About us

Our History

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 300 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, CONFORM™ eClinical and CONFORM™ Informatics, 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.

Key Facts

eSource Data Integration Hub, DCT Orchestration, Data Aggregation, Review and Visualization, 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

Key Facts

eSource Data Integration Hub, DCT Orchestration, Data Aggregation, Review and Visualization, 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

Leadership Team

Jian Chen

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.

Dr. Shakthi Kumar

Chief Strategy and Business Officer

Dr. Kumar possesses extensive experience, having occupied numerous significant leadership positions such as CEO, EVP, VP & COO, and co-founder in various healthcare and life sciences organizations and startups. His expertise encompasses life sciences (pharmaceutical/biotech and medical devices) and healthcare (health systems, providers, and payers), focusing on business solutions that bridge the gap from "molecules to patient care." In recent years, Dr. Kumar has focused on fostering innovation and acceleration of therapies across the life sciences continuum and driving adoption of digital/AI across care pathways. He recently held the position of Senior Advisor at Bain and Company and is a board member of several Life Sciences and Healthcare companies. His past roles include Worldwide Head of Healthcare and Life Sciences Business Development at Amazon/AWS and EVP and Head of Life Sciences and Healthcare at Capgemini. Dr. Kumar earned a Doctorate in Health Administration from the Medical University of South Carolina with an interdisciplinary clinical focus, an MBA, and has a background in neural networks and computer engineering. Additionally, he is an adjunct faculty member for MD/MPH students specializing in global medicine and health policy and also dedicates his time as a board member to various community organizations.

Craig Lipset

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.

Anatoly Podstrelov

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.

Yulia Zayarnaya

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.

Michele Cherry

Vice President, Product Support and Implementation

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).

Jing Liu

Senior 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.

Haicui Wang

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.

Denise Redvers-Higgins

VP, Data Management

30+ yrs of experience in Clinical Data Management working for both sponsors and CROs. Leadership of EDETEK’s data management team of up to 60 employees. Knowledge of wide range of therapeutic areas, strong expertise in oncology and GCDM principles. Experience with system validation, SOP generation and bid preparation

Headquarters

101 College Rd E #200
Princeton, NJ USA 08540
Phone: (609) 720-0888

Beijing Branch Office

No 8, Zhongguancun Software Park
Rm 101 Huaxia Science & Tech Building
Haidian District, Beijing, China 100193
Phone: 86-010-62938810

Chengdu Branch Office

233 Jiaozi Street, Bldg D, FL 6, Room 612
Gaoxin District, Chengdu, China 610000
Phone: 86-028-62090613

EDETEK is the leading provider of digital clinical trial solutions, including high-quality technology platforms and related services for life sciences teams. As a CDISC Registered Solutions Provider and AWS Life Sciences Partner, we help clients transform data into assets. Our clinical data platform, COMFORM™, offers unparalleled advantages by improving data quality, increasing compliance, decreasing clinical trial costs and fueling efficiency across the clinical data life-cycle.

    Phone:(609) 720 - 0888
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