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International Clinical Trials

True Partnerships

Nelson Lee at the Society for Clinical Data Management (SCDM) reviews some lessons learnt from building a functional service provider partnership

The traditional full-service CRO model for clinical data management (CDM) is evolving into something different – a functional service provider (FSP) model. Instead of outsourcing the entire suite of CDM tasks, sponsor companies only outsource selected CDM activities, maximising operational and budgetary efficiency. While this model has become a key player in CDM resourcing strategy, it is a complex partnership and requires careful planning and examination prior to implementation.

A successful FSP partnership is critical to CDM operation for pharmaceutical and biotech companies. While a well-planned FSP implementation is a good starting point, a long-term strategy for building and maintaining an FSP partnership is equally important. When an FSP is selected, it is merely the beginning of the partnership journey. It takes numerous considerations and planning to ensure a successful implementation. Furthermore, many of the implementation steps are critical to – and have a profound impact on – the partnership. This article will share some key lessons learned in FSP implementation and maintaining FSP partnership from a sponsor’s perspective.

WORK ORDER

It is important to establish a process to outsource works to FSPs. A simple and effective way is to use a work order that states the tasks the FSP will support. The tasks should be specific enough that they do not leave room for different interpretations. Consider the task edit check programming. If this is all that is listed, the FSP could interpret the requested service with any level of details. Are unit testing and quality assurance activities part of this task? Who is responsible? Is the FSP responsible for all types of edit checks?

The key lesson here is to ensure a clear understanding of the full scope of any tasks the FSP is responsible for. This leads to the importance of setting clear expectations and understanding of common terminology and processes.

Edit check programming can be broad. As electronic data capture (EDC) gains a foothold in CDM, it is imperative to understand exactly what edit check programming means.

There are different types of edit checks. The most common type is discrepancy checks. For example, when checking for a current visit date, the date must be after the informed consent date. Some checks are programmed to ensure certain data flow and form logic. If ‘female’ is entered in the gender field on the demography form, a logic check will be engaged and make the serum pregnancy form available for entry.

EDC systems have multiple built-in, or system, checks that do not require programming. These checks can be easily implemented by merely turning on built-in features. Checks that require a response or ensure conformant data are common system checks.

While a work order can easily be prepared by a clinical data manager, there must be a control point on the outflow of work orders to ensure FSP support is used properly by staff. It is advisable to have a point person internally who can authorise the work order. Likewise, a point person on the FSP side should be designated to receive and authorise the work order. If there is no agreement, the FSP must not start any work, even if a work order was received. Only authorised and agreed tasks between the sponsor company and the FSP should be performed.

THE TERMINOLOGY TRAP

Setting clear expectations is critical. There is jargon in the CDM community that means different things in different companies. The keys are to avoid making assumptions and to ensure the FSP has the same knowledge of the CDM processes employed internally.

Some companies include unit testing and quality assurance as part of the edit programming practice, some include quality assurance procedures in user acceptance testing. Likewise, some companies require the programmer who programs the checks to perform unit testing, some require a different programmer to perform the task.

To avoid confusion, the FSP needs to be educated and trained on the same practice. Specific requirements, including study-built conventions, must be transparent and clearly communicated to the FSP so they can meet the expectations of the sponsor. If unit testing requires two sets of testing data (one to trigger the checks, one to pass them), this requirement must be communicated to the FSP upfront.

KNOWLEDGE AND EXPERIENCE

Let us look at another scenario, where an FSP study requested edit check programming support. The FSP assigned an experienced clinical database programmer to lead a team of three other programmers. When the sponsor conducted an internal review of the FSP deliverables, they found an unusually high number of programming errors. Further investigation identified one of the programmers had four times more errors than the rest of the team.

The FSP revealed that this programmer was a new addition to the pool of candidates in the FSP model and was a replacement for a senior programmer. Though this new programmer had all the proper training documents, he had no experience performing programming work in the EDC system employed by the sponsor.

FSP staff turnover is unavoidable and is uncontrollable by the sponsor company. The minimum requirements to carry out CDM tasks by job title must be set and shared with the FSP. The FSP is expected to use the same criteria to assign a pool of qualified candidates because the sponsor is expecting turnkey operations in the FSP model. Outsourced CDM activities are not meant to be a training opportunity for the FSP staff. If the sponsor requires an internal employee to have certain knowledge and experience to handle a specific task, the same set of criteria must apply to FSP staff doing the same task. Failure to meet these expectations will have a ripple effect and can result in quality concerns or missed timelines.

Let’s go back to the above scenario of FSP programmer errors. The FSP took immediate action and implemented an extra step to review all work done by the new programmer. Though the team was able to meet timelines and quality expectations, the extra review and necessary corrections generated a higher number of reported work hours, resulting in higher billable hours by the FSP.

The sponsor company now wonders why they are stuck with the extra cost. This damages the trust and confidence in working with the FSP (and in particular the programmer) – and its reputation. The cost-benefit, quality expectations and timelines must not be negatively affected by less trained or inexperienced staff. These factors are key to successful CDM deliverables and to the successful FSP partnership.

STAFF SATISFACTION

It is no secret that there is a cost-benefit component in using FSPs. And it is nearly inevitable that internal CDM staff sense a threat in their job security. Employees frequently become concerned that they will lose skills as tasks are outsourced. This concern needs to be addressed promptly by CDM management of the sponsor company, enabling full cooperation and acceptance, or at least minimised resistance, from internal staff. Management must communicate the rationale and benefits, according to the unmet medical needs, to the trial, to the company and to staff, of adopting the FSP model. Moreover, employees must be given a clear vision of career development opportunities that are available, especially in light of more routine tasks being given to the FSP. In this manner, they see the value of their contributions and will be engaged and supportive. A good example would be to assign CDM staff to perform core functions, such as making final decisions on edit check specifications, or lead projects while FSPs take on a supporting role. Employees can be surveyed on their satisfaction to gain insightful information about the status of the FSP partnership at the individual level – knowledge that can be applied to further enhance the partnership.

THE UNEXPECTED LIMITATION

Some clinical data management system (CDMS) vendors may require a contractual business relationship as a training support prerequisite. These vendors will only provide training support to an FSP if such a business relationship between the vendor and the FSP exists. FSPs may not be able to support certain tasks because they couldn’t get the training. This not only limits the scope of tasks the FSP can perform, but poses a challenge to the partnership.

Some sponsor companies may opt to fill the gap by providing the training directly to FSPs, but not everyone has this option. This creates an additional resourcing burden to the sponsor companies, as they have another responsibility for training FSPs. One may question the efficiency and effectiveness of this approach, and sponsor companies may turn to consider other FSPs capable of supporting CDM tasks without limitation.

CONCLUSION

The FSP model can be an effective tool in the changing work environment in CDM. A true partnership is much more than a series of joint activities. It entails devotion and consistent planning, effort and resources. The trio of timeline, cost effectiveness and quality is the common key measurement in evaluating the success of an FSP model. But internal staff satisfaction and support deserve to be added to this equation as well.

Clear and transparent expectations will minimise many issues that can affect an FSP partnership. As we always say in CDM, never assume. It is the joint responsibility of the sponsor and the provider to ensure each FSP employee involved in CDM tasks is qualified. Their education, training and experience must be thoroughly evaluated and followed through. Like many other partnerships, an FSP partnership relies on a comfortable work relationship where each partner is confident that they are working on the same page.


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Nelson Lee, CCDM, is chair of the Society for Clinical Data Management (SCDM) Marketing & Communications Committee and a senior clinical database programmer at Genentech. Nelson has more than 12 years’ experience in the CDM industry and has held a range of positions in clinical data management as an individual contributor and a manager. He is active in the CDM community and is past chair of the SCDM Membership Committee. Email:
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