If you are like most small biotech companies, your budget is small and your timelines are as tight as possible in order to get the data needed to support the next round of funding and take the next step in your clinical development program. The best insurance you can use to achieve that next step and end up with a high-quality study that will pass an audit or inspection is proper planning ahead. This article will focus on proper resourcing of a sponsor’s internal clinical operations (ClinOps) team to adequately support a clinical trial during study startup.
To date, one critical SME has been left out when adopting an eTMF, whether it’s outsourced to a CRO to manage, outsourced to a third-party vendor, or maintained and managed in house at the sponsor (or some combination thereof — which is an article for another day!). Can you guess who that SME is?
Many of you have no doubt heard someone in your current or past organization say, “Quality, cost, and speed — pick two.” This statement refers to the perception that a project cannot achieve all three areas as priorities and therefore the organization must choose which two out of the three to prioritize.
When a pharma or biotech sponsor company engages with a contract research organization (CRO) and other service providers, it develops a list that details which organization is responsible for each task to be conducted. The degree to which a small to midsize sponsor has the expertise and the resources internally to manage a task, as well as budgetary constraints, will dictate which tasks it delegates and which it keeps in-house.