Everyone is outsourcing all the time and it surely comes with challenges and opportunities. 

If you struggle – either on being on the sponsor or the CRO side – you’re not alone.

Join me, alongside Benjamin, as we discuss the complexities of outsourcing in our field. As statisticians and data analysts, why do we turn to outsourcing in the first place?

What strategies can we employ to overcome the hurdles associated with it?

Together, we’ll explore these questions and more, offering practical insights and solutions to enhance your outsourcing endeavors or to work more effectively with sponsors.

So, grab your headphones and join us on this enlightening journey into the realm of statistical outsourcing while we tackle the following key points.

Key Points:

  • Necessity of Outsourcing
  • Essentials of Successful Outsourcing
  • Anticipated Challenges
  • Taking Care of Outsourced Teams
  • Effective Strategies
  • Benefits of Outsourcing

Navigating the challenges of outsourcing in statistics and data analysis requires a strategic approach and a commitment to effective communication, collaboration, and careful planning.

By addressing these challenges head-on and implementing the strategies discussed in this episode, statisticians and data analysts can harness the power of outsourcing to enhance their capabilities, meet project demands, and drive success in their organizations.

CRO staff will also benefit from this episode. 

Share this episode with your friends and colleagues to spread the knowledge and empower others in our field to overcome outsourcing challenges and achieve excellence in their work.

Together, we can foster a community of informed and skilled professionals dedicated to advancing the practice of statistics and data analysis.

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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. 

[00:14:00] Let’s speak a little bit about money and budget. What are kind of typical. Challenges you see around [00:14:10] budgeting and these kinds of things.

[00:14:12] Benjamin: I mean, usually, you know, it’s always too much money, right? 

[00:14:17] Alexander: Company is asking for the, so [00:14:20] that is, 

[00:14:20] Benjamin: that is kind of the, the overarching you know, no, but that’s, that’s, no, that’s, that’s not true. I mean, the, usually they’re, you know, when, when my experience is that [00:14:30] there’s usually quite a good understanding of what, you know, what the pricing is about right.

[00:14:36] Benjamin: So it’s so that they’re, you know, how the structure is. So [00:14:40] most of the, you know, most of you know, the clients that I work with have had similar experience or similar outsourcing type of way before. So, I [00:14:50] mean, still CROs work differently, so you have to be, you know, what I sometimes experience is that the the, the, the, the, [00:15:00] their own need for.

[00:15:02] Benjamin: Understanding how the processes work in the CRO is not necessarily available. So that means [00:15:10] if you do like a pricing, like you provide an price or you have an idea of how it works with, you know, the different types of programming, the QC, [00:15:20] the within the timelines, the time or the project management time that you need as a, you know, as a company and so on and so on.

[00:15:26] Benjamin: So all the details. There’s usually, or there’s [00:15:30] quite often pushback and saying, well, we don’t need this which is not true because it’s, it is not something that actually is needed for, you know, for the [00:15:40] sponsor, but it is needed to actually provide the work that, that the CRO is doing, basically internal.

[00:15:48] Benjamin: Hours [00:15:50] that are directly related to the 

[00:15:53] Alexander: specific project 

[00:15:55] Benjamin: project management, for example, or, you know, attendance of meetings or internet [00:16:00] meetings or like things that are just, you know, blowing up the budget in a way, but actually do not directly or it’s not a delivery. [00:16:10] So so that is, that is something where, where I often, we often have discussion and explain a lot about how the processes work.

[00:16:18] Benjamin: So what is the, [00:16:20] what is the, the background of this budget, this units. So that is, that is one, one thing where, [00:16:30] you know, where I often had explaining and describing how, how this works. 

[00:16:37] Alexander: Well, you know, you can have this unit [00:16:40] as a line item in your budget, or you don’t. If you don’t, then the CRO will split it up and distribute it across all the other [00:16:50] units.

[00:16:50] Benjamin: I think this is, this is sometimes done probably, and sometimes it’s not. So, and that is, that’s why, you know, then, then, you know, we, we often receive these comparisons [00:17:00] where you say, but I have another CEO that only, you know, that there is where the unit costs only this and this or more or less than that.

[00:17:08] Benjamin: So there’s, there’s like a [00:17:10] comparison, which I always feel is kind of between, you know, apples and pears. Because if you don’t, you know, if you do not show the full pictures, just Cherry pick [00:17:20] items out of it, then, you know, start discussing about the price of one unique table, but not the rest of it.

[00:17:28] Benjamin: And [00:17:30] so, so that is, that is that is usually the pricing, the most challenging pricing part is to, to explain or to kind of get a, get [00:17:40] an alignment in, in what work is actually, actually needed to deliver. What the CRO [00:17:50] believes is needed. And again, I’m saying believes because this is not always clear either.

[00:17:57] Alexander: Yeah, that is one of the other things. What [00:18:00] I have seen quite a lot from both sides has said, there’s no discussion about it. It’s more kind of exchange of [00:18:10] documents. And my experience is the best budgets come out of a discussion [00:18:20] between the vendor, CRO, and the sponsor the vendor statistician and the sponsor statisticians to sit together to go through all the [00:18:30] deliverables.

[00:18:31] Alexander: reach a common understanding, make sure that there’s no no misunderstandings, or at least reduce the number of misunderstandings. And [00:18:40] then you get to a much better budget. Yes. 

[00:18:44] Benjamin: Not necessarily in the beginning, to be honest, because this is usually higher because you understand what is needed. [00:18:50] But at the end, because of the, you know, the, the, there’s no change order, you know, like less of change orders.

[00:18:56] Benjamin: So the, it’s actually, it’s a, it’s a realistic budget. That [00:19:00] you, that you really try to receive or try to agree on in the very beginning rather to say, okay, so this is the specs. So we bid to the specs and then you [00:19:10] receive the protocol or the SAP or write the SAP and realize, okay, it’s like three times as many outputs.

[00:19:15] Benjamin: So, and actually there’s an interim and there’s another interim. And then we have a DMC. [00:19:20] And then, and and I mean, that is something that, that some, you know, they, I mean, there are, there are strategies from clients. What we see is that they, they have specs and they [00:19:30] require all CROs to exactly bit to the specs.

[00:19:33] Benjamin: Just for the comparison type of way. So that is, I mean, that is fair if they’re honest and open about it. So you bid to the specs and [00:19:40] that is kind of the decision making. One of the decision making you know parts is the budget so that, you know, and you see it’s double the price, half the price. They may have like a [00:19:50] preselection already, but actually, as you, as you said, the, the most important part is the budget at the end.

[00:19:57] Benjamin: Right. And this [00:20:00] is something where, where we need to talk and we need to see, you know, on the one side, we need to understand what is, you know, what the [00:20:10] plan is to give our best expertise to it. And on the other hand, you know, I would, you know, I would recommend also to, to listen to people that actually have done [00:20:20] this before many, plenty of times, right.

[00:20:22] Alexander: Yeah. Yeah. If you work first time with a new vendor, you know, [00:20:30] or have this first time iteration, it is really important to have an expectation of [00:20:40] you need to do a lot of communication and have an expectation of you There will be misunderstandings that it is [00:20:50] just nearly inevitable, you know

[00:20:52] Alexander: really smooth. It only gets, if you do many different projects together I’m absolutely sure there’s [00:21:00] no perfect vendor sponsor relationship that starts super smooth out of the get go. Yeah. [00:21:10] So don’t, you know, if the first project doesn’t go smooth, yeah, don’t throw in the towel and say, Hey we’ll never work [00:21:20] with that vendor again.

[00:21:21] Alexander: Yeah. Also from also Listen from a, from a client side from a, from a vendor side, this sponsor is so [00:21:30] difficult. We never want to work with them again. Yeah. Don’t throw in the towel too early. Yeah. Do another and another project. [00:21:40] And then usually you can make a much more better informed decision, you know, outsourcing just one project.

[00:21:49] Alexander: That goes [00:21:50] and then I think 

[00:21:52] Benjamin: I agree. And especially if you have, you know, when, when I see this from, from the CRO side when you [00:22:00] know that there’s more to come and like longer way of planning possible, you can also make, you know, the best. The informed decisions about who to assign [00:22:10] to keep the assignments because people, you know, people learn to, to work with a vendor, obviously.

[00:22:17] Benjamin: So it’s, it’s kind of, they interact, they have, [00:22:20] they know where the, you know, maybe pitfalls are different communication ways, or maybe what I mentioned before, different, you know, same naming, but different meaning type of type of things. So they [00:22:30] really learn how to best approach and to, to work with you.

[00:22:35] Benjamin: a vendor or at least a group or like individuals from that, from that, from [00:22:40] that company. So, and we, you know, even though for example, in our, in our case, we always try. Keep this [00:22:50] experience alive with the vendor. So give it, pass it on. However, if this is not a planned exercise, so if this is something that comes spontaneously, [00:23:00] it makes this harder for us to actually keep the assignments or to, to have the same people assigned or the same group assigned again.

[00:23:09] Benjamin: [00:23:10] And so that’s why I fully. I’m supportive of the idea of, you know, having not planning for bits and pieces and [00:23:20] individual, you know, small parts of the of the project life cycle, but really to have a longer. You [00:23:30] know, partnership, I mean, partnership is always on so big, but actually it is, it is kind of a trust that you need to build up in [00:23:40] from both sides and not just work it off like on a, you know, like a tick boxes and yeah, yeah, yeah, 

[00:23:47] Alexander: completely agree. 

[00:23:49] Benjamin: [00:23:50] Actually for the, for the staff. You know, the commitment of the individuals, it is much easier than for them as well. Right. So if they feel it’s kind of a, [00:24:00] you know, you it’s your, it’s your client, it’s your sponsor, it’s your project, it’s your, you know, it’s your drug, whatever. So you, you, it’s just a different.[00:24:10] 

[00:24:10] Benjamin: Type of involvement that you are happy to give as if you just receive something and say, well, just work it now, program it now, and then, you know, go home. [00:24:20] So, 

[00:24:21] Alexander: yeah, completely agree. It’s, it’s the same from the sponsor side. Yeah. If you can work with the same team, [00:24:30] your same key contacts over a longer period of time, it’s so much more fun, more [00:24:40] satisfying just easier, you know, and one of the under underlying things there is because you build trust.

[00:24:48] Alexander: Yeah. [00:24:50] And building this trust usually takes some time and yeah, the experience, yeah, is the same thing, kind of knowing the [00:25:00] way, different ways of working. You don’t want to train someone new again and again and again and again. Yeah that’s a lot of [00:25:10] cost and a lot of pain. So look for longer term partnerships and make sure that both [00:25:20] sides have yeah, get, get something positive out of this partnership.

[00:25:24] Alexander: That is really important as well. Thanks so much. That was [00:25:30] a great discussion. I have the feeling we just. You know, had a, had a glance on the, on the ceiling of the [00:25:40] iceberg. 

[00:25:41] Benjamin: There’s definitely more we can also exchange about, I mean, we haven’t really discussed timelines. Right. So that is, that is a critical part or, you know, [00:25:50] other therapeutic areas, specific type of things.

[00:25:53] Benjamin: So where you kind of so there’s this there, you know, this is, this is this is a whole industry obviously, and, [00:26:00] and with that is a lot of challenges, it’s, it’s a lot of success as well. So it’s, it’s really like a great, great place to work. In a way, [00:26:10] but really, you know it’s, it is kind of, it’s looping back in a, in a way where you say, you know, when we, I, I remember we had long, you know, years ago, the discussion about the [00:26:20] whole programmers and statisticians work together.

[00:26:22] Benjamin: Right. So, and it is, it is kind of looping back to that is where you, you know, when you expect. [00:26:30] You know, when you partner with the, you know, with the other groups and with the under other individuals and not, it’s not a top down kind of mentality, but really like a [00:26:40] partner, that is the biggest success, right?

[00:26:43] Benjamin: There’s the biggest potential for it. And that is the same for, you know, for for the relationship, the COOs. And [00:26:50] so the ones where you have trust, openness, honest relationship, the outcome is. Usually the best, right? Yep. [00:27:00] Yep. As simple as that. 

[00:27:02] Alexander: Awesome. Yeah. And I think this was episode number two or three how to work with a programmer or [00:27:10] a programming team from a statistics side.

[00:27:13] Alexander: So you probably need to scroll quite a lot back and search for it. Yeah, give it a [00:27:20] listen. Thanks so much, Benjamin, for a great discussion again. 

[00:27:23] Benjamin: Sure, Alex. Have a good day.

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