By John Carlos Diaz, GeoSera Consulting
Clinical research is becoming more and more complex due to many factors, including increased regulations, competition for patients, and cost of conducting clinical trials. Most of the smaller pharmaceutical and biotech companies (sponsors) do not have the workforce to provide proper oversight of a clinical trial. This forces companies to outsource much, if not all, of the trial oversight to contract research organizations (CROs) and service providers (vendors).
When a sponsor company outsources the oversight of the trial to a vendor, the sponsor company is still required to ensure that there is proper oversight of the vendors and the trial. A problem is that many of the clinical staff tasked to manage vendors in a clinical trial lack experience managing people, especially managing people who do not directly report to them, such as outsourced vendor staff. You can imagine that managing indirect staff from a vendor can be a delicate and challenging responsibility.
In this article, I will discuss five rules that will help you effectively manage the sponsor-vendor relationship within clinical trials:
- Know your contract (SOW, MSA), so both parties can be held accountable for specific tasks.
- Establish clear roles and responsibilities for both parties — in writing.
- Create clear and realistic timelines and milestones for the trial.
- Distinguish between “nice to have” and “have to have.”
- Foster a symbiotic relationship to create the “team” mentality.
1. Know Your Contract
The first rule when engaging a new vendor has proven effective in holding vendors accountable for their responsibilities. The sponsor representative responsible for vendor deliverables and the success of a clinical trial should know the details of the vendor’s scope of work (SOW) and/or master services agreement (MSA). Knowing the contract language in detail is essential so that the sponsor knows the expectations of the vendor prior to initiating the trial. Also, by knowing the contract terms in detail, the sponsor is aware of the consequences of vendors not meeting contract goals, budgets, and payment schedules. Often, vendor and sponsor staff execute a contract, and then the sponsors fail to reference the contract after the trial starts. Not referencing the contract is a dangerous error by the sponsor because it leads to confusion on what tasks are to be handled by the vendor and what tasks remain for the sponsor to complete. Knowing which tasks are to be accomplished by the vendor and by the sponsor will lead to effective communication across company lines.
2. Establish Clear Roles And Responsibilities
Once you know the contract terms in the SOW, you can implement the second rule — set up clear roles and responsibilities, in writing, for each vendor in the trial. This task is simple yet incredibly valuable. By using the contract language, the sponsor can create a solid list of tasks that become the responsibility of the vendor. The roles and responsibilities can be detailed in each vendor’s project plan. The responsibilities must be easily accessible and not buried in an extensive plan that is not referenced frequently. Now, a sponsor may say, “The vendor should know what their tasks are for the trial.” As anyone who works in clinical research knows, every sponsor has different responsibilities for the vendor and sponsor to own. Also, large and small pharma/biotech companies have very different methods in conducting a trial, so it is of paramount importance that a list of solid roles and responsibilities for each vendor be provided. These roles and responsibilities need to be clearly communicated to your vendors.
3. Set Clear, Realistic Timelines And Milestones
Once you know the details of the contract and the responsibilities of the vendor, it is time to set up timelines and milestones for the trial. The third rule to manage vendors is to set up clear and realistic timelines and milestones. I stress “realistic” because if you set a six-day timeline for a task, such as final protocol, that generally takes six weeks, the vendor will roll their eyes, argue with the sponsor about quality issues and lack of time, etc., and eventually miss the unrealistic timeline anyway. You will lose time as well as generate animosity between the sponsor and vendor. In my opinion, the milestone that sponsors want to meet is first patient in (FPI) milestone. The FPI date is important because if the FPI milestone is achieved in the time projected, then Wall Street, investors, and stockholders are confident in the sponsor company’s ability to meet their timeline of drug approval, which leads to a stronger valuation of the sponsor company. So, if you set a clear and realistic FPI date and achieve this realistic milestone, then Wall Street and investors will look kindly on the sponsor company.
4. Distinguish Between “Nice To Have” And “Need To Have”
After you know the vendor’s contract and responsibilities and have clear and realistic timelines, it is time to dive into the details of the vendor’s roles and responsibilities. This is a time-consuming task, but it helps you distinguish between what tasks are a “need to have” versus a “nice to have” for the trial. In the ideal clinical trial world, there would be unlimited time and resources to conduct a trial with all the bells and whistles; however, clinical trials are rarely conducted in an ideal environment. Timelines are truncated and funding/resources are limited, so the vendor and sponsor must understand what you “need” for a successful trial or to meet milestones versus what is “nice” to have to meet the milestone. A lot of vendors know their responsibilities very well; however, vendors have a micro level of the goals of the trial. It is the sponsor’s job to convey the goals of the trial on a macro level so that the vendor knows that the vendor team needs to meet the overall goals of the sponsor.
Back to the FPI example: The sponsor’s executive team wants FPI by the end of the quarter, and this date was communicated to the public/Wall Street. Missing this timeline would be detrimental to a sponsor company’s stock price for a public company or to investors’ confidence in the company for a private company. If the sponsor can effectively communicate what the “need to haves” are to the vendor, then the vendor can focus their time on the “need to haves” and eliminate the “nice to haves.” This reduces timelines, meets the FPI at the end-of-the-quarter milestone, and increases public confidence in the sponsor company.
5. Create A Symbiotic Relationship
Finally, once you have all the details of the trial ironed out, the fifth rule to effectively managing vendors in a clinical trial is to create a symbiotic relationship between the vendor and sponsor. I have seen many sponsor-vendor relationships that are adversarial. I never understood this mentality. The sponsor needs the vendor to deliver quality, and the vendor needs the sponsor to clearly direct the vendor to success. If a vendor does not deliver, then a stern conversation is needed with the vendor’s management to understand why the vendor did not deliver, what will be done so that it does not happen again, and what financial implications there are for the vendor not delivering. If the sponsor is not clearly directing the goals of the sponsor to the vendor, then the vendor must escalate this to sponsor management, stating that the vendor cannot achieve their goals without clear, prompt instruction. The sponsor-vendor relationship does not need to be a friendly, personal relationship, but it should be a relationship of professional courtesy. This avoids adversarial interactions and makes managing the sponsor-vendor relationship more successful to achieve the overall goals of the trial.
These five rules can help you manage outsourced vendors in clinical trials with success — defining “success” as completing trials within budget and within timelines. The five rules focus the outsourced providers on achieving the goals of the trial while providing the sponsor with a transparent, snapshot view into where the trial stands relating to budget, tasks, and timelines for completing those tasks.
About The Author:
John Carlos Diaz has been in the pharmaceutical industry for 18 years with ranging operational experiences from preclinical drug metabolism and pharmacokinetics (DPMK), clinical pharmacology/Phase 1, adult/pediatric, global Phase 2–4, and investigator initiated trials. Currently, John is using his clinical research experience to benefit sponsor companies, clinical research sites, clinical trial service providers, and CROs. You can contact him via email or connect with him on LinkedIn.