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Kristyna Sedivakova Email
Principal Medical Writer . iNGENū CRO
Melbourne,
Locationk******************@ingenucro.com
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▶ WHAT WE DO:\n\niNGENū CRO delivers FDA-compliant clinical trials for US Biotechs and saves them 70% of their clinical trial costs... WITHOUT the lengthy timelines typically associated with clinical trials.\n\nWe manage all the heavy lifting to ensure that our clients can focus on what they do best – creating life-saving treatments.\n\n▶ OUR FDA-EXCLUSIVE FOCUS:\n\nAs a full-service CRO, our team members have the experience of hundreds of clinical trials behind them. Our unique, FDA-exclusive focus has created a CRO performing:\n1. Clinical Trials (Phase I, II, and III)\n2. IND-Enabling Non-Clinical Studies with Data in FDA-Compliant SEND Format\n3. FDA Regulatory Submissions (PIND, IND, NDA)\n\n▶ WHY WORK WITH US:\n\n1. Government Grant Access: As an Australian CRO, all our clients (clinical and non-clinical) will receive up to 43.5% government R&D Incentive to perform their research with us.\n\n2. Fast, High-Quality Research: We excel in conducting fast-paced research that strictly adheres to FDA guidelines and regulations. We ensure that our clients' timelines are met without sacrificing quality.\n\n3. FDA Regulatory Expertise: With extensive experience in FDA regulatory work, we specialize in making full FDA pre-IND and IND submissions for our clients. \n\n4. Diverse Therapeutic Specialty Leaders: Our team comprises physician and scientific specialists with expertise in a wide variety of therapeutic areas, enabling us to provide highly tailored solutions that meet the unique demands of your clinical trials.\n\n▶ OUR TYPICAL CLIENT:\n\nAn early-stage US biotech company who is looking for:\n\n• >70% cost reduction on FDA-compliant clinical and nonclinical trials\n• All data being 21 CFR 312.120 compliant for US FDA submission\n• Clinical trial startup time in 8-10 weeks\n• Commence FIH clinical trials prior to opening an IND\n• Perform rodent and second-species nonclinical studies at a fraction of the cost of the US\n\n▶ READY TO TALK? \n\n☎️ Like to find out more? Book a time to connect with us.iNGENū CRO Address
Melbourne, null
Australia