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Meet our Powerhouse duo for the 20th BioPharma Clinical Trials Nexus San Diego🌟 Join Jacqueline Dessibourg, PharmD, Founder and President of Sierra Peak Medical Affairs Advisors and Melody Keel President of The Research Associate Group Inc. as they share insights on "Clin Ops and Medical Affairs Collaborations: Optimizing Trial Engagement Outcomes" Don't miss this vital discussion shaping the future of the industry! #NEXUSconference #ClinicalTrials #MedicalAffairs #Collaborations #BioPharmaNexusConference #ProcurementDirect #SanDiegoConference

There are 3 main phases of clinical trials – phases 1 to 3. Phase 1 trials are the earliest phase trials and phase 3 are later phase trials. Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed Sneha Pol #Clinical Trial #medical life

The application of platform, enrichment and adaptive designs can deliver innovative therapies to patients, faster and more efficiently. My colleague Cecil Nick, VP (Technical) Parexel Regulatory Strategy explores how we can advance clinical development through innovative trial design, with intensive planning and close interaction with regulatory agencies. Find out more about platform trials, basket trials, umbrella trials, enrichment designs, and adaptive trials – with practical examples of each, and their application in different therapeutic areas, in this new white paper.

Key performance indicators are very important tools to assess an institutional success versus a set of targets and objectives. We invite you to read this important and interesting article by Dr. Nagwa Ibrahim that illustrates the impact of KPIs in improving clinical pharmacy services. This article had the highest views and downloads last month. Nagwa Ibrahim

The real essence of #Clinical #Pharmacy services is the provision of individualized and tailored #pharmacotherapy, keeping in view the big picture and utilising clinical judgement based on current evidences. It is and should not be from screen or notes. #Look at #patient, spin your brain, take the decision.

FDA publishes draft guidance on collecting demographic data for clinical trials and clinical studies 🌐 The FDA has just released a draft guidance on collecting demographic data for clinical trials and studies. Titled "Collection of #Race and #Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products," this guidance aims to standardize data collection, ensuring consistency in submissions to the FDA. https://lnkd.in/egwhwqaD #clinicalresearch #clinicaltrials #clinicaloperations #regulatoryaffairs #RAPS #ACRP #clinicaldevelopment

𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴 𝗖𝗹𝗶𝗻𝗶𝗰𝗔𝗜: 𝗬𝗼𝘂𝗿 𝗔𝗜 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗖𝗼𝗺𝗽𝗮𝗻𝗶𝗼𝗻🌟   Pharma, medical device manufacturers, and CRO companies are exploring ways to speed up and improve the clinical trial process. We are excited to introduce 𝗖𝗹𝗶𝗻𝗶𝗰𝗔𝗜 – our GenAI solution designed to accelerate clinical trials. As a robust medical document processing engine, ClinicAI supports various functions such as: 📄 Summarizing clinical trials 📝 Generating consent forms ❓ Addressing requests ✅ Conducting patient eligibility checks   Watch the full video to discover how 𝗖𝗹𝗶𝗻𝗶𝗰𝗔𝗜 can streamline your clinical trials: https://lnkd.in/eNvR-Bf4   #DataArt #ClinicAI #ClinicalTrials #LifeSciences #GenAI 

FDA publishes draft guidance on collecting demographic data for clinical trials and clinical studies 🌐 The FDA has just released a draft guidance on collecting demographic data for clinical trials and studies. Titled "Collection of #Race and #Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products," this guidance aims to standardize data collection, ensuring consistency in submissions to the FDA. https://lnkd.in/egwhwqaD #clinicalresearch #clinicaltrials #clinicaloperations #regulatoryaffairs #RAPS #ACRP #clinicaldevelopment

Clinical trials are the foundation for medical advancements, relying on a complex behind-the-scenes operation: the clinical supply chain. This specialized system manages everything from developing to delivering investigational drugs to trial sites. It's a critical dance with patient safety and research integrity at stake. Read more in our new POV from Aditya Gupta, Mahendra Salshingikar, Nilay Srivastava >>https://lnkd.in/dvWMagNb #clinicaltrials #healthcare #research #patientcare #supplychain Srinivas Chilukuri | Ed Francis | David Champeaux

Our Chief Executive Officer, Robert Barrow, and Chief Medical Officer, Dr. Daniel Karlin, provided commentary on the recent FDA guidance on clinical trials with #psychedelics in a bylined article published in the September 2023 edition of MedNous (Evernow Publishing Ltd). The new guidelines provide a framework for conducting scientifically rigorous trials to assess the safety and effectiveness of the drug class. They represent a significant step forward in clarifying the regulatory and R&D expectations in the use of psychedelic drugs for potential treatment of medical conditions including #brainhealth disorders. You can read the full article here: