EDETEK was founded in 2009 by Jian Chen and incorporated in the state of New Jersey. The company was created for the purpose of building and marketing highly specialized software and corresponding services addressing the needs of Clinical R&D for the Pharmaceutical, Biotech, and Medical Device industries. We are a US based organization headquartered in Princeton, NJ with additional offices in the US, Asia, and Europe. The Headquarters office houses the corporate leadership team and key US-based personnel. EDETEK employs over 100 people globally.
Our Mission and Vision
EDETEK provides comprehensive business and technical solutions to advance the science of medicine and improve the quality of life of people around the world. We utilize our clinical platforms, Panther CTMP™ and CONFORM™, to fulfill our clients’ data engineering and business analytics needs. Our comprehensive metadata driven solutions, coupled with our extensive experience, knowledge and capabilities allow us to offer unparalleled advantages in data quality, time to completion, and cost efficiency.
ISO 9001-2008 Certified; Study Conduct, Data Management and Statistics for all Phases of Clinical Development; Experience in a wide variety of Therapeutic Indications, Support for IND’s, NDA’s, BLA’s, PMA’s, 510k’s; CDISC “Gold Member” and Registered Solution Provider; Active member of Six CDISC Working Groups: SDS, ADaM, CDASH, ODM, CT, Share; Prepare Hundreds of SDTM, ADaM and TFL Study Packages, Study Statistics and Data Conversion for Legacy and Live Studies Annually; Completed 10 Statistical Submission Packages (including ISS/ISE) 2015-2016; AWS Life Sciences Partner
Our Leadership Team
Jian is the visionary who started EDETEK. Jian is the cornerstone of our team just as the MDR he architected is the cornerstone for the EDETEK CONFORM™ Platform. Jian has 20+ years of experience in information management, statistics and business intelligence. Previously, Jian was the co-founder and CTO of Q-Square Business Intelligence, Inc.
Jian’s vision has leveraged the advancements in information technology to revolutionize existing business processes. The EDETEK CONFORM™ Platform provides a seamless integration of process and data (both structured and unstructured), allowing researchers to focus on business applications, as opposed to simply technology implementation.
Jian has an MBA Finance and Strategy degree from Columbia University, and an MS Biostatistics and Biomedical Engineering degree from Medical College of Virginia, School of Medicine.
Peter has 25+ years of Information Technology experience in the Life Sciences industry. Peter leads the Product teams to ensure the EDETEK CONFORM™ Platform vision and philosophy is applied throughout. Throughout his career Peter participated in some of the industry’s most visible R&D business technology projects. Peter brought to production numerous eClinical, business process management, scientific activity monitoring and data warehousing applications into clinical trials. Peter is one of the key industry contributors to establish regulated clinical systems to the Public Cloud environment, and is a frequent presenter at industry conferences.
Previously Peter lead development and implementation of multiple systems for a top pharmaceutical, managed application architecture in a global R&D organization, directed clinical and preclinical IT for biotech, and served as the lead clinical systems architect for a CRO, and he managed a clinical technology consulting practice for a global systems integrator.
Peter has a Master’s Degree in Applied Math and Computer Sciences from the University of Kiev.
Anatoly oversees global technology, cloud, security and product operations and he is dedicated to delivering and managing EDETEK’s innovative suite of clinical platforms. As a technology leader, Anatoly brings over 25 years of experience which spans multiple industries and business verticals. Prior to joining EDETEK, Anatoly worked in both small startups and large established companies, including leadership positions at SmashFly, where he was responsible for navigating company’s technology team through rapid growth cycle; and global brokerage firm ITG (now Virtu Financial), where he was architecting, building and operating best of breed SaaS platforms for financial services industry.
Anatoly has a Master’s Degree in Computer Sciences and Electrical Engineering from St. Petersburg Polytechnic University.
Theodora has over 20 years of experience in developing strategies and roadmaps in FDA regulated environments. She successfully delivered a number of SaaS, custom, B2B and B2C products within the clinical trials, healthcare and medical device industries. Theodora worked with various product teams and organization groups towards process delivery optimization and fostered product management and development best practices throughout her career.
Prior to joining EDETEK, Theodora served as the Manager of Product Management at Almac Clinical Technologies. At Almac, she managed multiple product lines and was responsible for executing the full product roadmap and strategy from inception to commercialization and maintenance. Prior to Almac she held various technical and product management positions for several medical device and healthcare software companies.
Theodora holds a BSc degree in Electrical Engineering from University of Thessaloniki, Greece and a Master’s in Biomedical Engineering from Drexel University
Mark leads Business Development activities designed to bring the EDETEK CONFORM™ platform, which is a technology based solution, to our target clients. Mark has 20+ years of experience in Business Development. His expertise lies in bringing innovative technology based solutions and technologies to pharmaceutical, bio-pharmaceutical and medical device companies who are actively engaged with improving the patient experience, using technology to enhance clinical data quality and looking for solutions that drive down drug to market timelines. His experience with prior SaaS based companies covers the full clinical operations process.
Eric brings over 20 years of Clinical, Safety and Omics Data Warehousing expertise to his role at EDETEK. As part of the product development leadership team, he is responsible for the overall delivery, design, business and technical specifications of EDETEK’s leading edge event driven clinical informatics platform.
His experience includes IND/NDA submissions, Regulatory, Quality Control, Clinical Trial Management and Electronic Data Capture. His experience also includes research and design of R based models and statistics packages for data mining. He has extensive knowledge of the informatics and analytics components of the R&D/Clinical processes. Eric holds an M.S. in Bioinformatics from the University of Maryland.
Haicui has more than eight years of experience as a clinical research professional with a strong background in CDISC standards including CDASH, SDTM, ADaM, Define, and BRIDG. Haicui’s skills span the data lifecycle including data analysis, data management, data mining, report designing and survey analysis. She has managed more than 300 phase I-IV clinical trials for clients across many therapeutic areas including oncology, CNS and infection. Haicui holds a Bachelor of Art in English and is pursuing a Master of Business Administration from Beihang University.
Huaijun has extensive experience in product development processes and managing technology teams. In his role at EDETEK, Huaijun is responsible for leading the Beijing software engineering team. He has successfully leveraged his technical expertise to design, develop, test and implement innovative technology solutions and leans on his leadership skills to motivate the team toward customer-focused solutions. Huaijun earned a Bachelor of Engineering in Material Forming and Control Engineering from Beijing University of Aeronautics and Astronautics, School of Mechanical Engineering and Automation.
Xiaoping is a passionate and energizing leader who strives for excellence and efficiency, and always delivers results! She has 25 years of dynamic experiences in pharma/biopharma industry (Sanofi 12 years, BMS 8 years), with in-depth work on phases I, II, III clinical trials, and submissions and approvals in Oncology, CV, Respiratory, Bone Disease, and CNS areas. She has taken increased roles and responsibilities in her career, as a statistician, statistics director, biometry director, R&D (Sanofi Pasteur China) Site Manager, statistical programming and data science director, and VP of biometry. She has also repeatedly built/developed high performing teams, including 2 from scratch. Xiaoping joined EDETEK in January 2019.
Xiaoping is Harvard trained with a doctoral degree (Ed.D) in Applied Statistics, and a post-doc fellowship from Educational Testing Service. She was a recipient of China’s National Scholarship for Oversea Graduate Studies, as well as Harvard Graduate Student Scholarship.
Jing Liu, MS, Biology has provided statistical programming support for hundreds of clinical studies involving all phases (I-IV) and a wide range of therapeutic areas, including oncology, dermatology and infectious disease. She is well-versed in CDISC standards and has led SDTM/ADaM/TLF and regulatory documents preparation for approximately 100 studies and 10 successful NDA/BLA submissions. Jing is comfortable collaborating with clients to address the complex statistical data requirements of clinical research. She holds a Master of Science in Biology from Tsinghua University.
Yulia Zayarnaya Senior Program Management , Product Development