MCRA’s Post

As CMS begins to negotiate Medicare drug prices under the Inflation Reduction Act, it should use data about what patients value when defining a drug’s “clinical benefit.” CMS should also create an ongoing process to include voices of patients and providers in valuing drugs. In this special edition of the Journal of Managed Care & Specialty Pharmacy, researchers provide a patient engagement framework that includes establishing a robust infrastructure dedicated to educating the patient community; hiring patient navigators to provide information to patients about the impact of policies and to receive feedback from patients; and developing a system of data collection and evaluation https://bit.ly/3TCzYVw #managedcare #pharmacy #IRA #Medicare

This Clinical Trials Arena article offers a comprehensive overview of #DCTs and whether sponsors are getting better at conducting them >>  https://lnkd.in/epMjahVF   It reminded us of a recent public meeting held by the Reagan-Udall Foundation for the FDA, “Good Clinical Practice: Considerations for Trials with Pragmatic or Decentralized Features.”   We summarized the meeting and thought our blog might help, if people are interested in the best practices discussed during the public meeting.    One takeaway? Challenges with decentralized trials can also be common to “traditional” trials. It’s all in the design and preparation.   You can find a link to the first blog here. https://lnkd.in/eUqYvjAA #clinicalresearch #clinicaltrials #GCP #FDA

#ICYMI: The Biosimilars Forum was featured in a Bloomberg Law article on employer concerns of higher costs after Medicare drug negotiations. Hear from the Forum in the article below on why lower-costs biosimilars must be prioritized to bring affordability and access to U.S. healthcare. #biosimilars #medicare #costsavings https://lnkd.in/ewSQCEWJ

Having partnered with some of the world’s most successful healthcare innovators, MCRA’s clinical team has real-world experience in developing effective clinical trial strategies. We work diligently to understand a study’s goals and specifications, review all applicable documents and develop a detailed plan to begin each study.   Ensuring you have the right study design and are targeting the appropriate patients and strongest sites will put you on the path to success as you begin your trial.  #MCRA #CRO #ClinicalResearch #MedicalTechnology #MedicalDevice #ClinicalResearch #Regulatory #Reimbursement #compliance #SpecializedTherapyExpertise Learn how to optimize your trials with advice from global clinical research experts! Contact Us https://lnkd.in/ehwSCmAm

Intrinseque Health is an EN ISO 13485 certified, global drug development support organisation. In the world of clinical trials, precision, reliability, and compliance are paramount. As an EN ISO 13485 certified company, we specialize in overcoming the most complex clinical supply challenges. Our meticulously designed distribution and logistics network is meticulously crafted to guarantee timely and seamless supply delivery to clinical trial sites. With it’s extensive global network of strategically located warehouses, Intrinseque Health ensures clinical trial supplies are readily available precisely where and when they are needed Intrinseque Health takes it a step further by offering Direct-to-Patient services, providing a patient-centric approach while unwaveringly adhering to both local and international regulations. Our commitment: 'We Build and Execute Complex Clinical Supply Plans.' Because we understand that every detail counts, and success in clinical trials depends on it. Choose Intrinseque Health for best-in-class clinical supply chain services. Contact us today to discuss how Intrinseque Health can create a robust clinical supply plan for your clinical development programs. contact@intrinsequehealth.com https://lnkd.in/gPWaDs_n #drugdiscovery #drugdevelopment #studystartup #clinicaltrials #healthcare #clinicalresearch #patientrecruitment #sitemanagement #clinicaldevelopment #clinicaltrial #clinicaloperations #clinicalstudy #clinicalsupply

Intrinseque Health is an EN ISO 13485 certified, global drug development support organisation. In the world of clinical trials, precision, reliability, and compliance are paramount. As an EN ISO 13485 certified company, we specialize in overcoming the most complex clinical supply challenges. Our meticulously designed distribution and logistics network is meticulously crafted to guarantee timely and seamless supply delivery to clinical trial sites. With it’s extensive global network of strategically located warehouses, Intrinseque Health ensures clinical trial supplies are readily available precisely where and when they are needed Intrinseque Health takes it a step further by offering Direct-to-Patient services, providing a patient-centric approach while unwaveringly adhering to both local and international regulations. Our commitment: 'We Build and Execute Complex Clinical Supply Plans.' Because we understand that every detail counts, and success in clinical trials depends on it. Choose Intrinseque Health for best-in-class clinical supply chain services. Contact us today to discuss how Intrinseque Health can create a robust clinical supply plan for your clinical development programs. contact@intrinsequehealth.com https://lnkd.in/gPWaDs_n #drugdiscovery #drugdevelopment #studystartup #clinicaltrials #healthcare #clinicalresearch #patientrecruitment #sitemanagement #clinicaldevelopment #clinicaltrial #clinicaloperations #clinicalstudy #clinicalsupply

Intrinseque Health is an EN ISO 13485 certified, global drug development support organisation. In the world of clinical trials, precision, reliability, and compliance are paramount. As an EN ISO 13485 certified company, we specialize in overcoming the most complex clinical supply challenges. Our meticulously designed distribution and logistics network is meticulously crafted to guarantee timely and seamless supply delivery to clinical trial sites. With it’s extensive global network of strategically located warehouses, Intrinseque Health ensures clinical trial supplies are readily available precisely where and when they are needed Intrinseque Health takes it a step further by offering Direct-to-Patient services, providing a patient-centric approach while unwaveringly adhering to both local and international regulations. Our commitment: 'We Build and Execute Complex Clinical Supply Plans.' Because we understand that every detail counts, and success in clinical trials depends on it. Choose Intrinseque Health for best-in-class clinical supply chain services. Contact us today to discuss how Intrinseque Health can create a robust clinical supply plan for your clinical development programs. contact@intrinsequehealth.com https://lnkd.in/gPWaDs_n #drugdiscovery #drugdevelopment #studystartup #clinicaltrials #healthcare #clinicalresearch #patientrecruitment #sitemanagement #clinicaldevelopment #clinicaltrial #clinicaloperations #clinicalstudy #clinicalsupply

Intrinseque Health is an EN ISO 13485 certified, global drug development support organisation. In the world of clinical trials, precision, reliability, and compliance are paramount. As an EN ISO 13485 certified company, we specialize in overcoming the most complex clinical supply challenges. Our meticulously designed distribution and logistics network is meticulously crafted to guarantee timely and seamless supply delivery to clinical trial sites. With it’s extensive global network of strategically located warehouses, Intrinseque Health ensures clinical trial supplies are readily available precisely where and when they are needed Intrinseque Health takes it a step further by offering Direct-to-Patient services, providing a patient-centric approach while unwaveringly adhering to both local and international regulations. Our commitment: 'We Build and Execute Complex Clinical Supply Plans.' Because we understand that every detail counts, and success in clinical trials depends on it. Choose Intrinseque Health for best-in-class clinical supply chain services. Contact us today to discuss how Intrinseque Health can create a robust clinical supply plan for your clinical development programs. contact@intrinsequehealth.com https://lnkd.in/gPWaDs_n #drugdiscovery #drugdevelopment #studystartup #clinicaltrials #healthcare #clinicalresearch #patientrecruitment #sitemanagement #clinicaldevelopment #clinicaltrial #clinicaloperations #clinicalstudy #clinicalsupply

Provider-Payer Contract Disputes are Intensifying Due to Rising Costs Economic challenges post-COVID-19 are fueling contention, with providers facing increased labor, supply, and pharmaceutical costs. Providers are frustrated by payer denials and low reimbursement rates, sometimes canceling contracts. Payers also face higher costs as patients seek deferred care. Both sides struggle with inflation, impacting negotiations. Providers demand fair rates, citing increased administrative burdens and claim denials. Payers argue that some providers, particularly large ones, demand excessive rates and improved performance. Recent disputes highlight the growing tension, with providers sometimes opting out of unfavorable contracts. Before canceling contracts which often makes matters worse, consider a comprehensive analysis and strategy to improve contracts. Both parties can win with comprehensive strategies that address the needs of both payers and providers.

Introducing Clinical Confidential, a new document series from MCRA’s Global Clinical Research Organization. In this series, we’ll reveal the interrelated requirements of clients developing novel healthcare technologies from a global perspective. Led by a team of industry experts and informed by the entire commercialization process, the series will help guide established companies and startups through the clinical trial labyrinth with the goal of maximizing the value of their healthcare innovations.  #MCRA #CRO #ClinicalResearch #MedicalTechnology #MedicalDevice #ClinicalResearch, #Regulatory, #Reimbursement, #compliance #SpecializedTherapyExpertise Learn how to optimize your trials with advice from global clinical research experts! Contact Us  https://lnkd.in/ehwSCmAm