She is mastering the logistics of dosing and testing clinical trial participants where they live, work, and study. Dr Jankicevic holds Doctor of Medicine degree, Master of Medical Sciences degree, and Board-certification in Dermatology and Venereology from the University of Belgrade, Serbia. This conference intends to focus on the global health and clinical trials around the world. www.bsi-lifesciences.com. Our biotech recruiters, pharmaceutical recruiters and scientific recruiters provide multiple solutions spanning temporary and permanent placement to clients ranging from venture-backed start-ups to Fortune 500 firms. His father was a physician who developed an interest in the disease decades ago when the family moved to Bakersfield, California, a focal area for the disease. To learn more , please visit our website - https://www.propharmagroup.com/. The Calendar Industry Events and Conferences, including SPECIAL DISCOUNTS Coming ATTRACTIONS The 5th Annual Outsourcing in Clinical Trials East Coast Conference will convene in Philadelphia in May 13-14, 2014. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date. Join thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking . He is a key member of the leadership team responsible for defining the company's go to market strategy and value proposition across the many segments of the pharmaceuticals and device research industry. She currently serves as Vice President of Clinical Affairs at Endogenex, a medical device company developing innovative solutions for the treatment of Type 2 diabetes. Making progress of a complex Interventional device study during covid. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. We work With HeartTMevery day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. Read more. Clinical Trials Innovation Programme 2023 is the only platform to . Oversight with less presence how to make this work, Effectively building strong working relationships remotely, Strategies to deliver training and upskill your team, Handling hard discussions with your CRO/partner when you cant meet in person, Optimizing communication channels/effectiveness with your CRO partner and team, Maintaining a positive working relationship prioritizing and building strategies from the outset, Clinical trial timelines are lengthy and on average a Phase 3 trial can take between 1-4 years. This experience has allowed her to understand the nuances that set rare and pediatric studies apart from routine clinical studies and develop proper strategies for clients to execute their studies in real world settings. He has worked for CROs as well as small and large biotechnology companies. Zigzag aims to provide straightforward, reliable and flexible Quality Assurance and auditing services on a local or global basis. Day 1 will kick off with a talk on designinga playbook for how to handle an undesirable CRO-Sponsor partnership, followed by a Keynote Panel allowing attendees to debate how to optimize theiroversight & governance, led byAbby Kennedy(VP of Clinical Operations, CymaBay Therapeutics). http://greenphire.com/. Pharmaceutical Development. Basel, Switzerland. OMDRHO's Key Initiatives, inspectional and compliance activities, Define RWE and real-world data sources/needs, Making progress during pandemic for a first-in-human device study, Designing a hybrid trial for a novel interventional device, Navigating the complexities of multi-specialty study, Determining the technologies to move studies off site in order to move forward with the new norm, Investigating technology to save costs and improve accuracy of pharmacokinetic and pharmacodynamic data, Learning how to improve study drug adherences so only the study participant has access and, can only take the drug as per study protocol, Case Study looking at Digitization for objective data and cost saving, Defining the reimbursement strategy to prove medical benefit and value, Understanding codes for medical device technologies, Working with the FDA to secure your reimbursement, Programming for efficient data management, Generating metrics for data tracking and study progress, Overview of how we interface with our organization, Discussing the technologies accessible for the smaller biotechs, Assessing how to make access to innovations affordable for companies on a smaller budget and how to best allocate limited resources, How to work with a vendor partner as a smaller biotech to get access to new technologies, Removing the barriers: what still needs to be done to improve access to innovation for all, Key drivers for trial enrolment and in time completion, Population and high prevalence of disease in developing countries, Barriers and hurdles to access vast pool of patients, Strategies/solutions to penetrate through barriers and pass hurdles, Common operational, security and regulatory issues around the collection, management, and reporting of essential clinical trial documents, How eTMF solutions can help to address these issues, and ensure inspection-ready and regulatory compliant storage of trial content, How eTMF solutions reduce business risk, improve team collaboration and productivity, reduce auditing and reporting costs, and ensure enhanced artifact quality, Major capabilities that current eTMF solutions should provide. Over the years, Lin has achieved success at both large corporations and startups. http://www.medpace.com/. Genentech Chief Diversity Office, Patient Inclusion And Health Equity. Aug 09 International Conference on Drug Development, Clinical Trial Phases and Technology (ICDDCTPT) - Lagos, Nigeria. Local vendor oversight vs global provider oversight how would you manage this differently? www.advarra.com. . To learn more , please visit our website - Jowita Marszewska, Ph.D. is a Scientific Advisor at Clario, a global data and technology company that helps minimize risk in clinical trials. AliveCor, Inc. is transforming cardiological care using deep learning. We offer customized solutions to fit the needs of each study, patient and site, making it easier for your patients to stick with it. Theyll ensure your translations will be of the highest quality, on time, and within budget. Includes management of the RFP process for outsourced services as well as contract/proposal and budget negotiations, vendor selection, and vendor oversight/relationship management. www.viroclinics.com. 2022 looks to be a bumper year too, so Nature Medicine asks leaders in their field what they think . KPS is a global, innovative, Clinical Outsourcing Provider delivering clinical trial monitoring, management and quality oversight services to pharmaceutical, biotechnology, medical device, and related industries. A significant portion of the cost in a clinical trial can be attributed to operational conduct of the trial such as site monitoring related activities, data management and site oversight. We are committed to delivering high-quality, cost-effective services according to sponsor timelines and specifications. Combined, our clinics offer over 200 beds. Finding patients is a challenge. To learn more , please visit our website - Decentralized Clinical Trials 2022 was a really good opportunity to . Operating in 49 countries across the globe, KPS Life is committed to working together with its clients through a hands-on operating model rooted in a partnership approach. To learn more , please visit our website - Our innovative network of Mobile Research Sites, At Home Visits and Technology Enabled Virtual Visits are a unique blend of global DCT capabilities that can be deployed to better reach, recruit and retain diverse patient populations, while improving their clinical trial experience. eurofinscentrallaboratory.com/biopharma-services. With over 15 years experience in the industry, Esther has predominantly worked in clinical trial management and data management roles across Europe, North America and South Africa. TFS HealthScience is a global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. www.td2inc.com. www.harborclinical.com/. API Services & Chemical Development. To learn more , please visit our website - He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding and Grants solutions. We help teams bring order, trust, and predictability to protocol execution and automation. Are you planning to attend the upcoming Outsourcing in Clinical Trials New England, November 9-10th, 2021? Extensive Outsourcing and Contracts experience in the area of Clinical Development primarily at small to mid-size biotech organizations. Theyre more likely to finish on time and on budget. Best practices and tools for managing supplier governance and ascertaining who is accountable, Identifying the criteria to determine level of oversight needed for a vendor. Proven track record of coordinating teams in order to meet tight deadlines, set and communicate expectations, and manage deliverables. ), both from Duke University where I was also an undergraduate. I am the CEO at OrPro Therapeutics, a biotechnology company in San Diego, CA developing biologic drug solutions to unmet needs in serious epithelial diseases including cystic fibrosis. Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. KPS Life (www.kpslife.com) is a stand-alone, global functional service provider (FSP) that offers a clinical outsourcing solution across all phases of clinical drug development. The news service . Experienced in research methodologies and conducting qualitative and quantitative research in a variety of therapy areas including respiratory, cardiology, oncology, immunology rare diseases and emerging therapy areas. THREADs platform and supporting services are helping customers to shorten study launch timelines, reduce study budgets with Virtual Visits, and bring studies from the clinic to patients homes. Home / Events /. He has been actively involved on both sides of the business in managing CDMOs and CROs. This talk will provide an overview of the application of Artificial Intelligence methods in clinical operations. How do we move forward from here? eClinical & Clinical Data Management Innovation Conference 2022 . From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. April 18-20, 2016 Dubai, UAE. Kunal has over 18 years of experience managing and conducting clinical trials. The event is a must-attend for people from the clinical trials . AWT Healthcare manufacturers clinical trial labels. To learn more , please visit our website - To learn more , please visit our website - Dr. Raymond completed her doctoral training in molecular biology at University of California San Diego and post-doctoral training in molecular biology at Memorial Sloan-Kettering in New York City, New York, USA. Headquartered in Sydney since 1996, Novotech has come to be recognised as the CRO of choice for many US and European biotechnology firms in the Asia Pacific. www.assistek.com, To learn more , please visit our website - With 2,000 annual trials and projects, around 200 active clients and global access to source drugs in over 60 countries,Myonex is your complete partner around clinical trials around the globe reliable, trusted and by your side. To learn more , please visit our website - Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc. With presentations and panel discussions on all the hottest industry trends and outsourcing challenges. Her clinical development experience spans all therapeutic areas and all stages of the clinical development lifecycle, from natural history studies through registrational global trials, and Long-Term Follow Up and Post Marketing surveillances. She is currently Director of Patient Safety Medical Device for AstraZeneca and supports products across the enterprise. www.prevailinfoworks.com. Deep 6 AI is the leader in precision research software, connecting all research stakeholders in an AI-powered, real-time, data-driven, collaborative ecosystem. http://www.clindatrix.com/. Our Provider Edition offers a CRO costing module and bid benchmarking. Join us in Philadelphia, May 10th-11th, to shape best practice on: Refining patient recruitment strategy. To learn more , please visit our website - www.saama.com. More recently, Arun headed to Santen, with a focus on driving operational excellence in Ophthalmology clinical research as Associate Director Global Clinical Development and Operations, where he oversees Phase 1 4 clinical trial conduct. Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. Infectious disease clinical trials; Biometrics functional outsourcing; We also provide: Drug development consultancy and services to assist the development plan of molecules in early clinical phases; Clinical pharmacology units, bioanalytical laboratories and trial management offices across Europe and North America to perform your clinical . February 27, 2023. 28 - 29. ProTrials works with sponsors in the pharmaceutical, biotechnology and medical device industries to deliver high-quality clinical development services in a wide range of therapeutic areas. www.signanthealth. We have expanded our product line to include Medical Device Labeling through AWT Labels & Packaging.