LLX Solutions, LLC (“LLX”) was founded in 2011 at Waltham, MA. Currently LLX has over 100 employees, mostly statisticians and statistical programmers, in our Waltham Headquarters and Guangzhou Branch. About 70 employees work in the Waltham Headquarters, and around 30 employees in the Guangzhou Branch.
In the past 10 years, LLX has served more than 40 clients in biotech/pharmaceutical and medical devices, and diagnostic industries, and provided top-quality services for 120 studies and 30 ISEs/ISSs, from phase 1 to phase 4, covering therapeutic areas such as oncology, neuroscience (CNS), autoimmune, heart diseases, lung diseases, kidney disease, rare diseases, etc. LLX team members have prepared SDTM/ADaM Define.xml for more than 300 studies and 30 ISEs/ISSs. LLX also helped multiple clients successfully submit their packages to the FDA (NDA and BLA), Health Canada, and EMA (MAA), 8 of them got approved by those regulatory agencies.
LLX Solutions is always focusing on building a collaborative, highly efficient, quality team. About 50 of our statisticians and statistical programmers have PhD and/or a master's degree in statistics or biostatistics; about 40 have a public health or computer-related master's degree and/or bachelor's degree in biostatistics, epidemiology, biology, and other disciplines. Around 20% of our statisticians/programmers have over 10 years' experience, and about 30% have over 5 years' experience. We provide comprehensive trainings on SOPs, CDISC, and other technical skills to all related employees.
LLX has fully implemented Quality Management System (QMS), which consists of Policies, SOPs and work instructions for biostatistics, programming, IT, and our general practices. Our IT infrastructure is a fully validated, Microsoft Azure hosted. Clinical trial data is encrypted and fully backed, and server is replicated for disaster recovery.
LLX is also working with partners and other service provides on EDC, clinical operations, PK/PD services, and medical writing. This cooperation will take advantage of our partner’s expertise and bring more complete, high quality services to our clients.