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Clinical Trial Efficiencies at ShareFest 2013

By  Michael Agard Michael Agard  on 2013-05-09 07:34:00  |  Featured in  Life Sciences
Michael Agard
Posted By Michael Agard
in Life Sciences
on 2013-05-09 07:34:00

At ShareFest this past week, a major theme centered around improving clinical trial and health care efficiencies. Many of the speakers and vendors presented ideas for cloud solutions, apps, devices, social media and collaboration to enhance the clinical trial process. This article will examine potential efficiences in the clinical trial process from the perspective of several stakeholders.

1. Clinical TrialTeam Member

  • Electronic Trial Master File (eTMF) based on SharePoint such as NextDocs
  • Clinical Trial Management System (CTMS) based on SharePoint such as BioClinica
  • Remote risk based monitoring - using data from dashboards and data analytics
  • Remote meetings with site personnel and CROs using Lync, and Webex

2. Doctor/Investigator Conducting a Clinical Trial

  • Collaborative authoring of a clinical protocol using tools to extend the authoring and review process
  • Social media to increase patient recruitment using Facebook and Twitter
  • Special interest groups to facilitate disease understanding and treatment such as Yammer
  • Single-sign on to a portal and related applications using Exostar technologies
  • Digital signatures, paperless office using CoSign and SAFE BioPharma
  • Use of mobile devices to enter patient data and documents using tablets

3. Patient in a Clinical Trial

  • Retrieval of all individual patient data in a system such as the Health Vault
  • Entry of data using a smart phone or web portal
  • Virtual meetings with the physician using web cams
  • Use of apps to assist in the management of the disease or treatment

4. Regulatory Submission Publishers and Reviewers at Health Authorities

  • PDF renditions that enable full text searching using Adlib tools
  • Bookmarks, views and hypertext links to facilitate navigation and ease of reading
  • Submission publishing tools based on SharePoint
  • Data analytics to support safety and risk analysis.

It seems clear that social media, mobile tools, and cloud sharing bring significant opportunities for engagement all along the health care development process. Efficiency gains will become necessary to manage outsourcing, staff reductions and electronic medical records. However, there are risks and barriers to the full adoption of these technologies:

  • Data privacy of both individuals and corporations
  • Access management to the correct information to the correct person at the correct time
  • Conversion of paper to electronic format and paper destruction policies
  • Paper and electronic records retention and governance
  • Integration of information using system interfaces and web services
  • Compliance with regulations for electronic records
  • System validation and training to ensure that the system and people do what is expected.

Before considering a technological solution to a problem, consider how the customer will be engaged with the technology and device. Will the customer be delighted with their experience, or will they be frustrated by the lack of efficiency, access hurdles and complicated instructions?

SharePoint 2013 Configuration Guidance for 21 CFR Part 11 Compliance
Michael Agard

Michael Agard

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Michael Agard is a Principal Business Analyst for Paragon’s Life Sciences team engaged in the design implementation and optimization of eTMF and RIM applications. Since joining Paragon in 2010, he has worked with clients on clinical systems architecture and integration, TMF and EDM Reference Models, clinical optimization and document migrations. Prior to Paragon, Michael worked at Sanofi for 28 years. His experience spans Clinical Operations, Data Management, Product Development and Clinical Packaging. Michael holds a Masters in Leadership Development from Penn State, and also has a BS in Pharmacy. He is a member of the DIA and Metrics Champion Consortium.

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