SocraTec R&D

Our colleagues at SocraMetrics are experts in #DataManagement for #ClinicalTrials. Their in-house developed eCRF proves MedDRA coding excellence that greatly enhances #Efficiency. Find out more below and request a demo. 👇 #DataEntry #ClinicalResearch #EDC

📣 AGAH Introductory Course: Deep dive into Exploratory Medicines 📣 Only 26 days left until the AGAH Introductory Course in Exploratory Medicines Development enters its second round. We are delighted that our colleagues share their expertise in this intensive training: Ralph-Steven Wedemeyer will cover #bioequivalence, and Ruwen Böhm will delve into #biosimilars - both areas of our strength and daily work. We are happy to provide insights from our experience! This 4-day course offers a comprehensive overview of human pharmacology, covering various aspects - from assessment of non-clinical data to pharmacodynamic endpoints. Topics include study design, the molecular basis of drug action, and dose escalation. Registration is still open! If you’re interested or know someone who might be, don’t miss this opportunity on September 24th - 27th! 👉 register here: https://lnkd.in/eb2EEhQK #shareknowledge #clinicalresearch #clinicaltrials #drugdevelopment

Our colleagues at SocraMetrics have highlighted the great #efficiency of the MedDRA Coding Tool that is part of their #eCRF – a true benefit for clinical research! Find out more here 👇 #DataManagement #ClinicalTrials #ClinicalResearch

Behind the eCRF of SocraMetrics stands incredible know-how and passion! 👩💻 💙 This tool will be a benefit for your clinical trial: It is 🔹simple 🔹secure 🔹compliant Watch the video to see some of the features and stay tuned for weekly insights. #datamanagement #EDC #clinicalresearch #clinicaltrials

Consider your Patient population – already in early phase 👨👨👧👦 The FDA has released “Diversity Action Plans” as draft guidance: “Participants in clinical trials should be representative of the patients who will use the medical products,” said #FDA Commissioner Robert M. Califf, M.D.,[1] and sums up the intention of these recommendations. Clinical trials shall… 🔹Enroll representative populations with respect to specific demographic factors (e.g., #race, #ethnicity, #sex, #age group). 🔹Aim to increase #diversity in clinical studies (e.g., broadening of eligibility criteria) when scientifically appropriate.   This guidance is applicable for efficacy and safety studies, but already in early phase these principles are worth considering! We at SocraTec R&D are experts in study design and we love to support your trials - from planning to conduct and reporting! 💙     👉 find the FDA announcement here [1] https://lnkd.in/eT5AhNTP #clinicaltrials #earlyphase #clinicalresearch

⏳Countdown for CTIS Transition: 185 days to go! ⏳ In just 185 days, all ongoing clinical trials for EU must be transitioned to #CTIS (Clinical Trial Information System), replacing EudraCT completely on January 31, 2025 – we strongly advise not to wait with transition until the last minute. 🔷 The challenge: Conduct a CTIS transition for a multicenter, international clinical trial involving five European countries – Answering this sponsor’s request, we entered somewhat uncertain territory. 🔷The result: With quickly provided sponsor’s documents, we were able to prepare the submission in less than 14 days. Despite RFIs in the validation process for organizational reasons, we received authorization from the Reference Member State (Germany) within 8 days after valid application. All other Member States Concerned followed within a few days, completely transferring the clinical trial 50 days after submission – much shorter than a regular initial submission. 🔷The knowledge behind it: Since 2016, we were involved as stakeholder representing the EUFEMED in a User Acceptance Testing organized by European Medicines Agency, gaining intensive practical experience with the European database. Besides, the successful participation in the #EMA CTIS Master Program was a great preparation for us, interactively working on challenges, gaining insights and actively shaping the process of transition. 🔷Our assessment: CTIS aims to harmonise the submission of clinical trials in Europe – as #CRO we highly appreciate this goal that greatly advances clinical research by reducing bureaucracy. However, we still see potential in cutting down national specialties that still slow down the submission process. 🔷Our advice: Don’t wait until the last minute – start now! ⏰ 👉 Find an CTIS overview, provided by EMA here: https://lnkd.in/g9WF5ehy   #shareknowledge #clinicaltrials #clinicalresearch

✨ Comeback for Germany as pharmaceutical research location: Deutscher Bundestag passes #Medizinforschungsgesetz (Medical Research Act) ✨ We at SocraTec are delighted about this step to strengthen clinical research in Germany and recognizing the German research-based pharmaceutical industry as a key industry. The new law comes with: 🔹 Faster and less complicated conduct of clinical trials: Shorter approval times will speed up German research, making the country more competitive internationally. 🔹Commitment to local research is recognized: Companies that conduct research in Germany can be freed from barriers to innovation in the form of additional discounts and price caps. We are glad for this step that stabilizes clinical research in Germany and accelerates the availability of new therapies for patients. 💙 👉 Find the press release of the German Ministry of Health here (in German): https://lnkd.in/g47MRgsX #ClinicalTrials #ClinicalResearch #StarkAmStandort

We are delighted and honored to have been asked to produce a client’s instructional video for IMP handling! It was a pleasure for us to be filmed at our CPU in Erfurt and to help our client in supporting the trial sites with an explanatory video. Whether it is a scientific advice, study conduct or an instructional video – we are keen to support your clinical trial! 💯 Contact us with your (exceptional) request and we will do our best to meet your needs: 👉 https://lnkd.in/ep8v-iQ6 👉 info@socratec-pharma.de 👉+49 (0) 6171 58 57 1-0 #ClinicalResearch #ClinicalTrials #DrugDevelopment #ShareKnowledge

🚀 Fantastic news from German authorities: shorter approval times for clinical trials in Germany! This truly makes Germany more attractive to conduct clinical trials! 📈 #clinicaltrials #clinicalresearch #drugdevelopment

Our experts Maria Anschütz and Annika Dax shared their in-depth knowledge of trial medication at the AGAH e. V. introductory course in exploratory medicines development in Wiesbaden last week. Thank you for your efforts and dedication! 💯 #meetourexperts #shareknowledge #clinicalresearch #clinicaltrials