Name: Navigating data management strategies
Uploaded: 2023-08-09T06:31:18.593Z
Duration: 349.87

Brett 2nd Edited.mp4

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Um, but yes, definitely part

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of protocol development.

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You should have a good data

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manager, have a look at that

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in terms of the schedule.

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And also they pick up a

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lot of errors in scheduling

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and things like that that

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won't work at sites and.

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Thank you for

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joining us, Helen.

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Helen is one of our

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longest partners with

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the Lithia Life Sciences.

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She's managing director and

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founder, I should say, of

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PureCDM a company that we have

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known for and worked with.

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Nearly 20 years oh, I should

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say Helen, we've worked with

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nearly 20 years, but,  what I

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wanted to talk to Helen today

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was the importance of when you

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are building a strategy for

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your product, the importance

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of data management, because

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I know I always say that

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the data becomes your asset.

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So, Helen, welcome.

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Thank you, Tina.

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And what I wanted to also

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ask you was, when is a

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good time for someone to

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start engaging with a data

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management professional.

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As early as possible

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Tina, I really think even

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before you write your

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first protocol having a

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data governance strategy

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built into your portfolio.

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It's really important

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but yes, definitely part

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of protocol development.

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You should have a, a, a good

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data manager, have a look at

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that in terms of the schedule.

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And also they pick

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up a lot of errors.

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In scheduling and things like

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that that won't work at sites

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and I know in our experience,

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we, we do routinely use

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your group when we have a

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really good draft of the

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protocol, we send it to you

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and your team for exactly

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that cause you have the

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depth of experience and you

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look at it not really just.

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Purely design or regulatory

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perspective, but from a

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practical and pragmatic,

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even in terms of when

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you're going to time the

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assessments, how often the

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assessments are done, and

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what impact they might have

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on other aspects of the study.

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And do they make sense?

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And do they even make sense?

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Because everything, when

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we write a protocol, it's

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in the idealistic world.

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Right.

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But not necessarily means it

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can be in a practical sense.

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Exactly.

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So the sooner the better it

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saves potential amendments to

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the protocol, which everyone

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knows, costs, companies money.

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Yeah.

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And time having to.

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And time.

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Yes.

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Yeah.

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And I was also going to

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ask you, one of the lovely

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things that we enjoy about

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working with your company

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very closely is that you are

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generally agnostic to the

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data management the EDC system

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that you use and that's really

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a differentiator between

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your company and the others.

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Can you tell us a

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little bit of how that

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came about, please?

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Certainly is Tina.

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Yeah, so, we strongly believe

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that there isn't a one size

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fits all approach when it

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comes to managing clinical

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data and as we all know,

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EDC systems are a vessel, a

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technology vessel, but the

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customization and price point

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really is customer centric.

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So it really needs

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to be tailored.

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A tailored approach and

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you really need the, you

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know, good experts to

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know how all of these

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different systems work.

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They all have you know,

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they're pros and cons and,

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and you have to pick a system

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that's fit for purpose.

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So if you've got a phase

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one healthy volunteer trial,

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you know, you don't need

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a super expensive, Rolls

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Royce Station, EDC system.

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Yeah.

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You know, you can use.

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A validated system that's

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made that doesn't have all

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the bells and whistles and

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maybe is a little bit more

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cost effective for the client.

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Whereas if you're running a

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big global phase two or three

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study, you've gotta look at

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what your, you know, where

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the sites are, what they're

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used to using, and whether

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the system is flexible enough

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to handle a complex study.

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Thank you.

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And I think the take home

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message for me is, and in my

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experience is that it's all

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about the client and when we

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approach a client to do, you

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know, to provide a proposal

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and if that client were to

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have an e d C system that

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they worked with before and

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they could be happy with, the

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chances are that Helen's group

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can also adapt and use that

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trial for that, the particular

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project that would work with

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the Lithia and PureCDM on?

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That's correct.

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Yeah.

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The other thing I was going to

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talk to you about was that we

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have a philosophy that we work

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very collaboratively in as a

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team at Lithia Life Sciences.

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So we would bring in Helen's

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group right from the start.

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So we would have an internal

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kickoff meeting and then an

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external kickoff meeting.

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And so everybody is

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transparent in terms of

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what's happening because

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it's really powerful.

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It's always good to have

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different sets of eyes,

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and, fresh, view on what's

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going on with the project.

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So do you Absolutely,

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totally agree.

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And I think the, you know,

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the focus of the project

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team that's brought together,

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it's multidisciplinary and

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it's all about delivering

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a project for the client.

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So, there's no egos.

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They're all left at the

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door and it's really putting

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our heads together and

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thinking about what's the

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best strategy to get to the

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next step without delay.

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How to streamline.

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Cost effective and

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time effective.

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Effective, exactly.

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Yeah.

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Okay.

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Well thank you very much

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Helen, and I hope that's

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been really helpful when

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you consider lithium and

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PureCDM for your next project.

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Thank you.

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Thank you.

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Thank you.

Expert Insight

In this interview, Helen, the Managing Director and Founder of Pure CDMA, shares her expertise on data management strategy with Tina from Lithia Life Sciences. They discuss the significance of data management in protocol development, the importance of early engagement with data management professionals, and the flexibility of EDC systems. 

The conversation highlights the collaborative approach to project success and offers valuable insights for anyone involved in clinical trials and research. 

Join us to learn from two decades of experience in the field.

Bio Connections

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A/Prof Tina Soulis

Founder & Director

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Helen Poliviou

 Managing Director 

Optimal timing for engaging data management professionals

Balancing idealism and practicality in protocol writing

Flexible approach to EDC systems

Client-Centric focus

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Navigating data management strategies

Funding, Policy & Reform