What We Learned from the Clin Ops Nightmares of 2020 with Kunal Sampat of Ceribell
11/17/20 • 30 min
Episode Highlights:
- Why it’s vital to adapt—during the pandemic and always.
- Why clarity around workflow is critical to adaptation.
- What sponsors and CROs can do to reduce the burden on their sites, and why it’s their responsibility.
- How “making the sites our heroes” can help with patient recruitment.
- The importance of creating ways for your sites to exchange information with each other.
- How the CRA role is evolving.
- How tech vendors can address the biggest obstacle to adoption.
- Why video is the best tool for training and communication, and how to leverage it.
- What the future of effective clinical operations will look like.
- Kunal’s favorite resources for staying up-to-date.
Resources you need to check out:
www.fda.gov/industry/fda-basics-industry/guidances
Episode Highlights:
- Why it’s vital to adapt—during the pandemic and always.
- Why clarity around workflow is critical to adaptation.
- What sponsors and CROs can do to reduce the burden on their sites, and why it’s their responsibility.
- How “making the sites our heroes” can help with patient recruitment.
- The importance of creating ways for your sites to exchange information with each other.
- How the CRA role is evolving.
- How tech vendors can address the biggest obstacle to adoption.
- Why video is the best tool for training and communication, and how to leverage it.
- What the future of effective clinical operations will look like.
- Kunal’s favorite resources for staying up-to-date.
Resources you need to check out:
www.fda.gov/industry/fda-basics-industry/guidances
Previous Episode
Welcome to Conversations in Clinical Trial Readiness
Welcome to Conversations in Clinical Trial Readiness, a series featuring life science executives who share their stories and insights related to clinical operations and clinical trial readiness.
Listen in to hear how health and life science organizations can better equip teams and clinicians to accelerate the development and adoption of new clinical treatments and best practices.
Learn from our experts as they share their key learnings, obstacles, and success stories.
Join us as we talk to clinical trial executives from different corners of the industry.
Next Episode
Demystifying Decentralized Clinical Trials with R'Kes Starling
Episode Highlights:
- The industry and operational challenges facing DCT adoption.
- How inconsistent nomenclature has contributed to widespread misunderstanding of DCT, and how misnomers have slowed adoption.
- The challenge of change management and how clarity and infrastructure can be an antidote.
- How DCT can help boost minority representation in clinical trial research, and why shifting those numbers requires time.
- How sponsors can get started with DCT and what they need to consider.
- Why organizational fit is critical and how to assess it.
- Why it’s so important to talk with the patients and understand the challenges they face.
- Why DCT and patient-centric approaches so often go hand-in-hand.
- How patient engagement is changing, and why clinical trials need to adapt to that.
- How sites have been forgotten as stakeholders and why they’re still central to clinical development.
Resources:
- www.archemedx.com
- Conversations in Clinical Trial Readiness series
- www.revelesclinical.com
- www.linkedin.com/in/klritch
- www.linkedin.com/in/r-kes-starling-rph-mba-9996214/
- www.clinicaltrialpodcast.com
- Reveles’ Decentralized Clinical Trial Grader: https://form.typeform.com/to/RhOpipVQ
- https://www.linkedin.com/company/reveles-clinical-services
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