At Strategikon Pharma, we bring a high level of precision and speed to outsourced clinical trial operations through our flagship SaaS platform, Clinical Maestro. Our digital solutions enable sites to be more productive, with online study training, study eBinders (eISF), digital study alerts and SUSARs, patient visit guides, and a wide range of study tools, available via web portals and mobile apps. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve live. http://www.celerion.com. actalentservices.com, To learn more , please visit our website - March 07-09, 2016 Madrid, Spain. With locations in the US and EU, Catalyst offers highly flexible and customized, customer-centric solutions from Global Resourcing and FSP, to Full Service Managed Solutions, with a focus on oncology product development. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. Collaterally with her Regional Food and Drug Director duties, Anne served as the acting program director for both the Biologics and Tobacco programs during significant planning phases for program alignment. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. http://www.yprime.com/, To learn more , please visit our website - Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables. Developing and supporting your quality initiatives from Day 1, the Harbor team is committed to quality through each functional service we provide. Fusion eClinical Suite is the most adaptable, unified platform that serves as the Connected Hub for all your Clinical Trial and operational data and reporting. Presently, Ndidi is the Associate Director, Clinical Quality Assurance & GxP Compliance at Ultragenyx Pharmaceutical Inc. where she has worked for over 6 years. Debashish earned a PhD in Computer Science from the State University of New York at Buffalo, specializing in the application of AI techniques in document analysis. Phase 1 Trials: How to globalize to accelerate value inflection. Helping you take advantage of the speed of study start-up and R&D tax incentives in Australia and allow for smooth trial transition in the US. To learn more , please visit our website - www.versiticlinicaltrials.org, Viedoc designs engaging software for the life science industry. deep6.ai, To learn more , please visit our website - To learn more , please visit our website - Partnerships in Clinical Trials Europe 2020. With headquarters in Dublin, Ireland, ICON employed approximately 41,150 employees in 113 locations in 53 countries as at September 30, 2022. Axiom Exhibiting at Outsourcing in Clinical Trials Southeast 2022. North Carolina, Raleigh-Durham 4 - 5 Apr 2023 . In addition to several peer reviewed publications and patents he published two volumes on, Process Chemistry in the Pharmaceutical Industry and currently is working on the third volume entitled, Bioprocessing, Bioengineering and Process Chemistry in the Biopharmaceutical Industry jointly with the bio-process leaders at Pfizer. Dr. Marszewska earned her MSc and PhD degrees in the field of chemistry. www.medocity.com, To learn more , please visit our website - We are a certified Minority Business and always do the right thing. Founded in 1976, ACRP is a Washington, DC-based non-profit organization with more than 13,000 members who work in clinical research in more than 70 countries. She is currently managing a Ph3 program in rare liver disease. www.advarra.com. Explore and learn more about Conference Series : World's leading Event Organizer. http://citlabels.com/. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. How best to go about educating the patient community? In this position, she focuses on initiatives for employee development or training and topics to advance health literacy for underserved communities as it relates to clinical trial access. Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. https://www.q2labsolutions.com/, You need an Imaging Strategy thats designed and customized for your oncology clinical trial. For over 35 years Parexel has been a trusted global clinical research organization (CRO) and biopharmaceutical services company. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. To learn more , please visit our website - https://www.parexel.com/. Founded in 1985, Promedica International, a woman-owned corporation, is headquartered in Orange County, California. Combining patient-reported health data, personal medical records, and conversations in the Inspire community uncovers critical insights unattainable with traditional research methodologies. Subsequently completed a Neurology Residency at Columbia University with additional Fellowship training in Neuro-Oncology at the Mass General Brigham program. TrialMaster, IRMS MAX, and TA Scan, the companys flagship products, lead the way in reducing complexities in the drug and device discovery and commercialization process. He was Senior Director of Clinical Operations at Pharmacyclics from 2012 to 2017 where he was responsible for the development, implementation and maintenance of the Clinical Operations infrastructure, as well as the GCP inspection hosting platform and processes, and regulatory authority marketing approval inspection hosting. She became the Deputy Program Director for OMDRHO in 2017 and ultimately became OMDRHO Program Director in February 2022. To learn more , please visit our website - Dr. Apfel is an internationally known authority on designing, conducting, and publishing highest quality clinical trials with thousands of patients that have changed medical practice with over 100 peer-reviewed publications. He is also a co-founder of U&D Pharma and working on Replyte Gel, a treatment for anogenital warts. The Technology track will seeKimberley Ferguson(Commercial Head of Personalized Healthcare Partnerships, Genentech) discussing all thingsWearables. 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. To learn more , please visit our website - AWT Healthcare is solely focused on providing the clinical pharmaceutical and custom labels & packaging industry with state-of-the-art solutions at a fair price and competitive timing. www.viedoc.com. http://www.labconnectllc.com/. Vial is a next-generation CRO that leverages the nationwide Vial site network to ensure faster, higher-quality trial outcomes for sponsors. To learn more , please visit our website - Peachtree BioResearch Solutions is an Atlanta-based Clinical Research Organization that provides clinical development support services and innovative resourcing solutions to medical device, pharmaceutical, and biotech companies. Dr Jasmina Jankicevic is globally recognized as an expert in dermatology drug/device development. He received his medical degree (MD) and his doctoral degree (PhD equivalent) from Justus-Liebig-Universitt Giessen, Germany, and his Master of Business Administration (MBA) from the Wharton School of Business, University of Pennsylvania, PA. Kunal Sampat is the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. His last company, TheraSim, trained over 1 million physicians worldwide and was sold to WebMD in 2013. Clinical Services. The Association of Clinical Research Professionals (ACRP) supports clinical research professionals through membership, training and development, and certification. He has worked for CROs as well as small and large biotechnology companies. The 15th annual conference will provide experts in the life science industry to connect and explore solutions to current operational and outsourcing challenges associated with clinical trials . Also within Genentech, she is a core member of the Advancing Inclusive Research Site Alliance and leads the company's LGBTQ+ Health equity strategies. To learn more , please visit our website - She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. Anca has over 15 years of experience in the biopharmaceutical industry, working both on the CRO and the Sponsor side. As the Founder and Chairman, he spearheaded the ACS ProSpectives international conferences on, Process Chemistry in the Pharmaceutical Industry, and as the chair, speaker and the moderator at numerous national and international conferences on API Process Chemistry, ADCs and Drug Discovery & Development. www.saama.com. PANEL DISCUSSION: Decentralized/Hybrid Trials: Discussing the current challenges and debating best practises for a successful virtual study, Considerations and best practices in direct-to-patient (DTP) / decentralized clinical trials (DCT) lessons learned from past trials, PANEL DISCUSSION: Reversing the Conversation What the clinical trial industry really wants from its service providers, KEYNOTE A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around, A playbook for how to handle an undesirable CRO-Sponsor partnership & how to turn it around. Estela has worked in healthcare for over 30 years, currently supporting private practices with electronic medical records, office workflows to help the practice and patients for a top leading healthcare organization. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences. http://www.altasciences.com/, To support the acceleration of drug development, over the last 12 years, ARENSIA Exploratory Medicine GmbH (www.arensia-em.com) has built up its own research clinics, with full Phase I infrastructure, entirely dedicated to the performance of sophisticated FIRST-in-PATIENT Phase IB, IIA and PROOF OF CONCEPT clinical trials with novel compounds. To learn more , please visit our website - ARENSIAs outstanding recruitment performance across numerous disease areas substantially reduces the overall number of sites and countries for any early-phase patient trial. Since our establishment in 2004, we have conducted over 700 phase I clinical trials, with 80% of our clients consisting of US based biotech and pharmaceutical companies. Mural Health is a participant management platform that helps manage & streamline the trial experience for patients and caregivers. To learn more , please visit our website - www.medpt.com. To learn more , please visit our website - www.maxisit.com/ctos/. The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. Ops components of various FIH studies and global P1-P3 drug development programs and post-marketing studies in Oncology, Hematology-Oncology, Immuno-Oncology, Infectious Diseases, Immunology, Metabolic Diseases, Ophthalmology, and Critical Care conducted in North America, Europe, Africa, Central and South Americas, Asia-Pacific regions including Japan, China, So Korea, and Australia *Lead cross-functional teams and successfully contributed to several INDs, NDAs, FDA, EMEA, TGA, and NMPA regulatory filings and approvals of marketed products within HIV/Virology Therapeutic Area *Mentor, motivate, and develop clinical operations teams and direct reports *Strong, flexible, strategic team leader with extensive change management successes *Track record to develop, problem-solve, and execute creative and innovative process improvements and quality efficiencies within development operations *Motivated and driven to continue contributing to drug development in transformative medicines with a focus on unmet medical needs, CLOSING KEYNOTE: ClinOps team focus: Managing relationships, retention and hiring in the new world. Reimbursement for medical devices in trials, and, understanding the process. TFS demonstrates scientific and medical competence across populations and therapeutics, with industry-leading capabilities in: -Dermatology, Immunology and Inflammatory Diseases, -Internal Medicine including Neurology & Respiratory, -Pediatrics, Rare Diseases and Orphan Drugs, Detailed information about TFS, and its business offerings can be obtained through.
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