SOURCE: Xtalks

Xtalks Webinars

August 19, 2015 07:00 ET

Best Practice Approaches in Executing Post Approval Programs, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - August 19, 2015) - Join industry expert Alexandra Adams, Late Phase Director at Chiltern, for a one-hour live broadcast on Thursday, September 17, 2015 at 11am EDT / 4pm BST (UK/GMT+1).

Late phase research is increasingly critical to the overall drug development plan. But post-approval studies require different approaches to study execution. Join Alexandra Adams, Ph.D., late phase director, Europe, at Chiltern, as she discusses post-approval programs during a webinar at 11 a.m. EDT on Thursday, Sept. 17. She will demonstrate best practices, review the differences between interventional and non-interventional studies (NIS) and examine the reasons for various operational strategies.

In this session, Adams, who has more than 25 years of experience in both pharma and CROs, will discuss specific case study examples. Participants will:

  • Learn best practices for site selection, including the possible need to over recruit sites for Phase IV trials
  • Gain an understanding of how to expedite the "green light" process given that there will be no investigational product
  • Understand how to work with sponsor affiliates to maximize local engagement.
  • Utilize cloud computing and patient reported data for streamlined data collection and reporting.
  • Select a monitoring strategy that is cost-effective and still quality-centric

Phase IV programs share many of the same requirements of the earlier phases but the methodologies can be quite different. For example, study initiation often occurs at different times as countries gain marketing authorization. For large-scale studies, the scientific rationale is well characterized and broadly published, so there are reduced training requirements; thus, many sites can be easily trained together via interactive Web-based sessions. Sites can be selected for participation with broad mailshots instead of via traditional feasibility questionnaires. Lengthy negotiation of investigator fees can often be entirely negated with a standardized agreement and budget and a take-it-or-leave-it approach. EDC applications are designed with simplicity in mind. And informed consent, still a critical component for late phase research subjects, is generally performed under scaled down templates and SOPs.

"An important consideration for post-approval programs is the type and level of site monitoring required to collect data and maintain quality," said Adams. "Interventional studies still require on-site monitoring, but this may involve reduced source verification, targeted review or a risk-based approach. Non-interventional studies may be monitored entirely remotely or via predefined triggers. The monitoring plan can be significantly less expensive than plans for early phase studies."

Best practices within post-approval research is a wide ranging area and there is much to consider, Adams added. "There certainly can be no one-size-fits-all approach. Each study needs to be reviewed to see which strategies are right for each study."

By the end of this webinar, the audience will have a better appreciation of the uniqueness of post-approval research and will come away with some ideas to apply in their own programs.

To learn more about post-approval research, register for this event or visit Chiltern and see how Chiltern's 34 years of service ensures that it delivers flexible, responsive solutions that are "Designed Around You."

About Chiltern:

Chiltern is a leading global CRO that listens to client needs in order to customize solutions for the biopharma industry. With 34 years in service, Chiltern delivers from three specialized business units: Chiltern Biopharma, with deep therapeutic expertise in respiratory, anti-infectives/vaccines, ophthalmology, dermatology and other specialty areas; Chiltern Oncology, led by physicians, scientists and clinicians to uniquely manage all phases of hematologic and oncologic clinical drug development; and Chiltern Source, a world leader in tailored relationships for FSP, resourcing and staffing solutions. Chiltern's 2,200 engaged professionals work across 45 countries to deliver flexible, responsive solutions that are "Designed Around You."

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About Xtalks

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