Recent news reports revealing that large CROs becoming Mega CROs created by recent mergers. Is that an irrevocable trend ? Is that the future of clinical research outsourcing?, What then will be the positioning of Mid-Sized CROs ?
According to recent surveys the top 5 capabilities Pharma & Biotech companies are looking for assigning a CRO are :
- therapeutic & regulatory expertise
- global footprint
- quality of CRAs
- upfront contingency planning
By their nature, the largest CROs try to cover all, claiming expertise in the full range of clinical trial operations from preclinical to post-approval as well as therapeutic and regulatory expertise in a wide range of areas. It is true just to assume that the larger CROs have the most talented work force ? Is it correct to make the conclusion that because one organization is bigger than another, it has the skills and capabilities to deliver faster with more success on larger projects than smaller companies ?
We are observing that more and more Pharma & Biotech companies questioning if these organizations can offer the same level of flexibility, specialisation, personal service and senior management involvement; often provided by smaller and mid-sized CROs. For example, smaller organizations are typically able to quickly assemble team members with the right experience to fit the specific requirements of a study and also be able to scale services up or down if needed. Regardless the fact that Co Creation is an important aspect of a mutually successful partnership. There where larger CROs can often find themselves governed by set processes and may be slow in response to change.
Investigators are starting to step out of their usual way of selection a CRO partner as well. While companies across the industry are continuously facing new, competitive, regulatory and economic challenges. Investigators are increasingly looking to use a CRO as an extension of their team in order to form a successful partnership. They are tending to select CRO partners with the vision of building a lasting, collaborative relationship having a strong understanding of the challenges they face. Having the ability to meet their unmet needs , to align with local expertise with a low turnover of CRAs.
Trending to a pivotal change ?
So, rather than sticking with the familiar way of selecting by automatically assigning new projects to an existing CRO partner based on previous study results or established relationships, Pharma and Biotech companies are starting to consider their options using the CRO best qualified for that particular trial. Outsourcing clinical research can present a unique type of challenges to any organization; it is both a challenge as well as a solution to other business opportunities.
Selecting the right CRO partner is it an art or a science ?
Unburdened of any necessity opting for Big or Small; both big CROs as midsized CROs united in a partnership or network are able to provide a global footprint needed for large studies as well as deep expertise in specific therapeutic areas or technologies. Because, ultimately, sponsors are investing in a project team to research a specific issue, there is no reason that a midsized CRO can’t partner with a large sponsor to execute key trials where the midsized CRO has its therapeutic expertise. Mid-Sized CROs are also more likely to work with the local affiliates of large pharma and mid to small size pharma companies than larger CROs which is offering more opportunities for Co-Creation.
One last critical element often overlooked by a sponsor in choosing an CRO is Cultural Fit. Cultural Fit between two organizations is the congruence of people, mission and trust that align the two organizations ways of doing business. A good cultural fit usually brings positive teamwork, good energy, rapid progress, trust and transparency and recurring business opportunities. A bad fit can bring just the opposite: distrust in motives, finger pointing, a lack of teamwork, unmotivated teams and slow progress. In fact, sponsors find they often have a smoother process and better outcomes by selecting a midsized or smaller CRO. They have the feeling of being rewarded as “Sponsor of choice”. A good cultural fit contribute in doing business together with trust, respect and a smile; being happy doing it.
The creation of our CRO network as strategic partnership of mid-sized CRO’s will not result in answers for all but will contribute hopefully to an increasingly unmet need of sponsors and investigators to address their unmet needs.
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