Archer Research’s Post

Alas, there is no "A" or "I" in EUCROF" so we are missing AI in the list. I am sure we will be setting up a couple of sessions on the subject. So, if you want to tell the world how AI is changing clinical research, please send us your abstract.

EUCROF25 – where pharma, biotech, medical device companies, CROs and other service providers will come together……   EUCROF25 will bring together pharma, biotech, medical device companies, CROs and other service providers, technology providers, regulators, patients, and academia, to discuss the current challenges, and future direction of Clinical Research across Europe.    Save the date for EUCROF25: 2-4 February 2025   If you want to find out where it is, then head to the conference website at https://lnkd.in/e8bt2cqG Dr. Martine Dehlinger-Kremer, Simon Lee, Martin O'Kane, Sverre Bengtsson, Benedikt Van Nieuwenhove, Alexandre Malouvier, Antonio Torres, Nicole Bohrmann, Fiona Maini, Cristina Florescu Moraid, Alan Yeomans, Nira Garty   #EUCROF #clinicalresearch #clinicaltrials #clinicaloperations #gcp #bigpharma #dct #EUCROF25

EU Clinical Trials Regulation…Outsourcing…Operational Aspects…ICH…DCTs…or something else…What would you like to discuss at EUCROF25……   The Call for Abstracts at EUCROF25 will provide you with a chance to have your say on the full range of clinical research topics, and share your views and expertise to representatives from pharma, biotech, medical device companies, CROs and other service providers.   The call for abstracts is set to open shortly for EUCROF25. More details to follow.   If you want to find out where EUCROF25 will be held, then head to the conference website at https://lnkd.in/e8bt2cqG Dr. Martine Dehlinger-Kremer, Simon Lee, Martin O'Kane, Sverre Bengtsson, Benedikt Van Nieuwenhove, Alexandre Malouvier, Antonio Torres, Nicole Bohrmann, Fiona Maini, Cristina Florescu Moraid, Alan Yeomans, Nira Garty   #EUCROF #clinicalresearch #clinicaltrials #clinicaloperations #gcp #bigpharma #dct #EUCROF25

During #DIA2024, I was honored to sit down with Dr. Peter Marks and get his thoughts on how the industry is fairing 2024, as well as his vision for the future. ➡️ Watch the Full Interview: https://lnkd.in/ga_z9spj #regulatory #clinicaltrials #rarediseases #AI #FDA #globalcollaboration .

MEDIcept White Paper: First Quarter 2024 Clinical 483 Inspection Observations are Tracking to 2023 Trends. How to Stay Ahead with a Winning Strategy! 2023 Clinical 483 Inspection Observations Trends Are you curious about different ways to avoid a 483 violation? Then this MEDIcept Inc. White Paper is for you! Each year, FDA compiles a list of 483 inspection observations into a dataset, summarizing ways companies have violated FDA regulations throughout that fiscal year (FY). In fiscal year 2023, there were 720 observations issued for medical devices, 45 for biologics, 96 for human tissue for transplantation, and 158 for bioresearch monitoring included in the dataset.  In this paper we present the top 6 clinical inspection observation trends identified in FY 2023; which section of the federal regulations were violated; and how sites, sponsors, and/or contract research organizations (CROs) can implement strategies to minimize the possibility of receiving a 483 violation when an FDA inspector knocks on their door.  Click the link below to read the White Paper written by Elizabeth Braschayko, MS, Clinical Project Manager, and Emily Sawtell, Associate Medical Device Consultant. https://lnkd.in/eQfrw-rG Do you want to start implementing strategies to avoid regulatory non-compliances and findings, but you are not sure where to start? MEDIcept has an experienced CRO who would be glad to assist you. Reach out to us today at sales@medicept.com to get started! #clinicaltrials #CRO #483violation #FDA #observation #trends #medicaldevices #whitepaper

In March, the Medical Device Coordination Group (MDCG) published its new document: “Guidance on the Content of the Clinical Investigation Plan for Clinical Investigations of Medical Devices” 📋📊 The MDCG 2024-3 guidance aids sponsors in crafting their CIP by providing detailed descriptions of the information expected in each CIP section. This preemptively addresses potential inquiries from competent authorities during the assessment of clinical investigation applications. 🔍 You can access the complete guidance document here 👇 https://lnkd.in/dedMGjT3 #ClinicalResearch #Innovation #HealthcareSolutions #BiTrial #clinicaltrial #medicalsupport #clinicalmonitoring #fullservicecro #cro #pharma #biotech #hungariancro #crohungary #mdcgguidance #medicalguidance #clinicalinvestigation

A challenge in #CGTdevelopment lies in the bespoke nature of these treatments, resulting in a multitude of proprietary solutions that demand extensive time and resources for both developers and regulators. Traditional drug development timelines and regulatory frameworks may not adequately accommodate the unique characteristics of CGTs, leading to significant delays and costs, particularly for rare diseases where patients have limited time for treatment. To ensure sustainability and broader access to CGTs, the industry must transition away from traditional approaches and streamline technological foundations to reduce costs and accelerate development timelines. A recent initiative co-sponsored by the Alliance for Regenerative Medicine and NIIMBL | The National Institute for Innovation in Manufacturing Biopharmaceuticals aimed to identify building blocks and platform technologies to streamline CGT development and regulatory review, with this whitepaper offering an overview of sector challenges, regulatory paths, and proposed building block solutions. Read more below! h/t to Lindsay Gasch, PharmD, BCPS, BCACP FDA https://lnkd.in/eU5tQwFj #cgt #fda #arm #NIIMBL #CDER #CBER #industrycollaboration #manufacturing #patientoutcomes #technologydevelopment

We invite you to the vibrant cities of Hague, London, Copenhagen, and Zurich to join me and my colleagues at the Outsourcing in Clinical Trials conferences. If you are a CRO, pharma, or biotech representative, join us. Also, it's truly heartening to see a focus on this critical aspect within our industry. #Sustainability in clinical trials is so important. I couldn't agree more! A sustainable vendor is as crucial to the clinical trial process as climate neutrality, intelligence, and vibrancy are important to a city's sustainability agenda, ensuring attractiveness and respect for its citizens. #ClinicalTrials #Outsourcing #Medicover #CentralLabServices #Conferences #Innovation #Collaboration #Healthcare #ResearchExcellence #Networking #sustainability

NEW: Outsourcing Pharma Webinar! ⭐"FDA guidance about improving diversity in studies has gained momentum and continues to do so. It has always been a goal of nearly every clinical research professional, but achieving it has been historically difficult, how has this changed since the guidance was issued. This webinar will discuss some of major changes but also the key obstacles that still stand in the way" ⭐Our very own Ann Graham was featured as a speaker on this Outsourcing Pharma Webinar! ⭐Watch/listen here: https://lnkd.in/gJNF36FN #MIBAgents #MakeItBetter #osteosarcoma #OutsourcingPharma

Set of very nice and useful tools for clinical research