To learn more , please visit our website - Going the last millimeter: What you may not know about home visits. 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. Currently he is the CEO of Certum Bio in San Francisco Bay area and honors the co-appointment as the Member of the Board of Advisors, UC Berkeley Postdoc Entrepreneurs Program (BPEP). Jowita Marszewska, Ph.D. is a Scientific Advisor at Clario, a global data and technology company that helps minimize risk in clinical trials. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. Communities. We are known for our superior statistical leadership and data management expertise and proud to have supported thousands of studies across a diverse range of diseases. The Decentralized Clinical Trials hybrid event, April 18th - 20th in Boston, will provide leading insights and practical guidance on how to decentralize your clinical trials for greater diversity, accessibility and efficiency, with guidance a world-class speaker line up. Or has the noise around DCT quietened? atreo.io, To learn more , please visit our website - Boring clinical trials are better clinical trials. She has managed and overseen large global clinical trials in various therapeutic areas and multiple phases of development. https://www.almacgroup.com. Theyre more likely to finish on time and on budget. Actalent is a leading provider of Clinical and Laboratory services. After years of watching the opioid crisis develop, John has developed an innovative drug and dispenser to safely treat pain and deter abuse. With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/WRS) expertise at our core, our services are scalable via our strategic partnerships to provide full-service clinical trial solutions that are The Right Fit For You. Conduct of clinical trials are increasingly becoming expensive. Emvenio Research is transforming how patients and care-givers engage in and experience clinical research, To learn more , please visit our website - Emmes acquired Casimir in March 2022, and the . What things do they need a partner to do and what they dont need! Optimizing CRO Success: Relationship, contribution and oversight, PANEL DISCUSSION Defining your outsourcing strategy to contain costs and accelerate drug development time-to-market: what should you consider in the new COVID-19 era, Executing clinical trials on a shoestring: Optimizing the CRO Functional Service Provider model. Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. You might have known us as Myoderm as we have recently changed our name but not our high-quality services as the complete clinical trial supply partner. Meraf Eyassu is a Executive Director of Clinical Operations at Terns Pharmaceuticals. The impact DCT has on diversity, equality and inclusion (DEI) have we finally managed to tap into under-represented communities? https://www.slope.io/. 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. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval. April 28-29, 2016 Dubai, UAE. Frontageis a CRO providing integrated, scientifically-driven research, analytical and product development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. Francis has lead supplier oversight responsibilities for sponsors, CROs and clinical system vendors. She also has a special interest in innovations that can improve the quality and efficiency of clinical trial execution. We provide one of the broadest testing portfolios in the industry and this includes Safety & Efficacy testing, Biomarkers & Flow Cytometry, Cell based assays, Oncology/Pathology, Genomics, Virology, Immunology, Microbiology, Bioanalytical Services, early clinical development service and clinical trials supply. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience. Medocitys platform is the only solution that provides a fully interactive clinical trial ecosystem enabling early decision making and safety monitoring in real time. Meghan joined a CNS-focused start up in RTP and has spent the last 15+ years working in the life science technology industry. Our experienced team has been in this niche of clinical research with deep domain experience for decades and client solutions has been our passion for over two decades. Dublin, March 01, 2023 (GLOBE NEWSWIRE) -- The "Clinical Trials Outsourcing Market Share, Size, Trends, Industry Analysis Report, By End-Use, By Therapeutics Area, By Workflow, By Region, Segment . We integrate clinical operations excellence, laboratory expertise, and advanced data sciences to deliver on the promise of personalized therapy; translating research into real-world results and forever reimaging how to get there. What is critical to get right to make a digital QM System work? Patient Inclusion and Health Equity, Chief Diversity Office, Genentech, Vice President, In-Home Solutions, Decentralized Clinical Trials, PCM Trials, Executive Director, Clinical Operations, Terns Pharmaceuticals. The Patient Engagement track will be chaired byEstela Mata-Carcamo(Healthcare Advocate) and will delve into topics such as,outreach to minority groups,social determinants of health, and best practices forengaging the patient community. http://www.datacubed.com/. The 15th Annual Outsourcing in Clinical Trials New England event will bring together clinical trial professionals from big and small biopharma to uncover new technologies and processes, to optimize their clinical and outsourcing operations. Cognizing & mitigating Does AI-ML offer a solution? Slope makes clinical trials boring by using real-time data to orchestrate operational complexity. She leads the scientific development of digital clinical measures and the modernization of clinical development models under the banner Technology As Methodology. She has held key national leadership roles including advisor within the Obama/Biden administrations global HIV response team, advisor to United Nations leadership and instructor at the CDC and USAID. To learn more , please visit our website - www.pro-ficiency.com. Prior to her work at Potrero, she was the VP of Business Development at Theranova and led marketing initiatives for C. R. Bard (now owned by Becton Dickinson), in both Shanghai and the U.S. She has also worked as a Board Fellow at the American Red Cross Bay Area, currently serves as a guest lecturer at the University of California, San Francisco and Berkeley, and spent several years in sales and training at Johnson & Johnson. Dr. Apfel is also the Chair of Life Sciences at the Keiretsu Angel Investment Forum, where he invests in life-science companies that have the potential to positively impact patients with serious conditions. To learn more , please visit our website - Specializing in clinical development and staffing solutions, we offer a flexible approach to ensure our clients unique needs are supported. I went into industry for post-doctoral studies at the biotechnology research center at Ciba-Geigy Corp. (Novartis) and have over three decades of academic and industrial research and senior management experience in protein and metabolic engineering, bio-based manufacturing, and drug discovery / development. In this role, Mr. Chu develops, manages, and evaluates inspectional matters for DWCI covering all FDA import activities associated with air and sea port operations in the States of Hawaii, California, Nevada, Oregon, and Washington. Explore and learn more about Conference Series : World's leading Event Organizer. Add the event to your calendar. Dr. Karl McEvoy has over a decade of industry experience in both the vendor and sponsor sides. http://www.spauldingclinical.com/, To learn more , please visit our website - She has actively participated in departmental preparation for the EU CTR implementation and is one of ICONs SMEs on this topic. www.precisionformedicine.com. La Jolla, CA. http://www.cromsource.com/. The Digital Transformation of Clinical Trials the Importance of Data Accuracy. We do this by combining our 25 years of proven quality and results with expertise in 30+ therapeutic areas, a flexible approach, and dedicated teams who enable rapid startups and fast timelines. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. The elluminate Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. The 2014 event will focus on how companies from the region can implement effective clinical outsourcing strategies. To learn more , please visit our website - To learn more , please visit our website - http://www.premier-research.com/. Our latest enhancements include patient genetic and biomarker matching to promote swift site identification and patient enrollment. www.emvenio.com, To learn more , please visit our website - We have expanded our product line to include Medical Device Labeling through AWT Labels & Packaging. KEYNOTE: Seeing your site as a partner and identifying best practices for reducing site-burden, Seeing your site as a partner and identifying best practices for reducing site-burden, Clinical Operations leader with extensive bio-pharmaceutical and CRO industry experiences (20+years) *Develop and implement strategic Clin. 200+. Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideasinto reality. www.viedoc.com, To learn more , please visit our website - ACM performs more than 20 million laboratory tests each yearspanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more. Any Disease. Basel, Switzerland. Visit our website to learn more about how we deliver a Better Clinical Experience. Saama Technologies is the advanced clinical data and analytics company, unleashing wisdom from data to deliver better actionable business outcomes for the life sciences industry. To learn more , please visit our website - He also conducted undergraduate research on osteoporosis progression and has authored several papers, abstracts and a book chapter on protein signal transduction. Our performance is built on years of experience staffing the competitive biopharma job recruitment landscape, leveraging our deep networks to source the most highly sought-after candidates in the industry. Sun, 24 Apr 2022, 09:00 End. Our Leukopaks are available for Research Use Only and Clinical Grade (FDA 21 CFR 1271-compliant) applications. Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. He works cooperatively and collaborates with Federal, State, and local agencies to ensure appropriate consumer protection. Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. To learn more , please visit our website - Medocitys platform captures valuable real-time clinical insights & real-world data, while engaging patients, sites, and sponsors. Cultural consideration - translations, typical distance from site, etc. Scalable, Reliable. Technology as a methodology: Accelerating Clinical Development timelines. Our scientific knowledge base, technical expertise and reputation for high quality services have been integral to our ability to turn our services into your solutions. Myonexis a global complete clinical trial solutions provider. http://www.medpace.com/. Altasciences full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management and more, all of which can be tailored to specific sponsor requirements. Genentech Chief Diversity Office, Patient Inclusion And Health Equity. See Our Products. Join us in Philadelphia, May 10th-11th, to shape best practice on: Refining patient recruitment strategy. To learn more , please visit our website - https://www.threadresearch.com/. https://www.sdcclinical.com/. She is a Nurse Practitioner by training and spent over 10 years caring for patients before coming to industry. To learn more , please visit our website - Altasciencesis a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. Register. Tactical clinical operations in digital health studies, First-hand learnings, breakthrough device system, a case study. He received a Certificate for Graduate Biostatistics at Harvard University Extension. After completing her education in England, Ndidi began her career working for Parexel followed by Merck Sharp & Dohme. 10th International Conference on Clinical Trials is scheduled to be held during August 04-05, 2022 at Vancouver, Canada. www.td2inc.com. Clinical Trials Innovation Programme 2023 is the only platform to . To learn more , please visit our website - https://lifesciences.transperfect.com/. Making progress of a complex Interventional device study during covid. Global Clinical Trials Connect 2023 2022 London United Kingdom RxE2 Releases . IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. She has executed a variety of clinical trials involving therapeutic areas including autologous breast reconstruction, heart failure, hypertension, arrhythmia management and erectile dysfunction. San Diego Marriott La Jolla. 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. February 27, 2023. To learn more , please visit our website - https://www.threadresearch.com/, To learn more , please visit our website - 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. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date. TORONTO, March 23, 2022 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ("Axiom"), a premier provider of unified eClinical solutions . Jay holds an MBA from Villanova University and a degree in Computer Science and Physics from Gettysburg College. Clinical Technologies. To learn more , please visit our website - http://www.novotech-cro.com/. 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. This conference intends to focus on the global health and clinical trials around the world. 5 th Clinical Nutrition Conference. Ndidi Rickert is an experienced Quality Assurance leader with over 20 years of experience in the Pharmaceutical/Biotechnology industry. www.zigzagassociates.com. 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. August 29-31, 2016 Atlanta, USA. We develop new innovations, drive emerging therapies forward and improve patient lives. Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. The two day programme will take a holistic approach to the latest challenges and innovations in clinical operations, such as, the [] www.clinone.com, To learn more , please visit our website - The Outsourcing in Clinical Trials Texas event aims to be a solution-driven conference that allows Clinical Operations professionals to network with innovative vendors, hear cutting-edge content, and participate in interactive discussions. Discuss a pathway to extend biotech cash burn runway while still meeting Phase I objectives and meeting investor expectations! To learn more , please visit our website - Chris has dedicated his 16-year career to the services side of the Phase I clinical drug development industry, including both operational and business development roles. Due to increased utility of digital data collection tools and compute infrastructure, ability to generate real-time insights are now possible. Clinical Outcome Assessments (COAs): Applying scientific rigor and good instrument design. He worked as a Research Associate to improve recruitment metrics in the Million Veterans Program genomic biobanking initiative for Loma Linda VA Medical Center where he developed a novel Point of Care recruitment solution in outpatient clinics. 21 October 2022 Outsourcing In Clinical Trials - Texas 2022. Eurofins BioPharma Services, Laboratory Testing is a group of Eurofins companies with dedicated testing facilities for global Central Laboratory Services, Bioanalytical Services, and Specialty Virology and Oncology Services. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch. To learn more , please visit our website - Finding patients is a challenge. Mr. Luciano joined Corvus Pharmaceuticals in 2018 and has served as Vice President of Clinical Operations since 2021. She has driven program strategy and planning, including implementation of 300+ clinical study protocols in 25+ indications, by leading global cross-functional teams towards successful regulatory submissions, product launches, and innovative lifecycle management. Other companies he has founded or co-founded include: 1) IMTH, a real estate investment trust with properties through the state of California; 2) iPill Dispenser, a medical device that uses a mobile app to control a secure, stand-alone pill dispenser to prevent opioid sharing, diversion, and drug overdoses; and 3) NAOMI systems, a practice management software company that integrates digital X-rays devices in PACS, EMR and RCM billing modules. How do you arrange with and clean the large amounts of data generated? To learn more , please visit our website - KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS, and Normal Sinus Rhythm in an ECG. www.advanceresearch.com. Developing successful communication pathways in a more remote world. 30+. http://www.yprime.com/, To learn more , please visit our website - Should our biggest concern post-covid be remote working? Their experienced research team comprises key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. 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. The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. Sandy Mohan is the VP of Quality at Iovance Biotherapeutics. To learn more , please visit our website - CROMSOURCEis unparalleled in offering an end-to-end guarantee covering trial timelines, enrollment, and price. www.bsi-lifesciences.com. Reem holds a PhD in genetics from the Hebrew University of Jerusalem. The global clinical trials outsourcing market size is expected to reach USD 67.62 billion by 2030, according to a new study. Passionate about novel tech-enabled medical devices that advance the understanding and treatment of diseases. Why expert partners and staff matter; what metrics dont tell. To learn more , please visit our website - 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. Dont miss out; join us in Burlingame on March 1st& 2nd2023! www.ledgerrun.com/, To learn more , please visit our website - Hear from the trial industry as they discuss the services they would like to see from their solution providers, including: Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. http://www.cluepoints.com. To learn more , please visit our website - BDO Releases 2022/2023 CRO Insights Report. Outsourcing In Clinical Trials . We have access to a population of over 10.5 million people across all 3 sites, and the ability to offer a multi-site solution in recruiting participants and patients to our clients. Our Provider Edition offers a CRO costing module and bid benchmarking. To learn more , please visit our website - April 18-20, 2016 Dubai, UAE. Program and Alliance Management professional with 15+ years of product development, project management and operations experience within the biotechnology and biopharmaceutical sectors. https://www.trilogywriting.com/. She is driven by listening and incorporating the patient voice and by finding innovative ways to improve the patient experience. Our comprehensive solutions include clinical trial management technology and services (TMF services, eTMF, CTMS, regulated content management, etc. Featuring solutions for automated referrals, eConsent, patient engagement, connected devices, eCOA, and eSource, ClinOne makes participating in a clinical trial a little easier, every day. He received M.Sc. Making the patient stories the centre of your study with a focus on feedback, Important topics to address with patients, Best timing and approach to successfully engage patients. His clinical trial experience spans from set-up to delivery across all phases in a wide variety of disease and therapeutic areas. Vice President, CMC and Supply Chain, Union Therapeutics, Umar Hayat, Ph.D. is VP of CMC and Supply Chain at Union Therapeutics and has more than two decades of experience in pharmaceutical development, manufacturing and supply chain. Analytical & Solid State Services. Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Casimir's research on the development of the Duchenne Video Assessment (DVA) scorecards was published in PLOS ONE. Fun fact: Ndidi was born and raised in Sierra Leone, and is a descendant of the Krio people who were freed slaves that returned to Freetown from Africa, America and The West Indies. This conference will focus on topics such as bioethics, regulations, patient recruitment, site selection, data integration & strategy, and many more. medtech.labcorp.com. The Budget Conundrum. Estela is an exceptional community engagement liaison for both English and Spanish speakers. To learn more , please visit our website - Spaulding Clinical Research is a global CRO providing Phase I IV drug development services to pharmaceutical and biotechnology companies. Catalyst Clinical Research is a new generation Clinical Research Organization, serving the unique needs of small-to-medium sized biopharmaceutical companies. Her background in Biotechnology and proficiency in Data Management solidified her proven ability to identify data integrity risks, and problem solve the most complaint path to drug submissions and approvals. To learn more , please visit our website - Meghan started her career as a Masters level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. 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. Anne came to FDA in 1990 with an undergraduate degree in Biochemistry and a masters degree in Food Science and segued into FDAs laboratory science regulatory operations. 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 . Outsourcing Clinical Trials New England 2022. Developing and supporting your quality initiatives from Day 1, the Harbor team is committed to quality through each functional service we provide. Valley Fever Solutions is a small startup working first on a new and improved treatment for Valley Fever (coccidioidomycosis), for which NikZ will transform the standard of care. Richard holds a Ph.D. in Industrial Engineering with a focus on applied statistics, quality, and reliability engineering from Arizona State University (ASU), a Master of Science in Industrial Engineering focused in Operations Research and Production Systems (ASU) and a Bachelor of Science in Engineering in Industrial Engineering (ASU), and is certified as a Six Sigma Black Belt. As the worlds largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.
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