Chris Elsheikhi’s Post

Why the need for phase 3 trials? Go from phase 2 straight to phase 4 PASS or PAES. As, statically EMA only approve around ~2.1 of all product submissions regardless of #CHMP opinion. This is huge for phase 4 PASS and phase 4 PAES studies required aka demanded post phase 3 studies. I was at the patient safety forum at ESMO in Spain. No one could get taxi because Spain in Barcelona didn't have enough taxis. I attended a patient group and they want access regardless of safety concerns or protocols. Or informed concent which is key. They want access to the options for treatment vs biostats skewing the numbers and which are more negatively inclined around a CHMP positive opinion. Patients are demanding and don't like the restrictions imposed on them by patient informed consent. And, legal jargon in the ICF. Most clearly would take their chances and be tested vs animals and not being excluded from having the option vs clinical trial protocol exclusion criteria. They'd rather clinical trials had more inclusive criteria. I've attended a DSMB hearing and I was rejected. Not sure Worldwide DSMB based in Belgium. Is really Worldwide...

✈ COG Europe 🗓 10-12 October COG Europe is underway in Milan. Our Key Account Managers, Pawel Drozd, and Nunzio Formisano are exhibiting at Booth 20 and will be on hand to advise you about our end-to-end clinical trial services 💊 A friendly pair, if you have any questions as to how we can support your clinical trial, why not pop by and introduce yourself – they may even give you an #OxiBear to take home 🏠 #COGEurope #COGSeries #ClinicalTrials #ClinicalTrialsLogistics #COGEurope2023

Only 15 days to go! ⏱ Everybody who has registered for the GCSG European Knowledge Forum in Athens can already look forward to meeting my colleagues Gayatri Gopal and Ram Mahalingam to learn how you can optimize and automate the clinical supply process with SAP Intelligent Clinical Supply Management. #clinicalsupply #GCSG #meetus #SAP #ICSM

RT: IPK Leibniz-Institut The Eucarpia General Congress takes place from 18 to 23 August 2024. Due to many requests the abstract submission deadline and the early-bird registration deadline has been extended to May 13th. 📌All details: https://lnkd.in/eQ4GHjsT #plantbreeding #breeding #breeders #seeds #yield #yieldgap #Genomics #biotechnology #resistance #climatechange #plantpathology ...

Did you catch Michael Cartwright's session at the PSI 2024 Conference today? Network and ask your questions regarding the pivotal role of Data Monitoring Committees in ensuring the integrity and safety of clinical trials. #ParexelWithHeart #DataScienceInHealthcare #ClinicalTrialsInnovation #PSI2024 #PSIAmsterdam

Important Update RE the 7th European Conference on SVA

I love expanding my horizon, and so I truly appreciated starting the new year with a visit to the Phase I Unit of CRU Global Network in Budapest yesterday! You'd be surprised by how much organization goes into making sure a phase I unit runs smoothly! A few highlights for me include: 👉 Having an IT setup that reflects, and grants access to both patients and staff, the exact study schedule of the patient to meet all timelines. For me, from a transparency and patient/participant involvement point of view, this is a great tool to keep everyone aligned! 👉 IT system that contacts the staff in case study time points passed without activity registered in the system! 👉 Color-coded rooms to make communication with patients and in case of emergencies smoother than using room numbers. 👉 Strictly controlled access to all rooms (and the exit door). 👉 Well-organized system to track all the samples taken during a study. 👉 Checking response time in case of emergency. 👉 Surveillance of common areas to ensure that no patient fainting goes unnoticed. Thanks for guiding us through the facilities, Peter Kovacs dr. and Adrian Dorko! And great to connect again, Dr. Petr Svrcek! Hope you have a safe trip back. #clinicaltrials #phase1 #GCP

Event | IVDR Q&A time 📢❓At what stage should we start to ask for the institutions' help? The registration link is still open for reviewing the webinar 🔗 https://lnkd.in/gMStTd-P #IVD #IVDR #QandA #stayinformed #Europe #medicaldevice