By Dr. Beat Widler, managing partner, Widler & Schiemann Ltd.
Recently, we have been observing a change in the approach to outsourcing — more midsize and large biopharmaceutical companies are shifting to a strategic outsourcing model. Strategic outsourcing generally means assigning work to one or a maximum of two preferred (strategic) partners. The scope of outsourced tasks, however, varies, and no preferred model can be identified. For instance, some sponsor companies outsource all development activities to their partner(s) and only keep a core team to manage the partnership and ensure alignment with functions and services that are considered strategic. Other sponsors limit their strategic partnerships to study management and monitoring, but keep most of the other activities needed to plan, implement, and manage a clinical development program in-house.
What Does This Current Trend Mean Regarding Quality And Compliance?
There is an old principle in quality management: A company can delegate (e.g. outsource) tasks to third parties but will always remain fully responsible and accountable for all decisions, actions undertaken, and data generated by its partners. In other words, for biopharm companies, it’s the sponsor’s oversight or control of its partners that is paramount to achieving successful quality management.
You’ve probably heard the phrase “you can delegate tasks but not responsibility.” Following this tenet, sponsors must establish a robust process and system that enables seamless control of contracted third parties and of a company’s interfacing systems and processes. That process/system must include a way of quickly identifying significant deviations in outsourcing services and ways to trigger effective and timely CAPAs (corrective and preventive actions). CAPAs must lead to the identification of the root cause(s) of a significant GxP deviation. Therefore, the following are essential elements of an effective sponsor– service provider governance model:
- a contract that clearly defines deliverables and roles and responsibilities of each partner
- ways of measuring compliance
- a quality plan that proactively anticipates quality and compliance risks and describes and monitors effectiveness of these plans.
Some sponsor companies and CROs have implemented penalties when targets (e.g. missed timelines or poor compliance) are not met. However, unless these are coupled to objective performance criteria such as KPIs (key performance indicators) and KRIs (key risk indicators), these are not a sufficient oversight measure.
Navigating Between Micromanagement And Laissez-Faire Approaches
Micromanaging outsourcing partners is a risk every sponsor needs to avoid. With micromanagement, accountabilities clearly defined in the collaboration contract become undermined as the sponsor starts taking back activities and roles from its partner. Consequently, this affects the efficiency that was expected from the strategic outsourcing alliance in the first place. Typical examples of this sort of risk include using the sponsor’s SOPs or systems for tasks performed by the partner or creating complex approval processes for purely operational activities such as clinical trial center selection and onboarding.
But you should also avoid a hands-off approach to outsourcing management. The obvious risk here is a lack of control or oversight. You should be aware that there is lack of oversight when an outsourcing relationship relies on subjective progress reports written by the outsourcing partner, or such reports just address project management priorities (e.g. timelines, study progress) but do not include any objective and verifiable data about quality and compliance. You also don’t want those reports to identify deficiencies but do not contain evidence of adequate follow-up by the sponsor.
How Quality Risk Management Tools And Approaches Can Help “Our Navigation”
In our experience, the best approach is when each of the partners agrees on an integrated quality plan that includes:
- structured baseline reviews of systems and protocols (e.g. a failure mode and effect analysis [FMEA])
- tracking and follow-up on leading and lagging risk indicators
- verification of the adequacy of the quality plan through structured comonitoring visits and audits
- a routine process to review and act upon evidence of deviations from the quality plan or newly emerging compliance and quality signals.
Overall, the key to success is outlining structured controls that leverage existing data rather than generating a tide of new questionnaires.