant recognizes that proposed legislation may have potential cracks that allow for slip-through and the continuation of questionable business practices. Delayed and inaccurate reporting are loopholes that can hinder the effectiveness of reform efforts. By actively engaging with legislators and industry stakeholders, Xevant aims to identify these potential shortcomings and advocate for comprehensive robust legislation that leaves no room forexploitation. The Future of Healthcare and the Role of Real-Time Automation As the discussion surrounding PBM reform gains momentum, the future of healthcare in America hangs in the balance. Xevant sets a new standard for efficiency and consumer empowerment in healthcare decision-making by employing AI-driven technology. Xevant's visionary approach to real-time data automation and optimization paves the way for greater transparency and cost savings in the pharmaceutical industry. Wrapping Up Transparency in pharmacy benefit management is crucial to addressing the soaring costs of prescription drugs and enhancing access to affordable medications. Without access to real-time data and automation, the pursuit of transparency remains elusive. Xevant's groundbreaking platform solves this pressing challenge, enabling PBMs and consumers to access complete, transparent data in real-time. As legislative efforts progress, the need for real-time transparency becomes increasingly evident, and Xevant emerges as the leading legal solution for PBMs. When harnessing the power of real-time data automation, the vision of affordable healthcare can be transformed into a reality, benefiting individuals and the entire healthcare ecosystem.

Read More
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Use of AI: Reshaping the Pharmaceutical Industry

Article | July 12, 2022

Painkillers like Oxycontin, Percocet, and Vicodin, have been prescribed by primary physicians, surgeons, dentists, and other healthcare providers to patients suffering from varying levels of pain. Though these medications have proven to be an effective source of pain relief, they have also proven to be highly addictive. In fact, it has even been reported that there are more cases of a drug overdose and deaths from prescription painkillers than heroin or cocaine. While there are a number of factors that play into this opioid epidemic, educating doctors and patients on alternative solutions to managing chronic pain is a great place to start combatting this nationwide crisis.

Read More
Pharma Tech

Precision Medicine: New Horizons in Pharmaceuticals

Article | July 20, 2022

PCD Pharma stands for propaganda distribution. A PCD company gives brand name and support to its franchises. They also provide distribution rights and monopoly rights within a particular region. If a person wants to establish their business, it is a must for them to know the pros and cons of the business to make a sound decision. Needless to mention that PCD company has a lot to contribute in the medical filed. Worldwide in a medical field, A PCD Pharma Company is playing an essential and crucial role in the rapid growth. The pharma industry is progressing t a fast pace. The company uses the latest technologies for each brand which ensures the safety of products and accepts the responsibility of human health & life by providing better outcomes. To have a drug license number and company registration, the cost to establish the company is quite cost-effective that is15000-20000rs. So this gives people a brilliant opportunity to have their unit without digging a big hole in their bank balance. Indian produces exquisite quality products, which make pharma companies a considerable success.

Read More

WALGREEN’S IN HOT WATER OVER PHONY PHARMACIST

Article | February 11, 2020

The drugstore chain agreed to pay $7.5 million in fines after an unlicensed pharmacist at several San Francisco Bay locations illegally filled more than 700,000 prescriptions over a ten-year period. According to California prosecutors, Kim Thien Le stole license numbers from other pharmacists to fill prescriptions for Fentanyl, morphine, and other painkillers. Le pleaded guilty to multiple felony impersonation counts. Walgreen’s agreed to the settlement to avoid being charged with consumer fraud in Alameda and Santa Anna Counties. Prosecutors alleged that Walgreen’s failed to verify Le’s license and did not conduct a thorough background check. The company insisted it has taken remedial measures.

Read More
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Aquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film in Pediatric Patients

globenewswire | September 12, 2023

Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024. Aquestive’s NDA for approval of Libervant™ Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age has been accepted by the FDA. Diastat® (diazepam) Rectal Gel is the only treatment currently available to this patient population for this indication. The Company received tentative approval for Libervant for the treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients 12 years of age and older in August 2022, but Libervant is currently under an orphan drug block to market access until January 2027. “The FDA’s acceptance of our most recent filing for Libervant is another step forward in bringing this important treatment option to patients,” said Daniel Barber, Chief Executive Officer of Aquestive. “When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options. We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access.” About Libervant Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA has granted tentative approval for Libervant for treatment of these epilepsy patients 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. The NDA submitted today for Libervant for epilepsy patients between two and five years of age is subject to FDA approval, including for U.S. market access. About Aquestive Aquestive is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.

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Biofourmis Accelerates and Simplifies Drug Development with Expanded Digital Clinical Trials Solution

prnewswire | September 21, 2023

Biofourmis, a leading global technology-enabled care delivery company, announced today the release of its expanded Digital Clinical Trials solution within the Biofourmis platform for biopharma and other life sciences companies. The solution offers robust digital tools and resources for trial sponsors and investigators aimed at accelerating drug development and improving access and diversity while also reducing costs. Biofourmis' Digital Clinical Trials solution includes a technology-enabled, scalable platform and services that support digital tools enablement, trial decentralization, safety monitoring, personalized care, easier participant recruitment and more equitable access to treatment options for patients everywhere. The solution helps sponsors and researchers accelerate clinical development with remote data collection and novel digital endpoints from Biofourmis' library of biomarkers across multiple therapeutic areas. 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prnewswire | September 01, 2023

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Aquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film in Pediatric Patients

globenewswire | September 12, 2023

Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024. Aquestive’s NDA for approval of Libervant™ Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age has been accepted by the FDA. Diastat® (diazepam) Rectal Gel is the only treatment currently available to this patient population for this indication. The Company received tentative approval for Libervant for the treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients 12 years of age and older in August 2022, but Libervant is currently under an orphan drug block to market access until January 2027. “The FDA’s acceptance of our most recent filing for Libervant is another step forward in bringing this important treatment option to patients,” said Daniel Barber, Chief Executive Officer of Aquestive. “When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options. We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access.” About Libervant Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA has granted tentative approval for Libervant for treatment of these epilepsy patients 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. The NDA submitted today for Libervant for epilepsy patients between two and five years of age is subject to FDA approval, including for U.S. market access. About Aquestive Aquestive is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.

Read More

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Biofourmis Accelerates and Simplifies Drug Development with Expanded Digital Clinical Trials Solution

prnewswire | September 21, 2023

Biofourmis, a leading global technology-enabled care delivery company, announced today the release of its expanded Digital Clinical Trials solution within the Biofourmis platform for biopharma and other life sciences companies. The solution offers robust digital tools and resources for trial sponsors and investigators aimed at accelerating drug development and improving access and diversity while also reducing costs. Biofourmis' Digital Clinical Trials solution includes a technology-enabled, scalable platform and services that support digital tools enablement, trial decentralization, safety monitoring, personalized care, easier participant recruitment and more equitable access to treatment options for patients everywhere. The solution helps sponsors and researchers accelerate clinical development with remote data collection and novel digital endpoints from Biofourmis' library of biomarkers across multiple therapeutic areas. The expanded solution offers a more holistic workflow, new data management automations and a seamless integration of essential clinical trial documentation, participant scheduling and data collection elements. Because the artificial intelligence (AI)-powered platform is highly configurable, study start-up timelines can be reduced from months to days. The connected platform seamlessly integrates with 40+ devices, enabling study teams the freedom to select the right device for the right disease area. Biopharma companies can also tap into Biofourmis' growing principal investigator (PI) network. The network includes experienced and esteemed PIs from leading academic medical centers as a valuable resource to manage digitally driven research and accelerate the pace of recruitment with access to patient databases. Health systems that already use the Biofourmis platform for technology-enabled care delivery at home can easily and quickly expand their clinical research initiatives by leveraging the connected platform to include the Digital Clinical Trials functionality. "We have consistently earned high satisfaction scores from both researchers and trial participants for our solutions. Now, we have identified additional ways to accelerate access to digital clinical trials, lower costs, and improve the experience for all stakeholders," said Biofourmis COO Jaydev Thakkar. "These new technology and service elements create a more holistic, turnkey solution that achieves those aims while offering greater synergies from drug development to commercialization and creating equitable access to treatment options and clinical research for patients everywhere." Market-leading enhancements to the Digital Clinical Trials solution include Robust eConsent and ePROs Capabilities: Robust screening and informed consent tools are integrated into workflows to accelerate recruitment, decrease enrollment time, and help ensure that participants fully understand risks and benefits associated with the trial. The documentation content is easily configurable and compliant with regulatory requirements. The enhanced ePROs (electronic patient-reported outcomes) collection capabilities drive adherence through automated reminders of participants' reporting requirements while offering them the ability to easily share outcomes beyond traditional clinical measures. Reporting flexibility offers investigators increased visibility into participant safety, health and experience. Dynamic Participant Scheduling: Upon enrollment, the Digital Clinical Trials solution helps research stay on course while encouraging participant adherence and engagement through a virtual visit and schedule of assessment module that streamlines all the "to-do" items for the participant and caregiver, intuitively listing all the required patient reporting and external assessment tasks. Reminders and notifications help participants stay adherent; but if a task is missed, the schedule can automatically adjust so the participant can remain enrolled, and the trial can move forward. InHome Services: As with all solutions within Biofourmis Connect and Care, In-Home Services such as nurse visits, phlebotomy, infusion, imaging, and other ancillary services delivered within the home are available via the connected platform to support decentralized clinical trials—which further reduces burden on investigators and participants. Unmatched Safety Monitoring: The solution leverages AI to monitor the efficacy and side effects of drugs. A specific example includes pre-screening for clinical events triggered by high potassium levels (hyperkalemia), which can reduce clinical trial costs by decreasing frequent manual checks by medical professionals while still protecting patient safety. In addition, cardiac safety monitoring capabilities such as auto-detection of QTc prolongation (an extended interval between the heart contracting and relaxing) can improve the safety of trials by detecting patients earlier who are at risk of developing critical heart arrhythmias due to drug side effects. "Leveraging digital tools and automating and accelerating trial processes for both researchers and participants can increase the likelihood that endpoints will be reached sooner, which lowers costs and simplifies tasks for everyone involved," Thakkar said. "More importantly, shorter trials with more meaningful results mean that groundbreaking new therapies can be discovered and developed faster to improve outcomes for patients worldwide." About Biofourmis Biofourmis brings the right care to every person, no matter where they are. The company's AI-driven solution collects and analyzes patient data in real time and identifies shifts that require proactive interventions. This vital innovation provides people everywhere with connected access to hospital-level services, virtual provider networks for remote care, in-home services, and life-changing clinical trials—all without leaving their homes. Trusted by leading health systems, payers, biopharma companies and patients alike, Biofourmis' connected platform improves patient outcomes, prevents hospital readmissions, accelerates drug development, and closes critical gaps in care—ultimately making science smarter, healthcare simpler, and patients healthier.

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Pharmacy Market

Evolution Health Announces Revolutionary Technology Platform to Transform Stakeholder Engagement and Actively Measure Their Impact for Pharmaceutical

prnewswire | September 01, 2023

Evolution Health Group (EHG), a leading name in medical communications, pharmaceutical strategic marketing, and digital solutions, unveiled its game-changing technology platform, 360Connex®, set to redefine the landscape of stakeholder engagement. The primary objective of this robust platform is to enable enterprises to scale and target their engagement initiatives effectively. With a focus on efficiency, transparency, and actionable insights, organizations can now make data-driven decisions and foster stronger relationships with their stakeholder communities. This state-of-the-art platform is geared towards three core functionalities Management, Monitoring, and Measurement of Stakeholder Engagement: Through an intuitive interface and innovative technologies, enterprises can now efficiently manage, track, and measure the impact of their interactions with their key stakeholders, streamlining the collaboration process and helping teams focus their resources and strategies to ensure maximum impact on the business. Facilitation of Speaker Programs: The platform offers tools that will not only simplify the coordination and execution of speaker programs, but also ensure they meet the highest standards of content delivery and engagement. Application of Advanced Analytics: By harnessing the power of artificial intelligence, machine learning, and advanced automation technologies, EHG's 360Connex® platform offers unprecedented insights and optimization opportunities. This ensures that engagement activities are not only scaled, but also aligned with the dynamic needs of the stakeholder community. The platform is designed to meet the differing needs of emerging organizations through the largest of enterprises. "The healthcare community is rapidly evolving, and traditional methods of engagement are no longer sufficient. Our new technology platform bridges the gap, empowering enterprises to create more impactful, meaningful, and measurable interactions with their key stakeholders in a cost-effective way that ensures ongoing transparency and accountability," commented Carolyn Vogelesang Harts, one of the Managing Partners of Evolution Health Group. The unveiling of 360Connex® comes at a pivotal moment in the healthcare industry. As interactions between enterprises and healthcare professionals become increasingly intricate, there is a pressing need for systems that simplify processes and provide actionable insights. EHG's 360Connex® platform is the answer to this pressing demand. This innovation is poised to usher in a new era of insight-driven engagement, ensuring that healthcare companies not only keep pace with, but also anticipate the needs of, their diverse professional audiences. About Evolution Health Group Founded in 2005 and based in Pearl River, NY, Evolution Health Group stands at the forefront of pharmaceutical strategy, marketing, and digital solutions for global healthcare companies. EHG provides distinctive services through three main divisions; Evolution Medical Communications for medical and scientific strategy, blulava, for technology and digital solutions, and Maestro360 for speaker program logistic management.

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