TECHNOLOGY & DATA MANAGEMENT
Picking the right sized partner can significantly affect the trajectory of a drug development program. Every sponsor has different needs and every CRO has different strengths and weaknesses. Most CROs strive to be all things to all sponsors. The reality is that they each have specific strengths and areas where they are not as strong as their competitors. Being able to accurately assess these strengths and aligning them with your company’s needs sets you up for more success in terms of positive vendor engagement, completion of required deliverables, and overall satisfaction with the work product provided. Conversely, selection of a CRO partner that is not aligned with your company’s priorities; with differences in the expectations around types and frequency of communication, resourcing availability, and level of team interaction, can create an adversarial relationship that is not conducive to timely completion of study goals. No ‘one size fits all’ solution exists when it
comes to resourcing. Smaller CROs are more often able to provide the type of high-level engagement and personalised team structure with a focus that is especially valued by many smaller biotechs, who often feel that their needs are deprioritised by larger CROs in favor of their larger clients. However, small CROs are often not able to provide the same level of global reach offered by their larger competitors. Nor can they compete with them in terms of the robustness of their tracking systems, report visualisations, and proprietary data sets. Additionally, large CROs are well known by regulatory authorities and tend to have a robust experience with the regulatory submission process in multiple markets. Larger CROs also tend to have a much higher
overhead cost that is added to the bottom line of their budgets. This limitation is also coupled with more structured models for providing discounts that are often not as flexible or robust as the ones offered by more boutique partners who have a small level of bureaucracy and often have more flexibility in the type and size of discounts, they can offer. However, selecting a CRO based on any one
factor, such as cost, alone would be a mistake. Although project managers are often incentivised to look for opportunities to keep costs as low as possible, over reliance on cost as
a final decision-making tool can have downstream impacts on timelines and quality of deliverables. Similarly using qualitative judgements such
as ‘good team fit’ as a sole decision-making criteria can lead to undesirable outcomes. It is critical to recognise that teams will change throughout the course of a project and the team one initially assesses will not usually be the same team at the end of the project. Additionally, assessments about team fit can be biased by a singular personality at a CRO that can mask deficiencies in other areas. The best practice for evaluating and selecting
a potential CRO partner should include multiple dimensions with a risk analysis of potential partners. The different decision-making factors should be weighted based on your company’s needs and a simple analysis performed to inform your decision. It is also important to recognise that regulators are increasingly interested in how CRO partners are assessed, selected, and managed with the expectation that companies should have documentation detailing how decisions were made. Some factors that should be considered in the selection process include: • Regulatory considerations: In which countries will the study or studies be run? Does the partner have experience with appropriate regulatory authorities in those countries?
• Size and scope of program: Does the CRO have the capacity to scale up as your program grows? Even if early phase studies will be limited to a single country, future studies may require international reach. This should be assessed during the selection process as it may impact both study quality and potential discounts based on work volume.
• Company culture and structure: Do the CRO’s values align with your company’s? Larger CROs tend to have a more transactional business model which can be appropriate for some pharma clients, especially larger pharma, which prioritise contractual obligations. Smaller CROs more often rely on less formal and flexible team structures and strive for high customer service to differentiate themselves. This model can be appropriate for biotechs that place emphasis on team building, relationships, and direct
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