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October 02, 2009

Strategic Partnerships vs. Contract Engagements: The Benefits of Collaborating with a small, personalized CRO

EmpiriStat’s recent attendance and exhibition at the 2009 PDA/FDA Joint Regulatory Conference reinforced one of the key reasons that our company was founded.  Companies, small and large, NEED organizationally small, efficient, and focused CROs like EmpiriStat, especially emerging biotech and pharma companies.  EmpiriStat has always stressed collaboration over contract and partnership over the traditional vendor/service relationship.

It is important to the success of a company entering the clinical stage to develop a close-relationship with a CRO. But it has always been a struggle for new firms to gain the kind of intimate and catered relationship that big pharma commands from CROs; Small Pharma becomes the quintessential ‘small fish in a big pond’. But EmpiriStat, which offers all the services of the big boys, can come in and work with small pharma as a valued partner, rather than the typical vendor/client relationship. 
 
Smaller firms and research sponsors tend to have more limited budgets, hence less resources for administrative, management, and technical functions. It is advantageous for the sponsor to capitalize on the capabilities of a CRO to organize, create, and administer complete clinical trials.  The design of a trial is paramount to the trial’s success. CROs, including small groups like EmpiriStat, have the experience and expertise to design trials that are more likely to efficiently achieve stated clinical, regulatory, and commercial objectives. 
 
Along with trial design, effective and well-executed Statistical planning and analysis is a vital part of any project or clinical trial, and EmpiriStat’s guidance of these technical aspects early in the planning phase ensures the quality of a firm’s results in the end.
 
Rather than offering line-item contracts, which automatically include (expensive) items small collaborators don’t typically need, EmpiriStat acts as a market-driven CRO, providing more focused and customized service. A smaller CRO like EmpiriStat by nature has the ability to tailor its services to the specific needs of the sponsor. The combination of visibility, personalization, and lower overhead distinguishes smaller CROs as market leaders, making them more attractive as emerging company sponsors place higher value on expertise and relevant skills, instead of focusing on capacity.
 
Creative CROs are more open and adaptable to solutions that cut costs and maximize efficiencies. These CROs are more likely to introduce new procedures, processes, and technologies, versus the large CROs that are too entrenched in their old styles and attention to volume. This is especially true of EmpiriStat, where we’ve adopted a technology platform that utilizes multiple data sources and largely eliminates the need for manual intervention. EmpiriStat, as a small privately held organization can also offer price reductions whereas large CROs have to focus on quarterly results.
 
Communication is important to any business relationship. And the rule that small business is more concerned about their client’s needs is especially true for CROs. With large CROs, there are typically so many layers of management, that simple decision making takes valuable time.  The most successful business relationship is one where there is a constant exchange of information, which emerges from trust, honesty, and open communication. 
 
EmpiriStat has worked with clients of all sizes from the Pharmaceutical, Academic, and Military communities, as well as other larger CROs looking for specialized services expedited in an efficient manner. While we proudly recognize the effective efforts made for all clients, EmpiriStat is most encouraged by the relationships we’ve been able to develop with the smaller groups. The success of forging ongoing relationships with experts who are dedicated on a personal level to the trial and project at hand, becomes evident in every collaboration. 
 
The advantages to these forged strategic partnerships aren’t solely those of the sponsor; the smaller CRO also benefits from the New Pharma/Small CRO relationship. These benefits often include:
  • Similar work ethic and philosophies. Emerging sponsors and small CROs share a similar entrepreneurial motivation. Both partners recognize the need to tightly manage cost and risk without tempering innovation and creativity. This mutual entrepreneurial spirit allows us to take chances and jointly engage the sponsor in ways that large CROs are either unable or unwilling to. 
  •  Navigating the lean times. Tough economic environments can take their toll on companies of all sizes, sponsors and CROs included. Long-term strategic alliances, versus contract engagements, provide stability to the smaller CRO, along with the advantage of investing in expertise and equipment that will enhance their overall services. Also here, the large CRO becomes a risk for its smaller client, in that they can’t adapt quickly and the sponsor is locked into a long-term contract.
  • More learning opportunities. As with any CRO, every client/partner may be an educational experience rather than just repeating established tests and trials. But whereas the large CRO is dismissive of the chance to learn from and adapt to these experiences, the small CRO capitalizes on the opportunity to discover new efficiencies, methodologies, and capabilities, leading to a work environment that is consistently challenging, interesting and relevant. While EmpiriStat prides itself on staffing field experts, we realize that learning opportunities never cease, regardless of how much experience a person has already gained.
Collaboration between new pharma and small CRO provides multiple benefits and considerably less risk for both partners, not to mention the fostering of a long-term partnership enabling both firms to grow.
 
In summary, a new, emerging company might still be a “small fish in the big pond,” but at least with a collaborator like EmpiriStat, they’ll have a dedicated, efficient, and extremely capable partner by their side.



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