HiRO - Harvest Integrated Research Organization’s Post

🔍Uncover the secrets behind our Phase 3 dermatology trial success! Our latest case study shows how effective RBQM can protect data quality and ensure trial triumph. Get the inside scoop on real-world risk management and see how you can elevate your clinical trials. Check it out: https://hubs.ly/Q02FTx_B0 #ClinicalTrials #RBQM #DataQuality

Earlier this month, Clario was at #ISPOR2024 in Atlanta and presented two scientific posters. For those of you who missed them, below are a few takeaways.   Compliance and Design Features of Electronic Participant-Reported Dosing Diaries 1) More consistency is needed in the types of questions dosing diaries include and standardization of requirements to support data quality. 2) High compliance over time and across studies with dosing diaries supports the use of eDiaries as an indicator for drug adherence.   Electronic Collection of PRO Measures in Dermatology Trials 1) ePROs are common in dermatology trials and are targeted as primary and key secondary endpoints in successful FDA approvals. 2) Clario has successfully supported electronic collection of PROs in dermatology trials for primary and key secondary endpoints.   For any questions on how to optimize your dosing diary or dermatology trial using ePROs, please contact science@clario.com   #sciencematters #ePRO #ediaries

🌟 Successful USFDA Inspection at Our Dermatology Site. We are delighted to share that our recent USFDA inspection at one of our dermatology sites concluded with no 483/inspectional observations. However, we'd like to highlight two crucial recommendations from the inspection team that we believe if shared will benefit all stakeholders in clinical research industry. Recommendation 1: Ensure that completed CRFs come with the audit trail. The CRO initially did not provide the audit trail information along with the CRFs. Although the request was promptly addressed during the inspection, it is strongly recommended that CROs consistently provide audit trail information and sites should ensure that they recieved the same during close out or post close out. Recommendation 2: Utilize data loggers for recording IP temperature instead of manual recording from thermohygrometers. The inspector emphasized that relying solely on a hygrometer for temperature recording, which provides minimum and maximum values in a 24-hour period, might not capture multiple excursions. We have accepted this recommendation and assured the inspector that we will convey the same to the sponsor from the next study onwards. These recommendations are not just regulatory requirements but steps toward enhancing transparency, accuracy, and reliability in our clinical research processes. We value continuous improvement and are committed to implementing best practices. We would like to thank the inspection team for their valuable feedback and insights. #clinicalresearch #FDAInspection #DermatologyResearch 🌐🔬#clinicaloperations

With ReferralMD, Dermatology practices can: ✔️optimize their referral process for enhanced quality referrals ✔️streamline patient intake ✔️ensure seamless communication with referring providers ReferralMD's platform allows referral staff to efficiently manage referrals, schedule appointments, and facilitate effective communication with providers and patients, resulting in a more streamlined and effective process. Learn more at https://bit.ly/3IMqSPP #dermpractices #referralmanagement

Access is the PRIORITY! 🌟 In Episode Four, Angela Lee, PACS emphasizes the importance of documenting everything to ensure a derm patient's quality of life is impacted. Angie explains that making a difference in patients' lives is one of the most rewarding aspects of being a Biologic Coordinator, Operations Manager, and ACBC board member. And you can only make a difference when you have all the FACTS! Listen to Episode Four and learn how Angie improves dermatology offices one document at a time.

Pharmacists and pharmacy technicians are often the first point of contact for patients seeking guidance on OTC skin care products. As such, it's essential that they're equipped to provide accurate and up-to-date information on dermatological health and protection. Check out the resource center at Pharmacy Times Continuing Education™ (PTCE) on optimizing skin care and outcomes in skin conditions through OTC options. The webinars also cover the current American Academy of Dermatology guidelines for managing and treating these conditions. The 5 activities in this webinar curriculum demonstrate commitment to improving patient education and identifying potential triggers, as well as recommending therapies to effectively manage these conditions while restoring and maintaining the skin barrier function. Crystal Yu, PharmD CeraVe

Living with eczema can be unpredictable and challenging, especially for people with skin of color like Lillian. At #AAD2024, Eli Lilly and Company presented new and exciting data from a first-of-its-kind Lilly study designed for people with skin of color and moderate-to-severe atopic dermatitis. These findings are a testament to our commitment to improving healthcare equity in dermatology by building a better understanding between healthcare providers and patients. https://e.lilly/439PtYk

🧠 Discover our Complimentary CME Offering: 'Clinical Insights into Psoriasis in Patients of Color: Bringing New Data to Light' with 1.00 CME Credits! 🌟 Unlock essential knowledge about managing psoriasis in patients with skin of color. Gain insights from experts Mona Shahriari, MD, and Andrew F. Alexis, MD, MPH, as they delve into clinical updates, treatment nuances, and strategies for personalized care. Don't miss this opportunity to earn CME credits and enhance your dermatology practice! Click the link below to start this activity 👇 https://lnkd.in/gkwmwGBp

Gave a talk at Northeast Dermatology Conference on “A practical approach to using JAK inhibitors in dermatology”. Thanks for the great turnout! - via #Whova event app My 3-step approach to discussing the “boxed warning” : 1) NORMALIZE the boxed warning: we have a lot of medications in dermatology, including OTC, that also contain a boxed warning, but we continue to use these medications with regularity because we understand the context behind them. 2) CONTEXTUALIZE the boxed warning: different drugs, different diseases, different demographics WITHOUT a placebo group. This last point is crucial as we can interpret the ORAL surveillance study in 3 ways: A) Risk: JAKi > no treatment > TNFi B) Risk: JAKi = no treatment > TNFi C) Risk: no treatment > JAKi > TNFi *Time will tell but we also have to acknowledge that not treating/undertreating a disease has negative downstream effects as well. 3) REFERENCE long-term extension (which admittedly have limitations) and real world studies to show the incidence rates in patients who have AD but are not treated with a JAK inhibitor vs those who are treated with a JAK inhibitor. Spoiler alert: not much of an appreciable difference.