Outsourcing in Clinical Operations
Necessity of Outsourcing
The drug development is a highly complex and time-consuming process. This puts restrictions on the Sponsor in dealing with the increased workload adequately. In clinical operations, the Sponsor may require outsourcing services for different purposes such as to reduce waste, cut the cost, and reduce timelines. Thus, Sponsor seeks Vendors to outsource some of their work which eases the burden on the Sponsor. By outsourcing, the Sponsor can handle work pressure efficiently due to the increased number of personnel. This enables them to achieve their goals faster and helps them to fast-track the drug developmental process. The Vendors provide highly knowledgeable and experienced personnel, who have a vast experience in their respective fields, enabling them to perform the field associated tasks with better outputs in a shorter time. Use of third party Vendors also enables the Sponsor to increase compliance with the various guidelines which further increases efficiency and introduces better resource management.
Selection of Right Vendor and Strategy to Achieve the Goal
Successful outsourcing to the third party Vendors may take some time but can provide significant long-term benefits. Before outsourcing the work, the Sponsor must identify the right Vendors by analyzing their levels of experience, their capacity, technical capability, project handling strengths, and weaknesses, etc. A selected Vendor must comply with the Company’s business strategy and should demonstrate their commitment by signing the Master Service Agreement. There should be a Statement of Work clarifying the activities conducted, project deliverables, and business requirements. Proper governance of the Vendor is required to achieve the target on time and to get faster approvals. Transparency and coordination are required between the Vendor and the Sponsor to ensure the right outputs. Regular meeting on work update is required to ensure that everything is according to the timelines. There should be proper documentation of each task to make the work track process easy. In addition to this, the Vendor should have a defined point of contact in the Sponsor Company to resolve queries as soon as possible or to discuss upcoming plans.
Some Vendors may provide the Sponsor with a variety of services ranging from study conductance to regulatory services. In this case, the Sponsor may hire a single Vendor for a variety of tasks which help to save capital, and the efforts to find new Vendors again and again. Right Vendors have a better knowledge of current practices and regulations making them more ideal for outsourcing. Thereby, with the outsourcing of tasks to a third party service Vendor, a Sponsor can benefit in significant ways and also hasten the drug development process.