Typical Challenges in Outsourcing and How to Overcome Them

Typical Challenges in Outsourcing and How to Overcome Them

[00:00:00] Alexander: Welcome to another episode of the effective statistician. And today it’s again with. Benjamin and [00:00:10] myself. Hi, how are you doing? 

[00:00:12] Benjamin: Good. Very well. How are you? 

[00:00:14] Alexander: Very good. It’s Monday morning and I’m pretty excited [00:00:20] as we are recording this.

[00:00:22] Benjamin: Yeah, it is a really nice, nice topic. So some experience we can share.

[00:00:26] Alexander: Yep. Yeah. Yeah. Outsourcing [00:00:30] Well, I guess there’s hardly any sponsors that works without outsourcing. Yeah, everybody can work with vendors all the time. [00:00:40] And there are, of course, several ways You can outsource stuff. One is what I would call actually more kind of [00:00:50] in-sourcing. If you basically hire people from another company to work within your systems, according to your [00:01:00] SOPs and basically some, something like augmented teams. Yeah. 

[00:01:05] Benjamin: That kind of FSP or what you call it. 

[00:01:07] Alexander: Functional service providers very, very [00:01:10] often support for this. And then you need to have the right people in the right jobs. [00:01:20] That’s something we don’t want to cover today. What we want to cover today is what I would say is project based outsourcing. So is that the [00:01:30] right term?

[00:01:30] Benjamin: Project based. I mean, that is, that is kind of the department that we call ourself, but it actually, it is based on unit based outsourcing. So you kind of, [00:01:40] you know, work on a, You know, have a, have a list of items that need to be covered in a way, like an SAP writing or delivery of outputs. [00:01:50] And you kind of think about the whole outsourcing in types of units. Sometimes it is combined with. [00:02:00] Time and material, what we call time and material. So additional items to be covered based on an hour, like on a time that you need for it, [00:02:10] but that is something, you know, what is usually also covered from consulting type of roles where you have a [00:02:20] dedicated people that support.

[00:02:22] Benjamin: Upon requests like on a time and material basis on a, on a way, you know, being charged, not based [00:02:30] on a unit, but based on an hour. Yeah. 

[00:02:32] Alexander: I guess there’s, there’s lots of different variations for it. And [00:02:40] today we want to talk about the different challenges within that. And, well, Benjamin has [00:02:50] Decades of experience working on the CRO side, I have worked a lot on the sponsor side and also a little bit on the CRO [00:03:00] side.

[00:03:00] Alexander: And so I’m pretty sure this will be an interesting and insightful discussion. So when we, you know, [00:03:10] Dipped into this conversation a little bit earlier before we hit record was pretty clear that one of the biggest, [00:03:20] the biggest challenge very often lies just within communication. And well, communication is of course a very, very [00:03:30] broad topic and there’s lots of things we are communication.

[00:03:35] Alexander: Can go south. So what is the first thing that comes to [00:03:40] mind when, when you think about challenges within communications?

[00:03:44] Benjamin: Many things. No, I mean, communication is a white, as I said, it’s an [00:03:50] extremely white field. So it’s not, there are different types of communication. And one thing that is usually coming up quite, quite quickly is that, that [00:04:00] There’s, there’s often a misunderstanding of, even though we are talking about the same thing, it’s a misunderstanding of how to interpret it or how to, how to read this, how to, how to work [00:04:10] with it.

[00:04:10] Benjamin: And my classical example is, is for example, like when we talk about timelines or database lock for database lock. And for some people, so if you talk to clinical people, [00:04:20] database lock means actually it’s the last day or last time point when you can actually Enter a change data. So why, when you talk to a statistician, database log and [00:04:30] timelines for statistician, database log is usually, you know, the, you know, the clock starts counting when actually you receive the data.

[00:04:37] Benjamin: So it’s actually at the other end of the database [00:04:40] log, but, but when you talk about, oh, we have, you know, we talk about timelines and you have you know, you have, you say it’s two weeks after database log for [00:04:50] the one it’s actually. Two weeks after, you know, the last data has been entered and changed, like the query has been answered.

[00:04:57] Benjamin: And for the others, two weeks, you know, after [00:05:00] you received the data and this, there could be like a gap of actually two weeks between one or the other. So that is, that is something where I, you know, what’s, what is [00:05:10] one of my most you know, the experience I have seen quite often is that we are talking about the same thing, but actually it’s a little bit different.

[00:05:18] Benjamin: a perception of [00:05:20] what, what it means. So yeah, 

[00:05:22] Alexander: I, I’ve seen that as well, even when it comes to, so timelines and milestones as one thing, the other [00:05:30] thing is also these different units. Yeah. So what is a unique table? What is a repeat table? Even what is a listing? Yeah. These things [00:05:40] can vary quite a lot from organization to organization.

[00:05:45] Alexander: And just because you have an understanding of some things [00:05:50] that is not necessarily the same like the business partner you’re working with. 

[00:05:56] Benjamin: No, that’s, that is exactly. So that is, that is one of the, you know, that’s [00:06:00] coming first in my mind, but actually it starts to my understanding, it starts a little bit earlier.

[00:06:04] Benjamin: So it’s kind of, you know, it’s kind of communication [00:06:10] sometimes it’s kind of some, political way as well is that, that you are not, you know, when you’re, when you outsource. So I would, I would expect like [00:06:20] full transparency. So I would expect that this is, you know, outsourcing is not, Oh, he take it and just do it and then leave me alone and give it back when you’re done.

[00:06:29] Benjamin: But [00:06:30] outsourcing usually like should be kind of you know, like a prolonged of interaction I got to, to, to the company that, that, you know, you are, you’re supporting. [00:06:40] So that means that if you, if you’re really want to fulfill the role of, you know, like a complete outsource, like partially [00:06:50] outsourcing, but really do this, you know, with the, you know, within the expectation.

[00:06:55] Benjamin: Of, you know, of the person of the company that is out, actually outsourcing, you need [00:07:00] transparency, you need, you need to have, have an understanding of what actually is the goal of this piece of like a [00:07:10] project that you’re doing on the one side. Also, you have to have transparency about expected timelines and.

[00:07:18] Benjamin: And I like [00:07:20] an interaction. Also, what is the, the planning beyond, beyond that in, in, in terms of timelines, so that you kind of have the opportunity to give your [00:07:30] expertise. To the, you know, to, to the best solution. Yeah. 

[00:07:35] Alexander: I love the idea that you first start with what’s the goal. [00:07:40] Yeah. So why actually are we doing the study?

[00:07:44] Alexander: Yeah. Why do we need these analysis? What [00:07:50] is the purpose of this table? Yeah. If you don’t provide that as a sponsor, it will be [00:08:00] very, very difficult to come up with a great product. Yeah. If you don’t understand the backgrounds, you will not be able to understand [00:08:10] What is maybe wrong in the data? Maybe, you know, just, you know, with specifications, you can be always, you know, [00:08:20] a lot of detail.

[00:08:23] Alexander: Still, there will be always uncertainties, you know, and if you don’t provide background, [00:08:30] people will not. understand it. Yeah. So as an example, I was once working on ADHD. Yeah. [00:08:40] Very simple. In most ADHD studies, there are far more boys than girls. Yeah, and there was a coding issue in [00:08:50] the database. And then when we got the tables back, there were far more girls than boys, which was kind of [00:09:00] unexpected.

[00:09:00] Alexander: Yeah. As a sponsor, I should have better trained the people in terms of what is the [00:09:10] disease area? What are the scales? Which scales do we expect to go up? Which scales do we expect to go down? What are all the kind of [00:09:20] typical things, yeah? That would have prevented the programmers from delivering such a table.

[00:09:27] Alexander: Yeah, where there’s obviously something wrong in [00:09:30] it. But of course you need to have some insights into that. 

[00:09:34] Benjamin: Yeah. And also, I mean, the, one of the purpose for outsourcing, I mean, obviously it’s, you know, [00:09:40] the overall goal is usually that, that, you know, it’s, it’s cheaper. So it’s kind of a money saving exercise, but also it, it should save [00:09:50] time for yourself, for the sponsor.

[00:09:52] Benjamin: So it’s actually a time You know, it, it frees you up to do other things, but how, how do you do this efficiently? I mean, this is not, you know, [00:10:00] if you, if you don’t, if you, if you’re not open with the communication, with the plan, with the timelines and, you know, interactive and helping everyone to understand and be [00:10:10] part of the whole team, this is all left to you.

[00:10:14] Benjamin: Right. So it is your time that you will be actually do a redoing the work and rechecking [00:10:20] and re, re, re, whatever. Right. So it is, it is not, not a help. And it’s not satisfying for either side, actually, if if you end [00:10:30] up, you know, being unsatisfied because the quality isn’t good, but actually, I mean, okay, so if the quality, if there are errors, okay, that’s one thing, but actually if, [00:10:40] if the purpose is not met, right?

[00:10:42] Benjamin: So if you receive it and you give it to your medical writer to, to finish and they say, but, but that is not what we need. We need this to [00:10:50] have the, the, the table the other way around or whatsoever. So the whole communication could have been done like at the very beginning, you know, you would save time and gray hair.[00:11:00] 

[00:11:01] Benjamin: Yeah, it 

[00:11:02] Alexander: has a lot to do also with delegation. Yeah, in a sense, you’re delegating [00:11:10] tasks, you’re delegating projects and all those, these kind of things. And it’s similar as if you’re delegating it within your own team. Yeah, you need [00:11:20] to make sure that the people you delegated to have all the resources and knowledge and so on so that they can actually succeed.[00:11:30] 

[00:11:30] Alexander: You need to make sure that you set them up for success. Timelines is is always a great topic because timelines [00:11:40] are, of course, moving targets. Yeah, so don’t wait until the last minute to, to tell, Oh, by the way, the database lock has [00:11:50] moved in by two months. And actually, we now have database lock in. Three weeks instead of in three months. So probably a [00:12:00] bad idea if you want to get your tables three days after database lock.

[00:12:04] Benjamin: That’s kind of the transparency in a way. Right. So that you kind of get the, you know, the [00:12:10] team updated and involved in the, I mean, they’re usually there’s no hesitance to, to, for this, for them, let’s say the outsourcing, the [00:12:20] statistician in the CRO to attend. Team meetings, I mean, maybe a cost factor, obviously, I mean, because of the time and then the, the units for [00:12:30] this, but in general, that would be so helpful for the statistician to plan within the zero all the timelines, the changes, the adoptions and everything.

[00:12:39] Benjamin: So that’s, [00:12:40] that is usually something that I recommend is to not, not only pass on information, but involve. The, the team to you know, to share [00:12:50] within the team to discuss possibilities. It’s also quicker, right? So if, if there are simple answers, yes or no possible, feasible, not possible, not feasible in a, in a way [00:13:00] within a team meeting, it’s easier to just.

[00:13:02] Benjamin: You know, just make, make the decisions, the right decisions at the right time or quicker, then going back to the statistician, to the [00:13:10] zero, to the outsourcing group to actually implement the changes and then realize, Oh, it’s not possible. We have to go back. So it’s there’s a lot of, a [00:13:20] lot of efficiencies you could gain if you know, if you’re, you know transparent with the with all the information.

[00:13:26] Benjamin: I know it’s not, not always possible with all information that’s understood. It’s [00:13:30] really, but there’s a lot of things that are being hold back and all found out sometimes by, you know, by chance and that is surprises. 

[00:13:38] Alexander: [00:13:40] You definitely need to make sure that you don’t have surprises. That’s always a bad thing. Of course, there’s sometimes the statistics organizations within [00:13:50] pharma companies get also surprised by, by changes. Yeah. But yeah, that’s, that’s a whole other topic.