Why Emerging Pharmas and CROs Need Each Other

Strategic relationships with CROs have typically been the exclusive domain of large biotechnology and pharmaceutical firms with multi-millions to spend on clinical trials. However, the face of the biopharm world is being altered by smaller firms, and the strategic relationships between the small- to mid-sized biopharmaceutical company have taken a new form. Now, growing biopharm companies are working with specialized CROs for gains in efficiency and cost effectiveness.

Rather than being the small fish in a big pond, emerging firms are actively elevating their status by testing the waters of strategic partnerships with their CRO. Many of the benefits of working with a CRO that accrue to larger organizations are even more important for the smaller research sponsor that likely has limited resources. These resources include:

• Capitalizing on the capabilities of a CRO allows sponsors to focus on their own core strengths rather than organize, create, and administer a complete clinical trial themselves.

• Optimally designed trials that are conducted correctly the first time are crucial for success. CROs have the expertise to design trials that achieve stated clinical, regulatory, and commercial objectives in a focused manner.

However, it may be difficult for an emerging firm to elicit the level of attention needed from a large CRO to achieve these benefits.

At Clinipace, we have been successfully exploring the full range of a strategic relationship with Inspire Pharmaceuticals, a biopharmaceutical company focused on developing and commercializing prescription products for ophthalmic and pulmonary diseases.

With one or two drugs, Inspire was able to work directly with investigative sites to manage clinical trials. Generally, the company had been reluctant to outsource the management of studies. Inspire felt that it was good at developing relationships with investigators and had worked hard to build and maintain those relationships. They felt that inserting a big CRO into the mix would dilute the relationship with those sites.

But as Inspire's portfolio grew, the company began to realize that time spent managing trials was time taken from development and other core competencies. While the company had worked with larger CROs in the past, Inspire felt the time was right to be more strategically engaged with its CRO partners.

Forging a new paradigm

Inspire had previously deployed Clinipace's technology-based research software solutions and thus had established a good working relationship with its executive team. Chad Ice, Senior Director of Clinical Research at Inspire, has significant experience working with large CROs, and he knew the particular aspects and dynamics of those relationships that worked, and those that didn't. In this case, lessons learned from the strategic working relationship between Inspire and Clinipace ran along several important themes.

Focus and customer service. Larger CROs tend to offer line item services that get added to every contract, even when they might not be the best fit for a smaller customer or project. As a result, a smaller research sponsor may be paying for services that they don't need, or bearing a disproportionate overhead burden. A smaller CRO has the ability to tailor its services to the specific needs of the sponsor. This has the added benefit of building trust since the sponsor doesn't feel nickel-and-dimed with line items.

Site relationships. One crucial element in driving a successful study is focusing on the importance of building and maintaining strong working relationships between experienced site monitors and the sponsor team. Clinical staff should serve as technology advocates, acting as extensions of the sponsor's staff, actively participating in team meetings and decisions.

Flexibility. Usually, a project with a larger CRO is based on strict adherence to an agreed upon scope of work. Anything outside that scope must be negotiated and submitted in a contract addendum. Smaller CROs have the flexibility to make changes without calling in the contract professionals and lawyers. Small tweaks to deliverables and deadlines can be made by mutual agreement among team members based on real-time information.

Communication. Successful business relationships often hinge on transparent information exchange and successful personal relationships—the kind that come from trust, honesty, and open communication. Trial visibility and two-way communication at the highest level aren't always possible with a larger CRO where there are too many layers of managers to navigate. Responsiveness at the top also goes a long way toward avoiding problems and mitigating risk.

Efficiencies. Rather than depend on volume for efficiency gains, smaller CROs seek innovative new technologies and processes that often can't be introduced into larger CROs with entrenched procedures. For example, our technology platform brought together multiple sources of data that would have otherwise needed manual intervention. And, because smaller CROs tend to be private companies they don't have to focus on quarterly results, but can instead offer price reductions.

According to Ice, "We especially like having the ability to communicate directly with senior members of the Clinipace team. It is important to us that we are important to them. As much as we value open communication, trial visibility is equally important as many program decisions must be made internally."

Much as this sounds like it all benefits the sponsor, the smaller CRO has a lot to gain from forging strategic partnerships as well. Some key benefits to the CRO include:

• Increased learning opportunities. For all CROs, each engagement is a learning experience rather than just a repetition of established tests and trials, but larger CROs are less likely to operationalize these experiences in their standard operating procedures. Discovering new efficiencies, methodologies, and capabilities can lead to an improved work environment that could promote staff retention.

• Shared appreciation of the entrepreneurial spirit. CROs and their sponsors enjoy a shared entrepreneurial spirit. Both understand the need to tightly manage cost and risk without constraining innovation and creativity. This allows the CRO to push some limits and engage the sponsor in ways that a larger CRO or sponsor couldn't.

• Stability in tough economic times. Strategic alliances are likely to be longer term than contract engagements. A longer term commitment from a sponsor provides the smaller CRO with stability and the ability to make investments in expertise or equipment that will enhance their overall service offerings.

Tips for moving ahead

As relationships among sponsors and CROs of all sizes change from contract to collaboration, smaller CROs can distinguish themselves by becoming market leaders. The combination of visibility, personalization, and lower overhead will make the CROs more attractive as emerging company sponsors place higher value on skills and operational expertise, not just capacity.

For any biopharm firms considering this kind of relationship, the following tips may help develop that type of partnership:

• Don't be afraid to ask for what you want—your CRO should be willing and able to accommodate requests.

• Be open to exploring new ideas that may enhance efficiencies and improve your business processes.

• Be willing to negotiate on schedule and deliverables as new or unexpected situations arise.

• Participate in team building activities or other opportunities to engage staff from both companies.

And finally, keep the channels of communication open, flowing, and respectful.

David Levin is Vice President at Clinipace, 3800 Paramount Parkway, Suite 100, Morrisville, NC 27560, email: [email protected].

Editor's Note: This article originally appeared as an Online Extra at appliedclinicaltrialsonline.com.