Outsourcing as a business practice has been around for centuries and some economists would argue it has been around since man first started providing services to one another. The concept is based on the premise that a specialist company that focuses on a specific functional area can do a better job faster, and at less cost, than a generalist approach whereby you employ all functional areas needed internally. The practice has become entrenched in many areas of industry including the Pharmaceutical and Biotech industry and has fuelled a boom in companies carrying the acronym CRO (Clinical Research Organization).
Establishing robust metrics at the start of a study, and systems to monitor them in an ongoing manner, should be integral to all work that a Clinical Research Organisation (CRO) performs. There is an expectation from clients that metrics will be used to monitor progress or lack of progress, including deviations from the planned schedule. However, these metrics are sometimes not defined clearly at the outset and often not incorporated into clinical trial contracts. A lot of metrics need to be “balanced” between what is controllable by the CRO and what is controllable by the sponsor. Therefore, the metrics that are incorporated into a contract need to be carefully chosen. Ideally it should be a small and accurate set of performance metrics that will meet the customer’s needs and enforce efficient information flow – it being a breach of contract not to provide and review the metrics.
If a pharmaceutical, biotech or medical device company outsources its clinical trials, it may be neither practical nor advisable to use one single Clinical Research Organization (CRO). Smaller CROs may not have the infrastructure to deliver large multinational trials, and large CROs may not offer the level of attention or flexibility required for smaller, but no less important, clinical studies. However, whilst the choice of CRO may be study dependent for the clinical aspects (such as patient recruitment, monitoring, clinical project management and regulatory expertise) there are tangible advantages to centralizing all data handling activities with a single provider – one that supports clinical data management, biostatistics, pharmacovigilance and medical writing services.
Selecting the right Clinical Research Organization (CRO) is vital to the success of any clinical study. Get it right and the months that follow will be that much more enjoyable because the study is more likely to run smoothly and stay within budget. Those sponsors who have had to transition a clinical study away from a poorly performing CRO to an alternative supplier, mid-study, will be acutely aware of the pain that this can cause and the need for a thorough vendor selection process. The Request For Proposal (RFP) is a vital component of that process. A well-defined and comprehensive RFP creates the best chance of selecting the most appropriate CRO, or combination of CROs, to complete the project.
How can the efficiency of a Clinical Research Organization (CRO) be understood? As CROs provide various services to study sponsors, their overall efficiency at providing these services and internal processes to allow these to be delivered can be broken down into a number of elements with their own unique efficiency.
The third blog post in our “How Total Value Ownership (TVO) can help shape an outsourcing strategy" blog series.
location of staff within a functional partnership in clinical development was discussed in a previous blog, but this is closely linked to the experience of staff and where the different levels of experience reside. Having a solution primarily focused around graduates in a low cost area vs. a solution based around experienced team members in a higher cost location can have significant impacts on the cost of clinical development projects. It is likely that any proposed solution will incorporate both sides and understanding the exact make-up of the team will provide some insight into what the
Total Value Ownership (TVO) is likely to end up being.
The second blog post in our “How Total Value Ownership (TVO) can help shape an outsourcing strategy" blog series.
Project costs in clinical development partnerships can be influenced significantly by the location of staff since salary levels differ widely depending on where the staff members are located. The percentage and mix of staff in different locations can provide a cost-effective solution, but it can also provide a solution that compromises quality if the mix is not right. Whilst the initial costs may decrease and help to build a business case, the Total Value Ownership (TVO) may not look so attractive when taking into account the oversight and other costs associated with the deliverables. Any projects that move off their critical paths can also have significant impacts to the overall TVO, particularly if this results in delays of submissions and ultimately launch.
We've all heard the hype - Big Data will solve all your storage, processing and analytic problems effortlessly! Some moving beyond the buzzwords find things really do work well, but others rapidly run into issues. The difference usually isn't the technologies or the vendors per-se, but their appropriateness to the requirements, which aren't always clear up-front.
Big Data, and the related area of NoSQL, are actually a broad range of technologies, solutions and approaches, with varying levels of overlap. Sadly it's not just enough to pick "a" Big Data solution, it needs to be the right one for your requirements. In this talk, we'll first do a whistle-stop tour of the different broad areas and approaches of the Big Data space. Then, we'll look at how Quanticate selected and built our Big Data platform for clinical data, driven by the needs and requirements. We won't tell you what Big Data platform you yourself need, but instead try to help you with the questions you need to answer to derive your own requirements and approach, from which your successful Big Data in clinical trials solution can emerge!
The first blog post in our “How Total Value Ownership (TVO) can help shape an outsourcing strategy" blog series.
Total Value Ownership (TVO) is not a new concept but it is an area that has attracted much interest in recent years. It can help in determining the best approaches to take and suppliers to use, by demonstrating the real value of selecting a certain partner in clinical development.
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