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Logistics to Consider When Setting up a Strategic Medical Writing Partnership

June 23, 2016 | Tim Garver, PhD, Executive VP and Chief Operating Officer | Medical Writing Services

In an earlier blog post, I introduced you to the concept of a strategic medical writing partnership and explained why you might want to set one up for your company. In this post, I’m going to get into the nitty gritty of how to set one up – including what you should consider when establishing a partnership as well as how to keep it going successfully once it has been established.

In our experience, considerations at the start fall into two buckets – business considerations and operational considerations. Let me help explain.

Business Considerations

The business aspects that need to be considered when setting up a strategic medical writing partnership include contract negotiations, defining the scope of work, establishing agreed pricing and Sponsor financial incentives, and understanding the timing of the work that could follow.

  • • Contract negotiations

As you’d expect, a partnership is not possible without having a contractual agreement in place between the Sponsor and CRO. This contract usually is in the form of a Master Services Agreement (MSA) – a document that houses the legal language around such topics as confidentiality, indemnification, intellectual property, financial considerations, etc. The legal team for each company should be involved in this step.

Agreeing to contractual language upfront allows the CRO to be more agile once work is assigned, with the ideal scenario being only that a statement of work is needed to get any individual project underway.

  • • Defining the scope of work

After setting up the contract, the second step is to define the scope of work to be carried out by the partnership. In one of our current partnerships, this includes writing and primary publishing of approximately 25 to 30 CSRs per year. I’ll use this relationship to provide examples throughout the rest of this post.

In this case, metrics for each CSR type (by number of objectives/endpoints and other considerations) were used to determine a CSR’s overall level of complexity. We then came to agreement on what constitutes a “standard” and “complex” CSR by phase of development (Phase 1 through Phase 4).

Because a goal of this partnership was for the CRO writers to fulfill all of the responsibilities typically managed by the Sponsor’s internal medical writers, we agreed to use the Sponsor’s internal metrics as a guide for how many hours would be required to complete a CSR based on its level of complexity.

  • • Establishing agreed pricing and Sponsor financial incentives

The third step in working through the business considerations in establishing a partnership is to come to agreement on pricing and financial incentives.

Given that our medical writers were to function as the Sponsor’s medical writers, we used the Sponsor’s internal metrics for how many hours were needed to complete a given CSR. Once both parties came to an agreement on hourly rates by position (eg, medical writer, quality control reviewer, publisher), determining and coming to agreement on unit prices for CSRs was made easy in this partnership.

In addition to settling on costs, other financial issues need to be negotiated to allow for the partnership to run smoothly. First, a maximum “inflation rate” is usually agreed upon, thereby obviating the need to renegotiate hourly rates and unit prices each year. Such was the case in setting up this partnership.

rebateNext, when establishing a long-term partnership, it is common to negotiate certain pricing incentives to the Sponsor, whether they be in the form of reduced hourly rates, rebates based on volume of work, or other such incentives. In the case of this partnership, we agreed to the volume rebate approach (ie, each contract year, if we hit certain revenue milestones as a result of work from the partnership the Sponsor receives a percentage of that revenue back in the form of a volume rebate). Volume rebates provide a financial incentive for the Sponsor to outsource large volumes of work to the CRO – which is certainly something we like to see on the CRO end!!

  • • Timing of work

Another advantage of a partnership is that it typically involves a pre-defined (and often large) volume of work. Because of this volume of work, it’s also possible that the timing of work is known in advance and can be communicated accordingly.

Agreeing to the timing of the work (and who will do it) in advance of the timelines for each individual document is mutually beneficial to both parties, as the Sponsor is assured that the work can be completed and the CRO is able to ensure the best resource has been assigned.

Operational Considerations

Now that you have all of the business aspects taken care of, it’s time to think about how the partnership will function on a day-to-day basis (ie, operationally). It is crucial to success that you agree to clear expectations and procedures for the following operational components at the start of the partnership:

  • • Training

Of course, whenever you enter into a partnership, training will be required. The question is: what does the CRO need to be trained on, when, and by whom?

Training is required on all applicable SOPs to be followed, all/any of the Sponsor’s systems that will be used (eg, the electronic document management system [EDMS]), and any other Sponsor-specific information that the CRO may be required to understand and implement.

At the start of the project, the CRO should be trained on all applicable processes by the most qualified person for that process.

  • • The writing process
It is also crucial that the writing process be agreed upfront. This means: what processes will be followed for review, QC, and approval of each document? Will there be an internal CRO review? At which draft(s) will the QC occur? Questions like these are important to nail down – typically by following the Sponsor (or CRO’s) already established SOPs.
  • • Communication is key!

keyAs with any partnership, communication is key. It is important to establish how communication will occur for the partnership as a whole. Particularly, who keeps an eye on how the partnership is operating and whether it’s working? Establish who the players are, how often they report, and what they report on to measure the effectiveness of the partnership (more on that below).

In addition, it’s crucial for communication to occur on the individual document level (in our example case, for each CSR). It’s critical that the internal point of Sponsor contact and the CRO writer can communicate freely and often to ensure they are on the same page. It’s equally important that the CRO writer can communicate freely with the project team to reach effective decisions as needed. In our example case, it’s imperative that the CRO writer can work in the same way and with the same effect as an internal Sponsor writer would, as this is the expectation of the partnership.

  • • Key performance indicators
It’s important to agree in advance to the key performance indicators (KPIs) that the CRO will be held to. These are typically timeline based (eg, a certain amount of time from final tables to approved CSR) and are a fairly easy way to measure whether the CRO is meeting the expectations required from the partnership. The Sponsor and CRO should agree to these KPIs before work begins. Deviation from the agreed upon KPIs should be discussed and evaluated to identify the root cause of the deviation.
  • • Partnership governance and issue escalation

partnersWhile the desire is for everything to go swimmingly all the time, the reality is that issues may arise in any partnership. When they do, it’s important that a partnership governance body/leadership team made up of members from both the Sponsor and CRO already be in place in order to address such issues.

It’s imperative for this body to understand their remit (ie, to make sure both party’s needs are being met sufficiently) and for this governance body to provide an honest venue to discuss issues and situations freely. This team will be the one to steer any course corrections, if needed, and to ensure the partnership continues to meet the needs of both parties over time.

Once you have addressed these operational considerations, your partnership will be set up for success. Making sure expectations are agreed to upfront is absolutely crucial for a successful partnership. While all of this upfront work may seem extensive, it is actually the best way to ensure that the partnership works effectively and that the CRO partner can begin work as quickly and efficiently as required by the Sponsor.

Let us know what you think

That’s enough from me. What do you think about strategic medical writing partnerships? Have you ever established one? If so, please let me know how it went and if you have any other experiences with setting one up. Feel free to contact me, or better yet, come talk to me at the DIA annual meeting next week in Philadelphia, where I will be co-presenting on this topic on June 30th, 2016. I look forward to hearing from you or seeing you there!

All images courtesy of Stuart Miles from freedigitalphotos.net.

Category: Medical Writing Services
Keywords: strategic medical writing partnership, strategic partnership, regulatory medical writing

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