Outsourcing in Clinical Trials is very rampant these days, the initial days of outsourcing started in the 1990s. What exactly does this term “outsourcing” denotes in Clinical Trials? In business terms, outsourcing refers to contracting the business to a third party.Most pharmaceutical companies outsources their business (in this particular case we are referring to advanced stages of clinical trials, which are usually multicentric) to Clinical Research Organizations, otherwise known as CROs.
The decision of outsourcing in clinical trials can be taken at 2 levels namely called as the strategic level or tactical level. Strategic level outsourcing is long term and involves partnering with a specific and selected vendor. Tactical outsourcing is short term which tends to focus on individual clinical trials. As like all business ventures to be successful, it is very important for both the parties to have a clear understanding of what they need from each other. All aspect of vendor managements is important, right from knowing what kind of CRO to choose from till the final agreement between the sponsor and the CRO. All legal documents should clearly mention the terms and conditions of the contract between the two parties and the contents of such documents should be mutually agreed upon by both the parties. It is very important for the clinical research staff to have a basic understanding of the topic, especially emphasizing on the relationship between the vendor and the sponsor and the common goals of success and stability. The sponsor needs to keep in mind that, even though it delegates vendor management to the CRO, it is ultimately them who are responsible for all regulatory obligations. The sponsor needs to manage costs thinking of all the pros and cons that could arise due to potential conflicts while choosing a vendor. The sponsor can go for a consultation option and should ask the vendor to present it with all real time costs of clinical trials.
One of the major problems faced during outsourcing of trials by sponsors is contract delay. We all know that time is a very important factor in clinical trials. But certain vendors, who are not experienced and handling the sponsor for the first time, will not have master files of agreement and this may delay the project. It therefore recommended for the sponsor to carefully compare and evaluate vendors before zeroing on the final vendor.
It is wise for the sponsor to choose a vendor who is experienced with different geographic locations and have their offices set in places where the sponsor is interested in conducting the trial. Likewise there are many such aspects which the sponsor needs to keep in mind while trying to outsource a clinical trial. This article is an attempt to introduce basic facts which comes in light during outsourcing.