NexGen eSource: EHR-EDC Integration – Clinical Data as a Service – The Game Changer

Clinical Trials, Life Sciences,
  • November 10, 2015

Hands typing on laptop computerToday, clinical research staff are spending significant hours of effort transcribing data into the Sponsor’s EDC systems and then followed by managing queries, resolving discrepancies and sometimes creating redundant work effort. Currently there is a lag of 15-20 days in available to the sponsors.

The now changing dynamics of clinical research and health care focuses on the importance of the EHR, EMR and PHR to the field of Clinical Research, Healthcare, and Regulations and most importantly to the patient. The significance of integrating data from its source and enabling it for downstream data science and analysis can be highly impactful in the future evolution of modern medicine through research and science.

Wipro and OmniComm Systems have developed an integrated system – Digital Integrated Clinical Enterprise platform – that connects EHR and the research systems to ease and simplify EDC data capture process supporting clinical research to enable faster completion of study, reduce the cost of development.

Benefits Include

  • Faster time to market: Potential to reduce drug-to-market time by up to 12 months.
  • Significant reduction in monitoring visits: Reduces CRA visits resulting in cost savings per visit including reduction in SDV.
  • Improved quality of clinical data: Appropriate patient selection, efficient addressing of research queries and improved data accuracy leads to approximately 60% decrease in queries/re-work.
  • Better resource utilization/ optimization: Automated processes reduce data entry efforts by 50% and increase CRA time spent with the study team on the study effectiveness.
  • Increase the Patient safety: As we deliver the data in near real time, sponsors will be able to make faster decisions and improve the patient safety.

Speakers

Rao Teki, PhD, Global Head, Pharma R&D Innovation Solutions Group, Wipro

Dr. Rao Teki brings in over 25 years of experience in high-end consulting to Pharma and Life Sciences industries. He developed many business innovation and transformation solutions to address the current challenges of the industry – faster time to market and reduce the cost of development. With the experience as Physician and Life Sciences industry thought leader, he is instrumental in building Digital Integrated Clinical Enterprise (DICE) – EHR-EDC Integration, a Game Changer. Prior to this role, Dr. Teki established full services CRO in New Jersey and ran operations for 9 years. Earlier he practiced as a Physician, attended to many trauma patients during the Gulf War as a first responder. Dr. Teki is a medical graduate, is well known in the industry as a thought leader and an invited speaker. He also received award from President of India and a member of medical team for President and Prime Minister of India. He also received award from President of India and a member of medical team for President and Prime Minister of India.

Ken Light, EVP of Transformation and Professional Services, OmniComm Systems, Inc.

Ken Light is EVP of Transformation and Professional Services at OmniComm Systems, where he oversees projects to support technology transfer, integration, training, migration and business process improvement for the global Life Sciences community.

Prior to joining OmniComm Systems, Ken oversaw similar clinical strategy and technology consulting practices for Oracle Corporation, BusinessEdge Solutions, and First Consulting Group. For the past twenty years, Ken has delivered technology and business strategy services to the majority of top twenty Pharmaceutical manufacturers, along with many smaller health and life sciences organizations. Mr. Light has an M.S. in Computer Science from Fairleigh Dickinson University, and a B.S degree from the State University of New York at Binghamton.

Who Should Attend?

  • Heads of Clinical Data Management
  • Heads of Phase I Clinics
  • Heads of Operations
  • Heads of Clinic Systems
  • Heads of Clinical Pharmacology

Xtalks Partners

OmniComm

OmniComm Systems is a leading strategic software solutions provider to the life sciences industry. OmniComm Systems is dedicated to helping the world’s Pharmaceutical, biotechnology, CROs, research and medical device organizations maximize the value of their clinical research investments. Through the use of innovative and progressive technologies these organization drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance. OmniComm provides comprehensive eClincal solutions from Phase I through late phase clinical trials with an extensive experience with over 4,000 clinical trials.

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