Bryan Clayton’s Post

#eCOA should not be on the critical path to FPI. Yet, despite industry’s best efforts, delivery timelines haven’t reduced. In fact, some might argue they have actually increased. It doesn’t need to be that way! In this Applied Clinical Trials Magazine article, Willie Muehlhausen 🇺🇦 and I explain why streamlining software build alone cannot resolve the problem. We share our thoughts on new ways to approach operational processes, including #licensing #translations #UAT and #ethics to create smoother, more efficient processes, accelerate eCOA delivery, and ensure timely delivery to meet FPI milestones. https://lnkd.in/ecUH-Pmp

Building studies and ePRO/eClinRO assessments is straightforward and quick, if you have the (Veeva!) tools. Tim & Willie dive into the steps which remain on the Project Manager's nemesis, the critical path.

What are the keys to successfully and timely selection and implementation of clinical outcome assessments in your clinical study? (#COAs, #PROMs, #ObsRo, #ClinRo, #eCOA, #ePROMs) At Mapi Research Trust, we have developed a complete suite of services to support your patient-centric endpoint strategy and implementation. - Databases: COA description (PROQOLID™), COA label claims (PROLABELS™) and regulatory recommendations on COAs (PROINSIGHT™) - Patient-centered endpoint intelligence: our team perfoms a targeted but comprehensive landscape analysis customized to answer you strategic question - Streamlined COA licensing process for any COAs, distributed by Mapi Research Trust or not (information search, conditions of use, availability of translations and eCOA and gap analysis, scoring guides, license agreements) - Coordination of translation projects (collaboration with ICON plc Language Services) - eCOA Services: eCOA licensing, eCOA best practice guidance, screenshot review and eCOA certification. - COA Repository: a unique repository for all COAs used in your clinical studies Learn more on each service, visit our website: https://lnkd.in/ejdngCks #COAlicensing #patientcentricity #clinicaltrials #clinicalstudies

The persisting reliance on eIDAS standards sparks questions. Does this stem from perceiving eConsent as an 'Open' system?    In evaluating your eConsent system, the crucial question arises: Is it treated as an 'Open' or 'Closed' system? At THREAD, we define our platform services provided as a 'Closed' system design, eliminating the complexities associated with additional eSignature controls.     Check out this article to learn more: https://bit.ly/49ENrCe      #eConsent #ClinicalTrials #ElectronicSignatures

How to minimize the risks associated with digitization of Clinical Outcome Assessments (COAs)?  Our #eCOA implementation experts answer this question in this new whitepaper: Digitizing COAs, a streamlined approach to approval. Indeed, COAs are scientific material that must be used as prescribed by the COA developer in order to ensure the validity of the data collected. For this reason, their implementation in electronic format must follow several validation steps and adhere to both generic guidance for all eCOAs and specific requirements related to the particular assessment. Read the whitepaper now: https://lnkd.in/e7FDMNYA #ePRO #DCT #decentralizedtrials #clinicaltrials #patientcentricity #COAs

Making Clinical Engineering in the Republic of Namibia a Reality

Our #DigitalHealth group has recently been focussing on digital diagnostics - the rapidly growing area of software-based methods for diagnosing and monitoring health conditions. Many patent offices, including the European Patent Office, prohibit the patenting of methods of diagnosis performed on the human body - but to what extent does this limit the protection of computer-implemented methods of diagnosis? In this article we examine the current legal position and provide recommendations for applicants in this area, to ensure they secure the strongest protection for their innovation. #healthtech #digitalhealth #patents

With the rapid growth of the digital diagnostics sector, driven by advancing technology and the demand for personalised healthcare, safeguarding these breakthroughs is more important than ever. Authors Jack Severs, Joe McCartney, and James Taylor shed light on the uncertainty surrounding the patentability of digital diagnostic methods, especially when combining hardware features with software implementation. https://lnkd.in/eDYm8V7m   #digitalhealth #intellectualproperty #patents

Clinical trial sponsors need a #LifeSciences #Translation services team and tools to help them achieve COA goals and maintain compliance in every dialect. Watch our video to see how our new Lionbridge Aurora Clinical Outcomes tool assists with #ClinicalTrial translations. #Lionbridge #BreakingBarriers #BuildingBridges

Day 3: Technological Integration and Efficiency Today, we continue our review of key findings on critical topics in clinical trials from various reputable sources. Let’s look at today's focus: Summary: The integration of advanced technologies, such as electronic data capture (EDC) and workflow-based systems, can enhance efficiency but also poses challenges. Organizations often struggle with entrenched silos and a lack of understanding of downstream needs, leading to inefficiencies and increased training burdens. Source: For a deeper understanding, see ISPE’s article on improving study start-up and the clinical trial continuum: https://lnkd.in/g4eHwhUb I invite you to review the article and discuss your insights and experiences with technological integration in clinical trials. #ClinicalResearch #TechnologyIntegration #EDC #ClinicalTrials