29 Jun WHAT IS A CRO AND HOW WILL MAKE YOUR CLINICAL STUDY EASIER?
What is a Contract Research Organisation and how will it make your international Clinical Study easier?
A Contract Research Organisation (CRO) is a company that provides support to pharmaceutical, biotechnology and medical device industries through the provision of Clinical Study services outsourced on a contract basis.
There are many advantages to untilising the services of CROs. The primary reason for outsourcing Clinical Studies is the Sponsor has limited internal resources. The resources required to run Clinical Studies are extensive. Working with a CRO means Sponsors avoid having to spend capital on staff and equipment that they may not already have in place. Sponsor companies can rely on CROs as they already have the necessary infrastructure.
Time is always of the essence with running Clinical Studies. Utilising CROs saves Sponsors time. Setting up a Clinical Study is a complex exercise and CROs have the expertise and know-how to navigate the ethics, regulatory and legal requirements, thus expediting the Clinical Study process.
CROs assist with project planning and part of this planning process involves putting together a detailed study budget. This provides sponsors with the expected duration and cost estimate for their Clinical Study.
Many CROs have global reach which means Clinical Studies can be placed in multiple countries. This is important because many countries require the Sponsor to conduct the Clinical Study in that country if they intend to submit a marketing application.
One of the key factors of consideration in the selection of a CRO, is the experience of that CRO in your portfolio. Prior experience allows the CRO to leverage existing relationships with experts in specific therapeutic fields giving access to sites and patients, which in turn facilitates patient recruitment, one of the key stumbling blocks to the success of Clinical Studies.
One of the disadvantages of outsourcing Clinical Studies to CROs, is that the duties can be delegated, but how can the Sponsor be assured that they are being completed properly? It is for this reason that most important factor for the success of a Sponsor’s Clinical Study, is a collaborative partnership with the CRO. Engage with a CRO team who feel a responsibility of ownership for the Sponsor’s Clinical Study. This is one of the key advantages provided by the small to medium size CROs that support the niche market of the biotechnology industry.
The AICROS network has international reach and provides Sponsors with access to small to medium size CROs. These CROs are as invested in the success of the Clinical Studies they support, as their Sponsors.