Hybrid Model

Many biopharmaceutical companies are adopting what we call a “hybrid” approach to clinical study management. In this model, you choose which services to outsource to a CRO and which services you will manage through vendors of your choosing. For example, you could contract with a CRO for clinical monitoring services and then choose specialty vendors (data management, drug safety, IRB, etc.) for all other services. This model protects the sponsor from a full service CRO that does not perform optimally for certain services that would make it difficult to get out of part of a full service contract. It allows the sponsor to be more in control of the various stages of the clinical drug development life cycle by allowing them to choose the vendors that they work well with rather than being forced to use the CRO infrastructure. Similar to the CRO Management model, MVG Consulting can provide contract staff to the sponsor to help them to manage the various vendors in use during a study. We can also help in the search for vendors and provide vendor qualification audits from a Quality Assurance perspective. Additionally, we can make sure that your company has the appropriate SOPs in place to support working with this model.