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
President and CEO
Jian Chen, President and CEO 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.
Senior VP, Product Development and Strategy
Peter Smilansky, Senior VP, Product Development and Strategy 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.
VP, Global Head Information Technology and Security
Anatoly Podstrelov, VP, Global Head Information Technology and Security 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.
Director, Business Architecture and Analysis
Dan Golden, Director, Business Architecture and Analysis Dan is a results-driven leader with extensive experience in enterprise software delivery and the Life Sciences. He brings over 20 years of experience in eClinical software and solutions delivery to his role. Dan has core experiences in program and project management, computer systems compliance, regulatory compliance strategies, and product management. He works with EDETEK’s business analysts, architects, internal subject matter experts and product engineering group to develop functional requirements for new applications, translate business requirements, ensure GxP and 21 CFR Part 11 compliance and develop specifications for information integration within CONFORM™. Dan holds a Masters in Information Technology from American Intercontinental University.
Global Head, Program Management
Yulia Zayarnaya, Global Head, Program Management Yuliya has 10+ years of experience in IT and software development industry in various domains and areas, both from business (retail, e-commerce, travel, publishing, health care) and technological perspective: from support and operation services to Public Cloud Migrations and custom development on Salesforce platform. Prior to joining EDETEK Yulia worked as the Head of PMO and was in charge of establishing best PM practices across the entire technology organization (200+ employees). Also within this role she concurrently managed multiple projects, and at the same time acted as a crisis manager for the projects in the red zone. Yuliya strongly believes that well established processes and strong communities/networks are the keys to the successful delivery. Besides project management Yuliya enjoys old school electronic music, synthpop, long walks in the city parks and good fiction novels.
VP Product Strategy and Innovation
Munther Baara, VP Product Strategy and Innovation Munther Baara is the product strategy and innovation lead as well as EDETEK’s major industry partnerships. Munther has 25 years of experience in leading the development of numerous clinical systems and business solutions. He has held roles of increased seniority in biotechnology and in the world’s largest pharmaceutical companies, leading global teams and technology implementations. Munther’s experience has been focusing on innovation, trends and emerging technologies in support of the paradigm shift in the execution of clinical trials. Munther was most recently the head of New Clinical Paradigm at Pfizer where he led and/or contributed to transformative technological breakthroughs. Munther also worked on mClinical patient journey (mobile and sensor), blockchain, returning data to patients, Shared Investigator Platform (SIP), clinical aggregation layers, eSource (Industry-Pioneering EHR Data Transfer) and TransCelerate BioPharma Projects. Also, he was awarded the 2018’s Top 20 Innovators in clinical trial advancements by CenterWatch.
Global Head, Product Implementation Services
Michele Cherry, Global Head, Product Implementation Services Michele has over 20 years of experience in leading teams in a variety of disciplines. Most recently, she led global teams and technology implementations for one of the world’s largest pharmaceutical companies. Her remit spanned clinical development subject and operational data, as she partnered with business leaders to define strategy and execute on the delivery of clinical data solutions. Michele’s experience includes a focus on innovative solutions to transform the execution of clinical trials. She recently led Pfizer’s eSource (Industry Pioneering EHR to CRF Data Transfer) Program as well as co-leading TransCelerate BioPharma’s eSource Tech & Standards working group. Michele partnered with pharma, academic institutions, regulators and industry to advance the use of electronic source data in clinical trials while advocating for the maturity of HL7 FHIR standards for research. Examples of her work included: eSource (EHR to CRF; electronic sourcing of eCOA, wearable devices and central labs data); clinical aggregation layers; operational data stores; auto generation of safety narratives; industry common protocol template implementation).
Director, Statistical Programming
Jing Liu, Director, Biostatistics and Data Management Jing 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. Jing holds a Master of Science in Biology from Tsinghua University.
Product Strategy Advisor
Craig Lipset, Product Strategy Advisor Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). He currently serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, and, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Craig is an Adjunct Assistant Professor in Health Informatics at Rutgers University.
Director, Product Development
Theodora Sarver, Director, Product Leader 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
Director, Statistical Programming
Haicui Wang, Director, Biostatistics and Data Management 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.
Beijing Branch Office
No 8, Zhongguancun Software Park
Rm 101 Huaxia Science & Tech Building
Haidian District, Beijing, China 100193