MCRA’s Post

Join James Mullally, Dan Goldstein, and Julie Martel, PhD, MCRA’s expert IVD Team on Tuesday July 16th at 10am EST for our webinar, LDT vs. IVD: Adapting to the New FDA Regulations. Learn about the FDA’s final rule on the regulation of Laboratory Developed Tests (LDTs), the timeline for enforcement, key aspects of the rule, and how your organization can align with the new FDA requirements. Register now: https://lnkd.in/e8vFVenq #IVD #LDT #LDTruling #FDA #FDAregulation #FDAregulatory #FDAcompliance #qualityassurance #LDTvsIVD #webinar #laboratorydevelopedtests #FDArule #IVDregulation #MCRA

Healthcare innovators typically design their trials with safety and effectiveness, regulatory approval and robust data in mind. However, they often neglect the necessity of a sound reimbursement strategy. MCRA’s Life Sciences Advisory Panel (LSEAP) offers valuable stakeholder feedback to accelerate market adoption. We also provide a detailed foundational assessment of current payer coverage, as well as coding and payment policies to help you identify the most strategic reimbursement pathway for successful commercialization of your innovation  #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

One week away! Don’t miss MCRA’s IVD Experts James Mullally, Dan Goldstein, and Julie Martel, PhD for our webinar LDT vs. IVD: Adapting to the New FDA Regulations. Join us on Tuesday July 16th at 10am EST, as they discuss the FDA’s final rule on the regulation of Laboratory Developed Tests (LDTs), the timeline for enforcement, key aspects of the rule, and how your organization can align with the new FDA requirements and more. Register here: https://lnkd.in/e8vFVenq #IVD #LDT #LDTruling #FDA #FDAregulation #FDAregulatory #FDAcompliance #qualityassurance #LDTvsIVD #webinar #laboratorydevelopedtests #FDArule #IVDregulation #MCRA

Meet MCRA: Nicholas Giokas, Director of Spine Clinical Affairs & Safety Lead   Nick Giokas oversees both the Spine CRO division & Safety Committees at MCRA. He has been with the firm since 2018.  Nick has led studies in both cervical and lumbar indications, both in motion sparring and fusion devices. As the Safety Lead at MCRA, Nick was the chief strategist in the design of the MCRA procedures for safety committee management and leads recruiting efforts for safety committee physicians. He has also designed and managed multiple Clinical Events Committees, Data Safety Monitoring Boards, and Protocol Advisory Committees across several different indications (Spine, Neurology, Orthopedics, Wound Care).    Prior to joining MCRA, worked on the clinical operations team with a mid-sized sponsor. The pipeline he worked on included multiple global phase III pharmaceutical IND studies. The studies included both adult and pediatric patient populations and spanned across the US, Canada, and EU.   Learn more about Nick Giokas now: https://lnkd.in/eJFTWJz4

MCRA wishes you a safe and Happy 4th of July!

Recruiting and training clinical trial staff is a costly and time-consuming process. MCRA has a ready pool of sites and experts, saving you the expenses associated with recruitment and onboarding. MCRA’s contracting team has worked with hundreds of sites and institutions across the globe. We leverage our extensive experience and relationships to streamline the process of implementing  clinical trials for our clients  — saving them significant time and money. #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

The diverse nature of wounds makes their treatments complex and ever-changing. Count on MCRA’s expert dermatology and wound care consultants to help ensure an effective product life cycle from concept to market. Learn more about the services we offer for wound care, dermatology and biologics at out website: https://lnkd.in/euhAYCMr #woundcare #woundhealing #woundmanagement #woundcareinnovation #woundcaredevice

MCRA’s experts can help your company navigate the complexities of Quality Assurance with ease. From product review, approval, and regulatory compliance, our expertise and insider FDA and Notified Bodies experience can help bring your device to market faster while maintaining QA requirements and ensuring uninterrupted market presence.   Learn more about our Quality Assurance services here: https://lnkd.in/e-YgijJd #QualityAssurance #QA #MedTech #medicaldevices #medicalequipment #MCRA #MedtechQA #biotech 

Interested in learning more about the FDA’s new regulation for Laboratory Developed Tests (LDTs)? Join MCRA’s IVD experts on Tuesday July 16th at 10am EST for LDT vs. IVD: Adapting to the New FDA Regulations.    This webinar will delve into the timeline for enforcement, the key aspects of the ruling, and how your organization can align with the new FDA requirements.   https://lnkd.in/e8vFVenq James Mullally, Dan Goldstein, Julie Martel, PhD   #IVD #LDT #LDTruling #FDA #FDAregulation #FDAregulatory #FDAcompliance #qualityassurance #LDTvsIVD #webinar #laboratorydevelopedtests #FDArule #IVDregulation #MCRA #FDAconsultants #biotech #biotechindustry #medtechindustry #medicaldevices