How Do Visual Patient Profiles Help Medical Reviews in Complex Oncology Trials?

Clinical Trials, Life Sciences, Pharmaceutical,
  • Tuesday, June 11, 2019

Patient-level insights help medical reviewers and drug safety monitors review a patient’s overall clinical trial experience in a detailed manner while visual patient profiles represent a combination of the important CDISC domains. Aligning the two next to each other helps the end user correlate events in one domain with findings in another domain.

The clinical operations team reviews a patient profile to ensure consistency with the case report form (CRF) and source document verification, gaining a bird’s eye view of the patient’s experience. The medical reviewer uses the visual patient profile to summarize the interactions of the compound with other factors, including vital signs, laboratory test data and the relevant CRF. Visual patient profiles:

  • Help reviewers to write the patient narratives needed for submission
  • Facilitate reviews of patients with serious adverse events
  • Provide access to the overall holistic view of the patient rather than comparing individual case report forms
In this webinar, learn about the benefits of visual patient profiles in helping medical reviews in complex oncology trials. 

Speakers

http://Dr.%20Ashok%20Srivastava,%20ClinFomatrix,%20Cure%20Pharmaceuticals,%20Inc.

Dr. Ashok Srivastava, CEO & Chief Medical Officer, ClinFomatrix, and CEO, Cure Pharmaceuticals, Inc.

Dr. Ashok Srivastava has more than 17 years of experience in drug development, medical affairs and commercialization of cancer drugs, including radiopharmaceutical and supportive care, Phase I – IV trials and marketing commercialization of immuno-oncology, hematology, oncology and radio pharmaceutical drugs in the US, EU and Japan. He is a leader in cancer drug development worldwide for Phase II and III clinical trials in many countries. He contributed to 21 Investigational New Drug applications (INDs) and seven New Drug Applications (NDAs) of cancer drugs and supportive care — acquisition/merger of pharma and drugs worth more than $300 million.

Dr. Srivastava played a key role in the dramatic expansion of oncology drugs and developed numerous cancer drugs: Sutent (Sunitinib), Evoxac (Cevimeline HCl), and liposomal doxorubicin (Myocet) in combination with Herceptin and Paclitaxel for HER2 positive metastatic breast cancer patients. He also developed Latuda (Lurasidone) for schizophrenia. He is one of the inventors of the Japanese encephalitis vaccine (IXIARO).

Dr. Srivastava is a leader in innovative, generic and biosimilar drug development, drug safety, pharmacovigilance of hematology, oncology drugs and he has built global drug safety and pharmacovigilance companies in the US and India. Dr. Srivastava was invited as an honorable speaker to Drug Safety & Pharmacovigilance Congress events in the UK, US and India in Jan 2012, 2013 and 2017. He has brought two cancer drugs and a vaccine in global market for approx.  $3 – 3.5 billion global sales.

Dr. Srivastava has published more than 85 papers in national and international journals, more than 120 abstracts, three book chapters and has written two patents. He is recipient of numerous national and international medical awards and recognition from the United Nations, Ministry of Health, Japan, and Department of Army, Walter Reed Army Medical Center and Walter Reed Army Institute of Research, Washington DC, USA. He served as medical advisor to Poniard Pharmaceutical for small cell lung cancer in the US, EU and India.

Dr. Srivastava is a member of numerous prestigious organizations: America’s Top Oncologist of the years 2007- 2011, Breast Cancer Foundation, Indian Society of Oncology, American Society of Clinical Oncology, American Society for Therapeutic Radiology & Oncology, American Association of Cancer Research and International Society of Lung Cancer. He is a strategic medical advisor and a board member for several U.S.-based pharma companies. For those companies, he provides clinical/regulatory support, and supervises cancer drug development.  Dr. Srivastava  serves as board of directors for oncology pharma companies in USA.

He received clinical, medical training and worked at renowned medical centers and pharmaceutical institutions worldwide, including Walter Reed Army Institute of Research and Medical Center, Daiichi, Sumitomo, Pharmacia, Pfizer, Sopherion Oncology, Eisai Oncology and Spectrum Pharmaceuticals. He received clinical, medical and business education from All India Institute of Medical Sciences, New Delhi, India; Academy of Medical Sciences, Czech Republic; School of Medicine Nagasaki University, Nagasaki, Japan; and Pharmaceutical Business at Rutgers University Business Management, New Jersey, USA.

Message Presenter
http://Nithiya%20Ananthakrishnan,%20OmniComm%20Systems,%20Inc.

Nithiya Ananthakrishnan, Senior Vice President of Data Sciences, OmniComm Systems, Inc.

Nithiya Ananthakrishnan founded Algorics and is now senior vice president of Data Sciences at OmniComm Systems, Inc. He is responsible for the development and delivery of the Acuity platform to meet clinical data analytics and risk-based monitoring (RBM) requirements. He joined OmniComm as part of the transaction in which OmniComm acquired certain assets of Algorics, and its flagship solution Acuity, which allows researchers to assess and capture the risk profile for a clinical trial and map risks to intelligent actions as part of RBM. As a sought-after speaker and moderator, he has delivered thought-leading presentations to prestigious industry groups around the globe.

Message Presenter

Who Should Attend?

Senior professionals who review patient-level data for safety and efficacy during clinical trials in the following departments:

  • Clinical Development/ R&D
  • Clinical Data Management
  • Data Monitoring & Management
Relevant job titles include:
  • Chief Medical Officer
  • Central Monitor
  • Medical reviewer

What You Will Learn

Attendees will gain insights into: 

  • Roles of medical reviewers and drug safety monitors in clinical trials
  • The benefits of visual patient profiles, which include the ability to:
    • Help reviewers to write the patient narratives needed for submission
    • Facilitate reviews of patients with serious adverse events
    • Provide access to the overall holistic view of the patient rather than comparing individual case report forms

Xtalks Partner

OmniComm Systems, Inc

OmniComm Systems, Inc. is a leading strategic software solutions provider to the life sciences industry. OmniComm is dedicated to helping the world’s pharmaceutical, biotechnology, contract research organizations, diagnostic and device firms, and academic medical centers maximize the value of their clinical research investments. Through the use of innovative and progressive technologies, these organizations drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance. With an extensive global experience from more than 6,000 clinical trials, OmniComm provides comprehensive solutions for clinical research. Please visit www.omnicomm.com for more information.

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account