Speaker 1: Welcome to Farmer Talk Radio. I'm Andrew Goldstein. In this podcast,
Speaker 1: I'll be joined by raw Lima, SVP of Strategic Clinical
Speaker 1: Operations of Inception Group, about clinical trial rescue. In this conversation,
Speaker 1: we're going to address a scaffolding approach where chief medical
Speaker 1: officers of biotech companies can prioritize the areas that need
Speaker 1: immediate support without sacrificing the entirety of the trial and
Speaker 1: thereby safe time, money and energy rall. Why don't you
Speaker 1: introduce yourself.
Speaker 2: Hi, my name is raw Lima. I'm the executive vice
Speaker 2: president of Clinical Operations for a company called Inception Group.
Speaker 2: I've got about twenty five years of experience in the industry,
Speaker 2: most of that as a VP of clinups for very
Speaker 2: small biotech sponsors.
Speaker 1: To get us started, can you define what you mean
Speaker 1: when you talk about a rescue and what you mean
Speaker 1: when you talk about scaffolding.
Speaker 2: Yeah, I know this one really touched a nerve at
Speaker 2: the CMO conference when we first started talking about it.
Speaker 2: What I'm really getting at with a rescue or when
Speaker 2: people historically and my experience talk about rescues, they're really
Speaker 2: talking about completely changing their vendor, right they're talking about
Speaker 2: ripping their study up, study out from the roots and
Speaker 2: almost starting fresh right. That is very much a nuclear option,
Speaker 2: and that is very expensive, very difficult operationally to pull
Speaker 2: off without tanking the whole study. And so what I'm
Speaker 2: what I'm actually talking about is coming in and rescuing
Speaker 2: a study right doing what is in the word without
Speaker 2: going nuclear and the the or without I'm going to
Speaker 2: use a building analogy and we're going to beat this
Speaker 2: analogy up throughout this whole podcast. You don't have to
Speaker 2: demo the building to build a new building, right the
Speaker 2: way that we refab buildings in New York City and all,
Speaker 2: we're not knocking everything down. We're putting up scaffolding and
Speaker 2: we're repairing it from the insides, and we're targeting what
Speaker 2: needs to be fixed. And so if you use that
Speaker 2: analogy that it really is the what I am talking about.
Speaker 2: It's it's putting some controls around what you do have
Speaker 2: and targeted fixing the things that you might need to fix.
Speaker 2: But what that really comes down to is identifying what
Speaker 2: needs to be fixed rather than focusing on the symptoms,
Speaker 2: which are often bad enrollment. The costs are getting out
Speaker 2: of control. Those are the sorts of things that get
Speaker 2: people to say we need a rescue, but really identifying
Speaker 2: what is the problem and getting to the core issue
Speaker 2: so that you can keep what's good and fix what's
Speaker 2: wrong and support the greater infrastructure that is your study.
Speaker 1: So how can biotechs better identify the root causes of
Speaker 1: these issues so that they're treating those rather than treating
Speaker 1: a symptom.
Speaker 2: This is very much an art form and it is
Speaker 2: the million dollar question, right, But if there are going
Speaker 2: to be problems, they really come down to first you'll
Speaker 2: hear me. Start, there is a fundamental truth to the
Speaker 2: operational reality of your study. So sit down and map
Speaker 2: your study. Who are the vendors, Where is that information
Speaker 2: flowing right, Where does the information get collected, How does
Speaker 2: it flow into a database, How does it flow into
Speaker 2: your clinical database? Who is engaging with the patients? Right?
Speaker 2: So really map your study out so that you understand
Speaker 2: how it works. And when I'm saying this, I'm really
Speaker 2: speaking to the executives, right, the chief medical offices, the CEOs.
Speaker 2: I'm assuming here that you have a clinops team who
Speaker 2: might have already done this, and if you don't, you
Speaker 2: should probably start there. And get one who can help
Speaker 2: you with this. But very often, and I've had this
Speaker 2: experience being a lifelong clinops person, that very often that
Speaker 2: work gets done at the ground level but really doesn't
Speaker 2: get fed up into management in sort of the detail
Speaker 2: that it probably needs to be. Particularly when things are
Speaker 2: going wrong. What you end up getting is opinions of
Speaker 2: what is going wrong rather than sort of really trying
Speaker 2: to identify yourself. But the targets are you know, ultimately
Speaker 2: they come down to a few targets, the sites, right,
Speaker 2: So are the sites able to execute the protocol? Are
Speaker 2: the patients able to execute the protocol? Right?
Speaker 1: Like?
Speaker 2: What is the burden you are putting on? And I
Speaker 2: don't mean theoretical burden in terms of, you know, this
Speaker 2: assessment takes fifteen minutes, this assessed assessment takes thirty minutes,
Speaker 2: But there's an there's a real burden that comes Sometimes
Speaker 2: those assessments aren't done in the same place in a hospital,
Speaker 2: and so if you stack them up, and sometimes if
Speaker 2: you stack them up, it becomes very burdensome. And if
Speaker 2: you stack those things up with timeframes and they are
Speaker 2: done on opposite sides of a hospital campus, that is
Speaker 2: virtually impossible for sites to do, and that will will
Speaker 2: come out in things like protocol deviations. At best. At best,
Speaker 2: people will try and you will get failures. But what
Speaker 2: at worst what you see here is people don't do
Speaker 2: your protocol. They just say it's impossible and they quit
Speaker 2: on you. And so having that discussion, and not just
Speaker 2: with the pis, but with the research nurses, the study coordinators,
Speaker 2: finding ways to touch other parts of the institutions so
Speaker 2: that you really understand what is going on. So that's
Speaker 2: the first is really understand how this is happening at sites.
Speaker 2: The second is, well, who's interacting with those sites and
Speaker 2: who's asking those questions? And very often, particularly small biotechs
Speaker 2: will be very hands off with this. They hire a
Speaker 2: big cro they hire some contractors, and then they get
Speaker 2: hands off because they say it is their job. At
Speaker 2: the end of the day. That might be right, it
Speaker 2: is their job, but it is ultimately your responsibility and
Speaker 2: it is clearly when it goes wrong, your problem. So
Speaker 2: spend some energy there and do it yourself, or get
Speaker 2: very experienced people who you trust, know, maybe have experience with,
Speaker 2: have worked with before, and bring them in. And this
Speaker 2: is what I'm talking about is scaffolding right? You may
Speaker 2: have hired somebody for it, but you don't have to
Speaker 2: fire them and hire somebody new. Maybe just get a
Speaker 2: targeted approach to go do things like talk to your sites.
Speaker 2: Maybe have a targeted approach of having an independent third
Speaker 2: party person come in and talk to both your clinical
Speaker 2: operations group and your vendors and figure out what's going wrong.
Speaker 2: The last piece or the second to last piece that
Speaker 2: could be wrong. Is the vendors themselves right? So is
Speaker 2: their staffing appropriate or do they have the right kinds
Speaker 2: of people doing the work? Have you had a lot
Speaker 2: of turnover? Right? Those are sort of red flag signals.
Speaker 2: And then the last really is in the contract. And
Speaker 2: so I've met again, I've been in experience of this
Speaker 2: where we as biotechs have done it to ourselves, where
Speaker 2: we put out an RFP, it came back, we didn't
Speaker 2: like the price, so we redlined it, and then it
Speaker 2: turns out we needed all of those things, and then
Speaker 2: that shows up later, right, And when that shows up later,
Speaker 2: we tend to be surprised by it, but it's very
Speaker 2: often shouldn't be surprised by it. Really looking at that
Speaker 2: contract upfront, like being honest with yourself about what you
Speaker 2: really do need, and then keeping a documentation of what
Speaker 2: we've readlined so we're not surprised by it in the future.
Speaker 2: Keeping them in things like a risk log are important.
Speaker 2: Way is to sort of mitigate this in the future.
Speaker 2: I'm not saying don't readline. I'm not saying don't try
Speaker 2: to be efficient, but just be honest with yourself. Be
Speaker 2: honest with your future self about some of the compromises
Speaker 2: you might have made, because it does make it easier
Speaker 2: to reckon with them and identify what those problems might
Speaker 2: be if you have a strong record of it. And
Speaker 2: today it's never too late to do that activity. And
Speaker 2: so if your contract was written poorly two years ago,
Speaker 2: or maybe you're a new team on a failing study
Speaker 2: and you're trying to make that decision, today is a
Speaker 2: great day to start looking in the mirror and being
Speaker 2: honest about the contracts you have in front of you
Speaker 2: and what they do and do not include, and trying
Speaker 2: to reckon with that all at once, because it is
Speaker 2: very painful to do it incrementally. That that is painful
Speaker 2: for the vendors, and it is painful for the sites.
Speaker 2: It is painful for the overall study. So getting at
Speaker 2: the sites, vendors, contracts are really the three and the
Speaker 2: last pillar, if we're going to beat the house metaphor,
Speaker 2: the last pillar is the protocol itself, right, So the protocol,
Speaker 2: the sites, the vendors themselves, and the contracts.
Speaker 1: So I understand the contracts, and I understand the protocol.
Speaker 1: But you know, when you're talking about site burden, or
Speaker 1: you're talking about vendors who aren't educating off actively, or
Speaker 1: don't have the right staffing or have turnover, you know,
Speaker 1: why is the answer scaffolding rather than you know, a
Speaker 1: rescue and going to a different group to work.
Speaker 2: With that the ultimate answer might be going to a
Speaker 2: different group. What you want to be able to do, though,
Speaker 2: is a soft landing, right, And so cutting across into
Speaker 2: a new organization that has all sorts of new rules
Speaker 2: and a new way of working might be a similar
Speaker 2: shock to the system as before. So what I'm actually
Speaker 2: recommending is putting up scaffolding to make sure you're solving
Speaker 2: the right problem. Because, for example, if the problem is
Speaker 2: the protocol, but you think that it is the staff,
Speaker 2: and you go and you fire your cro and then
Speaker 2: you hire a new one that is a very costly
Speaker 2: and painful activity that ultimately won't get you anything because
Speaker 2: your actual real problem was the burden on the sites
Speaker 2: from protocol assessments. And then the new CRO is going
Speaker 2: to come in and have very similar challenges and you
Speaker 2: might have very similar outcomes, and so if you're not
Speaker 2: identifying the right problem, then you can't actually solve for it.
Speaker 2: And sometimes what you have with for example, staffing issues,
Speaker 2: Let's say with cras, this is a very common one
Speaker 2: where you know a lot of the cras out in
Speaker 2: the field, particularly with larger organizations, don't have as much
Speaker 2: experience the company. Those companies are built for scale and
Speaker 2: they have some lesser experience staff, and if the issue
Speaker 2: is with those, then finding ways to support those just
Speaker 2: firing those staff and putting a new inexperienced staff, you
Speaker 2: might not get the kinds of people you want with
Speaker 2: the next one, and you're going to have to train
Speaker 2: that new person, and so you could get into this
Speaker 2: cycle of finding where what you really need is somebody
Speaker 2: to do some oversight and education of those people which
Speaker 2: may or may not exist inside of that CRO right
Speaker 2: because the CRO is never going to be an expert
Speaker 2: at your clinical trial. They're never going to be an
Speaker 2: expert at sort of the intricacies of your assessments and
Speaker 2: the way you want things done. They're just not right.
Speaker 2: They're not living your trials every day. Some of the
Speaker 2: boutique CROs do and engage differently, but the bigger ones don't.
Speaker 2: Like they're there to check boxes and to do source
Speaker 2: stark verification and collect documents, right, They're not really there
Speaker 2: to live your study. And so have somebody there to
Speaker 2: live your study and to help them through their day,
Speaker 2: help them be more efficient. And that's a real value
Speaker 2: add that you can put inside of your organization who
Speaker 2: can go across your programs or across all of your
Speaker 2: sites and across all of your vendors to create that consistency.
Speaker 2: And that really does look like your clinops group. But
Speaker 2: again people don't think of it this way. They think
Speaker 2: of that as extra staff that you don't need and
Speaker 2: that you can redline. But that is a function. If
Speaker 2: you separate everything into its little component pieces, then if
Speaker 2: there really is nobody to tie it all together, then
Speaker 2: what you often get is disassociated pieces. And it's not
Speaker 2: that those pieces are wrong, they're not coming together the
Speaker 2: way you want, and that often is what I'm talking
Speaker 2: about with scaffolding, Like, don't fire the people at the
Speaker 2: bottom who are making the pieces and get new people
Speaker 2: to make pieces, because they're just going to make those pieces.
Speaker 2: You need something different.
Speaker 1: So how can companies implement scaffolding effectively?
Speaker 2: You know, there's a lot of ways to go about this.
Speaker 2: Some have an instinct to go internal, right, so just
Speaker 2: to hire some extra people internally to oversee those activities.
Speaker 2: What I would say to most CEOs and CFOs cmos
Speaker 2: out there is that clinops is a very very difficult job.
Speaker 2: That is, you know, forty percent skill and like sixty
Speaker 2: percent solving problems right that come up emergently, and the
Speaker 2: more skilled people are prepared for those emergent problems. In
Speaker 2: order to do this well, you need somebody who's seen
Speaker 2: those problems before, who are prepared in have backup plans.
Speaker 2: It is a very hard job. Don't under resource it internally, right,
Speaker 2: Let's start there. Don't underresource it internally. There is a
Speaker 2: lot of information, there's a lot of data to look at.
Speaker 2: There's a lot that can go wrong, and when those
Speaker 2: things go wrong, you're already like two months too late
Speaker 2: to solve them. And so you really need people there
Speaker 2: living and understanding it in order to engage it well.
Speaker 2: So everybody wants to keep it into a tight internal staff.
Speaker 2: Just have some slack in your systems so that you
Speaker 2: can handle what I call the unexpected, the expected unexpected problems. Right,
Speaker 2: things are going to go wrong, make sure you have
Speaker 2: slack in the system to cover that. Also, make sure
Speaker 2: you have people who can talk at multiple levels to vendors. Right,
Speaker 2: So very often we biotechs are built with very very
Speaker 2: high level people in mind, and they have high science
Speaker 2: and high technology at their forefront. But if you if
Speaker 2: you skip down a few levels, the people who are
Speaker 2: cras don't necessarily have that same sort of skill set, right,
Speaker 2: They're just there's they're not going to have that skill
Speaker 2: set because their job is to be broad bridging the
Speaker 2: gap to understanding sort of what is coming up from
Speaker 2: the field, like the complaints and the difficulties, and then
Speaker 2: what the science is saying and how to implement that.
Speaker 2: You need people who can bridge that gap and so
Speaker 2: really focus on that. Those sorts of i'll call translation
Speaker 2: skill sets. It's not translations of language, it's translation of
Speaker 2: jargon that that you really you really need, and so
Speaker 2: you can find this potentially through consultants, through boutique CROs,
Speaker 2: through through internal hiring with the right sort of skill
Speaker 2: set approach, right, but be really mindful that you have
Speaker 2: different people with different levels of skill that all need
Speaker 2: to be communicated and messaged to, and that in and
Speaker 2: of itself is a skill set. I'd also say this
Speaker 2: on this point that as technology has become more and
Speaker 2: more infused into what we do, many of people, many
Speaker 2: of the people who deliver that technology are technology companies,
Speaker 2: not clinical companies, and so you really need somebody to
Speaker 2: do And I'm not talking data management in the classic
Speaker 2: sense i am I'm literally here talking about programming in
Speaker 2: IT and back end data in you know, architecture. You
Speaker 2: really need somebody who can speak that language as well,
Speaker 2: because you know, nowadays it is very common to have four, five, six,
Speaker 2: maybe even up to ten different data sets feeding your
Speaker 2: final analyzable data set. Getting all that information to be
Speaker 2: brought in and talk to each other is actually extraordinarily complex,
Speaker 2: and you really should have somebody dedicated to speaking that language,
Speaker 2: because if you don't, you will have problems tying the
Speaker 2: information together, and that is very hard to unwind. Once
Speaker 2: it is built right, it's a lot easier to build
Speaker 2: it right. Kind of add on to it, do transfers.
Speaker 2: If you build it wrong and the transfers don't work,
Speaker 2: that can be very painful and that often doesn't show
Speaker 2: itself until you are trying to get data out and
Speaker 2: it becomes a crisis. So really really focus on these
Speaker 2: points of translation, and don't underestimate both that they exist
Speaker 2: and that they are getting more and more complicated as
Speaker 2: the as sort of our industry fragments.
Speaker 1: Seems like you're looking for unicorn here who can speak
Speaker 1: the technology, you can speak broad and speak the jargon.
Speaker 1: How do you find these people?
Speaker 2: Well, I guess that's my sort of point is that
Speaker 2: it might not be It might not be a single person,
Speaker 2: and don't underestimate that it might need to be multiple people.
Speaker 2: And I get for small companies that that that may
Speaker 2: be difficult. But that's where I'm saying, borrow this from
Speaker 2: boutique CROs or from consulting companies. Get your one or
Speaker 2: two good clinops, people who know enough to kind of
Speaker 2: put their tendrils in and to really help to help
Speaker 2: you as an organization speak the language. But then borrow
Speaker 2: some independent experience from just bringing in your vendors, right
Speaker 2: because they might ask questions that you don't really understand,
Speaker 2: but you might think you understand, and that's where you
Speaker 2: go wrong. So just borrow that and make sure you
Speaker 2: have sort of solutions for checking your instinct and then
Speaker 2: if something does go wrong, borrow more of it. And
Speaker 2: that's the scaffolding approach, right like early on, try to
Speaker 2: infuse this into the way you build your program. But
Speaker 2: if it goes wrong and you're at a rescue and
Speaker 2: you need to scaffold, then go out and find independent
Speaker 2: people who are good at this particular problem that you
Speaker 2: need to solve, or the set of problems that you
Speaker 2: might need solve, and go and engage with that and
Speaker 2: start with fact finding and then move yourself up. As
Speaker 2: we talked about early on, Andrew, the answer might be fire.
Speaker 2: You know, the ultimate answer might be fire your cro
Speaker 2: and demo and rebuild. I'm not saying it doesn't happen,
Speaker 2: but I'm saying that it should be a process to
Speaker 2: get you there. That's where scaffolding can help.
Speaker 1: So to drill down a little bit, you know, if
Speaker 1: you're going to need to bring another vendor in any
Speaker 1: way you know are there time and cost savings is
Speaker 1: that you know you don't want to end up in
Speaker 1: a situation where you're firing all your cras and hiring
Speaker 1: a new batch of cras who and you're going to
Speaker 1: end up in the same situation, or you know where,
Speaker 1: where are the time and cost savings for switching the approach?
Speaker 2: The goal is to identify your problems and target them
Speaker 2: so that you are not just blowing everything up, and
Speaker 2: so you're walking your way there smartly, right, like we
Speaker 2: are not demoing the building because we wanted to change
Speaker 2: an electrical plug. The time and cost savings come from
Speaker 2: not actually demoing the whole thing and so incrementally walking
Speaker 2: your way to solving the problem, to the solving the
Speaker 2: problems in front of you and making sure that you're
Speaker 2: solving the right problem is the smart way to go
Speaker 2: about it. Right. It goes slow to be smart, but
Speaker 2: being smart goes fast. Right. It's that sort of mindset,
Speaker 2: right like you might feel that that need to go
Speaker 2: do something, break something, and keep moving, But often what
Speaker 2: that does is it is it compounds the complexity and
Speaker 2: compounds the problems and makes it very difficult to continue
Speaker 2: to operate long term, right, and you don't want to
Speaker 2: tank everything and so identify and I would say, if
Speaker 2: you are are held bent on actually changing over your CRO,
Speaker 2: it does actually make sense to overlap your new CRO
Speaker 2: and your old CRO, and you might want to do
Speaker 2: that in a staged approach, right, So bring in your
Speaker 2: new CRO's project manager and maybe CRA manager at first
Speaker 2: to really get a sense right and engage them as
Speaker 2: internal consultants and let them get a feel for the
Speaker 2: study and what they're going to need and make sure
Speaker 2: they really understand it before you pull the trigger and
Speaker 2: change everything that the sites see. So you might end up,
Speaker 2: like I said, you might end up in those same places.
Speaker 2: It might cost you more in the short run, But
Speaker 2: the goal is to smooth out the operations, make things
Speaker 2: mean for your customers, and make make things organized on
Speaker 2: the back end right, so you don't have sheer chaos everywhere.
Speaker 1: So at the cmosumm it this past year, Ken gets
Speaker 1: brought up and I think he's brought this up in
Speaker 1: years prior as well, that we're seeing more and more
Speaker 1: protocol amendments happening, which add more money to trials and
Speaker 1: add more time to trials and earlier in our conversation,
Speaker 1: you spoke about expected unexpected? Are these inevitable? Are these
Speaker 1: rescues in scaffiolding approaches inevitable based on the way that
Speaker 1: we currently run clinical trials? You know, he's there that
Speaker 1: we could be doing from the beginning so that we
Speaker 1: don't have to do an amendment, so that we don't
Speaker 1: have to, you know, hire another group to watch over everything,
Speaker 1: or hire another internal person to watch over everything.
Speaker 2: I don't have this data, but I'm gonna I do
Speaker 2: believe that some of these amendments are inevitable because what's
Speaker 2: driving particularly for biotechs, right, biotech aren't really in the
Speaker 2: phase three space. They're in the phase one phase two
Speaker 2: space largely, right. Some do move on, but by the
Speaker 2: time they move there, they themselves become more mature, their
Speaker 2: programs become more mature. So really what drives a lot
Speaker 2: of these amendments early on is phase one and phase
Speaker 2: two research. And I think it has gotten worse over
Speaker 2: time because the medicines we are doing don't have clean
Speaker 2: and clear regulatory pathways. Right, we actually don't know what
Speaker 2: the answers are, and we don't really know what we
Speaker 2: are doing, and we're using phase one in phase two
Speaker 2: to learn and I don't mean this in a bad way.
Speaker 2: That is good science. That is exactly the way science
Speaker 2: is supposed to work. It's that the propulsion of these
Speaker 2: personalized medicines out of pre clinical and into human it
Speaker 2: goes a lot faster than in the with small molecules.
Speaker 2: And so what you're seeing is we're sort of learning
Speaker 2: on the job, right and we're learning with diseases that
Speaker 2: aren't well studied in academia, right, Like they don't have
Speaker 2: big data sets, so we don't know the answers. And
Speaker 2: so I do think that we have to expect that
Speaker 2: some amount of amending the protocol, some amount of what
Speaker 2: we think is good science, hits the wall of practicality.
Speaker 2: That's the site the protocol or site issue where it
Speaker 2: seems like it's a good idea to do this thing
Speaker 2: and then send them to do a scale and then
Speaker 2: send them to an MRI. But those two things happen
Speaker 2: in vastly different places inside of the inside of the institution.
Speaker 2: So if you're really trying to do them at the
Speaker 2: same time, that takes inordinate amount of infrastructure for an
Speaker 2: institution and might not be possible in some institutions, and
Speaker 2: so those sorts of things that we could do in
Speaker 2: one site or two sites, but then as soon as
Speaker 2: we try to scale up even to five or eight
Speaker 2: sites start to become improbable, if not impossible. We have
Speaker 2: to amend the protocols, right, and we have to amend
Speaker 2: the way we engage with the science and we engage
Speaker 2: with the operations, and so those things are inevitable. I
Speaker 2: would say, I would say this, start by building it in.
Speaker 2: If we know that this is true one big failure,
Speaker 2: that maybe it's a failure, maybe it's a reality of
Speaker 2: the financial constraints of a company. Right that start by
Speaker 2: building it in. We expect that there's going to like
Speaker 2: expect that there's going to be two or three amendments,
Speaker 2: and then suddenly you're not surprised by having two or
Speaker 2: three or four amendments. Right, The financial hit is less.
Speaker 2: And so if you if you build knowing what happens
Speaker 2: in the real world, then these become less of a shock.
Speaker 2: I think where they become a problem is where we
Speaker 2: think we know the answers, we try to engage with it,
Speaker 2: or we read line contracts, we readline protocols right and
Speaker 2: say no, no, no, this has to be in. This has
Speaker 2: to be in, and then they become unenrollable or the
Speaker 2: budgets are way you off, and then those things start
Speaker 2: to impact operations and then what managed, Like I said,
Speaker 2: management has the symptom problem right, well, the board doesn't
Speaker 2: like what is happening from a budget standpoint or an
Speaker 2: enrollment standpoint. We've got to change things. We've got to
Speaker 2: rescue this trial. And you'll hear people start talking about
Speaker 2: rescues or you know, we're not getting what we want.
Speaker 2: And then again you really have to identify why. And
Speaker 2: sometimes you did it to yourself, and sometimes it's the protocol,
Speaker 2: and sometimes the vendors doing it to you. But if
Speaker 2: you solve the wrong problem, then you're just going to
Speaker 2: be five more months delayed.
Speaker 1: Anything else that we didn't touch that you wanted to
Speaker 1: share with the with the audience.
Speaker 2: My goal here is to really get people to be
Speaker 2: thinking about operations as a strategic partner rather than just
Speaker 2: a delivery partner. Bringing operations into the room where you're
Speaker 2: planning the science and planning the logistics and whiteboarding and
Speaker 2: nap getting a protocol all is a valuable project. It
Speaker 2: is a valuable prospect if you have the right person
Speaker 2: doing that, a high enough level operations person coming in
Speaker 2: to do that. And then even once that is done
Speaker 2: and you have a cro and you have a group,
Speaker 2: what I would what I would say is, you know,
Speaker 2: listen to your listen to your consultants, and listen to
Speaker 2: the people who might not be science oriented, right so
Speaker 2: you know, get your program protocols in front of study coordinators.
Speaker 2: Really go and engage with those sorts of people because
Speaker 2: they're going to have a perspective that you you might
Speaker 2: not otherwise appreciate. And if you can cut that off early,
Speaker 2: then you know you're doing better planning. Right. It's it's
Speaker 2: the same way that the industry has made a big
Speaker 2: push to bring in patient voices. We think about our
Speaker 2: patients as the ultimate customer of the drugs, which is true,
Speaker 2: but the ultimate customer of pro calls is sites. And
Speaker 2: you should really be thinking about the people who are
Speaker 2: executing the trial at the site level and infusing their
Speaker 2: voice as well about what is and is not doable.
Speaker 2: Don't just listen to the pis. The pis the pis
Speaker 2: overview everything, and the pis know the science and they
Speaker 2: have a particular lens. Go talk to the nurses and
Speaker 2: go talk to the you know, drug infuses or the
Speaker 2: technicians ultrasound and MRI. You got to go talk to
Speaker 2: them and find out what is and is not possible.
Speaker 2: And you know there is a fundamental truth. So the
Speaker 2: earlier you find it out, the better you're planning is
Speaker 2: going to be. Don't stick your head in the sands
Speaker 2: and really think about operations strategically, both at the beginning
Speaker 2: and when you're thinking about rescue like infuse that back in.
Speaker 1: Thank you so much for your advice and expertise in
Speaker 1: the clinical operation space and for talking about scaffolding and
Speaker 1: rescuing and how we can better approach different issues that
Speaker 1: may come up in the clinical trial space. But where
Speaker 1: can people learn more? Connect with you.
Speaker 2: If you wanted to reach out to me. I'm sure
Speaker 2: my information will be connected in this website. But I
Speaker 2: work for a company called Inception Group, and we are
Speaker 2: an outsourcing partner and we engage mostly with very very
Speaker 2: small biotechs, and so I know I've done a lot
Speaker 2: of this for small biotechs, So you know, just reach
Speaker 2: out to me personally or Inception Group and we can
Speaker 2: go from there.
Speaker 1: Thank you so so much again and looking forward to
Speaker 1: speaking to you again soon. I hope you enjoyed the
Speaker 1: podcast you are listening to raw lima SVP of Strategic
Speaker 1: Clinical Operations at Inception Group, about new approaches the clinical
Speaker 1: trial rescue that can save time, money, and energy by
Speaker 1: better anticipating potential challenges and identifying root causes. For more
Speaker 1: information about Inception Group and their clinical operations and project
Speaker 1: management services, please visit Inceptiongroup dot com. For more information
Speaker 1: about the Chief Medical Officer Summer three sixty editorials, podcasts,
Speaker 1: or webcasts, please visit CMO three sixty dot org