In this video recorded on February 2020, we discuss 5 Best Practices for Designing Your Request for Proposal (RFP) Package Within Clinical Trials.
TRANSCRIPT FROM VIDEO
Hi everyone and welcome to another episode of ClinBiz, where we love connecting with you on the business aspects of clinical trials. So, in today’s video, we’re actually going to be talking about some best practices. The things you need to include when you’re designing and putting together an RFP package out for your vendors within your clinical trials. So, if this topic interests you, make sure you stay tuned for the video and also make sure you subscribe to our newsletter at ClintBiz.com. Because we’re going to be having a full course rolling out in the next few weeks and that way, we can let you know whenever the course opens up. Alright, so stay tuned.
Hi everyone! Welcome back. So, let’s talk about some of these best practices and things you need to include when you’re designing and putting together an RFP package out for your vendors. So, just as a background for those that are not very familiar with the process, for clinical trial usually a study sponsor will engage with a vendor, a CRO or a different vendor. To accomplish actually a specific task or service within the clinical trial that the sponsor does not want or doesn’t have the people internally to actually complete that, those tasks. So, they engage with a vendor with a CRO for those tasks to be completed. And in that process, a procurement or sourcing process needs to take place in order to source out which vendors are the best, to get they’re costing and information.
And in that whole process there’s the RFP stage. There’s a Request for Proposal stage. That’s where to study sponsor is actually sending out an official request for all the vendors that they’re interested in engaging. So, that they can the vendors can actually provide to the sponsor an official proposal how much their services would cost if they were to be performing them for the sponsor for that trial, right. So, just with a little bit of a background there, let’s jump in to the things that you should be including. Alright, so number one well you should be including in the RFP package that you’re sending out to your vendors is some type of a project definition.
And by that we mean, what are the timelines associated with this RFP process or to contact people that your vendors should be reaching out to if there are any questions in the process. Are you going to be allowing any questions throughout the RFP timeline? Are going to be allowing any questions from your vendors? Are you going to be allowing them to know who their competitors are or not? So, really defining the rules of the game, you need to be talking about those things in some type of a project definition area within a document or it doesn’t have to be a full document itself. But just in some type of way you need to be defining how this project or this RFP process is going to look like for your vendor, so that they know exactly the expectations that you have within this.
The second thing you need to be making sure you’re including in this package is especially for a clinical trial it is the protocol or the study assumptions. And by that we mean you need to be including things such as a protocol draft or a synopsis within that package to your vendors. You need to be including things such as the schedule of events, obviously would be in a protocol if you’re including that your investigator brochures depending on the services your vendors will be providing for you. Also, the things such as number of patients, number of sites, countries. They are going to be using for that clinical trial. So, again some of these can be tailored for the type of vendor you have in the type of service they are going to be providing.
But these things absolutely need to be included in your RFP package out to your vendors. Because it’s really going to help them to provide the best costing the best proposal out to you. And it also brings up additional questions that you need to be asking throughout the process, right. So, the number three thing you need to be including in there, and again this is not a complete list of things you need to include, will have that complete list and that complete information within our course. But for here today, at least these are some top things you need to include in your RFP package.
Number three would be to include some type of a racy document. And my RACI I mean RACI the acronym that stands for. Who is going to be responsible for a task within that relationship? Who is going to be approving? Who’s going to be consulted and who’s only going to be informed of certain tasks and situations in that relationship? So, you really need to be including some type of a document or some at least an area within that full document providing to your vendors in this package. You need to be including a section that is a RACI section. Because this is really going to be telling your vendor exactly the expectations and their responsibilities for each task.
This is very important, because let’s say for example you as a study sponsor are under the assumption that the vendor is only going to be informed about a certain thing in a trial. And your vendor is actually under the incorrect assumption that they’re going to be actually responsible for that task. Well, that makes a huge difference when you’re actually providing numbers for you and they’re actually providing costs of how much that would cost for them to do that task. Because they’re thinking they need to employ more resources, they need to employ more time because they are actually responsible for that task.
So, very important that you define these expectations and these responsibilities via some type of a RACI document or RACI section within your request for proposal package that you’re sending out to your vendors. Okay, the next thing is very important that you include in this package is, some type of a budget grid or a budget grid guidance. And by that, I mean, if you have a standardized template a budget template that you as a study sponsor have that you send out to your vendors when you’re doing the RFP process, that’s great. And you can send those out with that package and your vendors will be able to send all that information back in your own little format. And you’ll be able to compare it easily.
You can also ask for the vendors to provide in their own format, their budget grids and their proposals. And there are upsides and downsides to both, I’ll say for the standardized way whether it’s a template or whether it’s a system you’re using. Obviously, you’re able to as a study sponsor compare much easier apples to apples when the different vendor proposals come back in the different vendor budget grids. You’re able to better compare those things, because everyone has done it in the same similar format. Whereas if you don’t if you have the vendor providing in their own format, well then it may be a little bit quicker for the vendor to turn that around for you. Because they are used to the format, but it may take you more time as a study sponsor to actually evaluate all of those different proposals and different formats. And so much more difficult to pick through much more time-consuming.
So, there are pros and cons to each, but just make sure that you have some type a budget grid or a guidance on what your expectations are regarding the vendor providing some type of a budget back to you. Whether it needs to be in a standardized format or it could be in a non-traditional or non-standard format, okay. And then the last point will cover for this video, again not a full list we’ll have that in our course. But for the purposes of this video something I think it’s very important that you also include. If you did not include this earlier within that conversation with your vendor is to include any specific sponsor requests. And by that, I mean, if you have a specific request let’s say you want people that are going to be associated with a certain task that that vendor is going to be doing. That you want them to have a certain level of education or you want them to have a certain level of experience or certain degrees.
Let’s say you want their resume there’s TV. You want to be able to include this if you have not done so earlier in an RFI stage, which is something we’ll cover in the full course. You want to make sure you’re including here in the RFP stage. And you’re including this in the package out to your vendors. Saying any special requests, you may have. This is important. Why? Because some of the things may not really have a budget impact, it may simply be something that you know may have a little bit of the time concerning your vendor will have to search out from some information. But some things may actually have a budget impact if you’re requesting them to do that.
So, it’s very important. It may have other impacts; it may have some logistical impacts. So, you want to make sure any special requests they are going to be needing during this process and also later in the study that you’re including as much information as you have at that point for your vendor. Because it’s really going to help them to cost out the proper things for you and later down the stream not have as many hopefully change orders coming through for things that we’re miscommunicated in the beginning. All right, so there you have it just a couple of best practices for when you’re designing sending out your RFP package all to your vendors.
Related Terms: clinical outsourcing, clinical trial outsourcing, clinical trials, clinical research organization, cro, request for proposal, rfp, bid grid, rfi, RFI, strategic sourcing, sourcing, clinical vendors, clinical study