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.
Craig 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.
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 led 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.
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.
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.
Munther has over 30 years of experience in the pharmaceutical industry. He is currently the VP of Product Strategy and Innovation, provides strategic oversight, innovation, and development of products and technologies. Manages development team and creates product roadmaps, blending vision with data-backed research to ensure long-term competitiveness of product offerings. Plays an active role in business development initiatives and decisions related to product, business, marketing strategy, and deliverables.
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 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 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.
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