From Vendor to Partner: The Path to Selecting an Equally Devoted CRO
The most competitive contract research organizations (CROs) are suited up to stand out as business partners — not vendors. In the past, taking a product to market required drug developers to find a CRO that checked the boxes and did a job. Today, it’s about finding a partner that is equally invested in the outcome of the clinical trial.
How can you tell whether the CRO operates as a vendor or a partner? Simply put, a vendor does a job; a partner is invested for a lifetime.
In a technological world in which consumers and employers can cherry-pick from the best, the same goes for pharmaceutical companies seeking a CRO. It’s imperative to know what to look for in a rapidly changing climate.
Drug developers ready to shift from a CRO vendor to a partner should leverage the following tips in their search.
The Competitive Landscape Heats Up
This change in approach to the CRO relationship is the result of a highly competitive landscape. Biotech growth over the past decade has skyrocketed, alongside growing drug development. Pharmaceutical market data shows that in 2021 alone, 18,582 drugs appeared in the pipeline — nearly double than in 2011, when the number was a mere 9,713. Registered clinical trials rose from 118,023 in 2011 to 399,531 in 2021.
The growth in biotech is being noted around the globe with average share prices for biotechs increasing by 106% in China, 39% in Europe and 37% in the U.S. between January 2020 and January 2021. Investors are highly attuned to these changes, as the S&P 500 has risen 17% in this market. The financial support speaks for itself with 600% more venture investment and $30 billion in venture capital funding.
More drug approvals have followed. Between 2017 and 2021, the U.S. Food and Drug Administration approved on average 52 novel drugs per year — a double-digit jump from the 22 drugs approved per year, on average, from 2010 to 2016.
With this many players on the field, a sponsor’s project requires an equally invested co-owner in order to ensure prioritization of the clinical trial and assets that provide a competitive edge over others on the market.
A Strategy for Finding the Best Partnership
When looking for a CRO, a strategic approach will yield the best results. As biotech and pharmaceutical teams interview CROs, it’s important to seek out organizations with modern capabilities in technology, governance and leadership. Some key qualities to look for are:
- A technological infrastructure and modern processes, including a platform that integrates clinical and laboratory data in near-real time and modern site contracting tools.
- A leveraged partnership model with shared governance. For instance, an operations leader at a top biopharma company was looking for a strong CRO partnership for a global Phase III trial that was facing significant recruitment challenges and delays. Our experts worked closely with the biotech company to delve into the metastatic breast cancer study — already underway before the partnership was formed. The partnership with PPD enabled the transformation of the pre-screening database and other enhancements to the overall patient experience, which got the study back on track.
- A CRO that’s actively investing in its people. Companies that prioritize education and employee well-being have the best talent on hand for your trial.
Clarifying The Shift in Approach to Your Team
Change is uncomfortable for many teams and organizations — even moves that can drive better return on investment (ROI). Leaders should prepare to answer questions about the benefits of shifting from a CRO vendor to a partner. To emphasize the benefits of this evolution to your team, consider these differences:
|3-6 month engagement runway
|6-12-month engagement runway
|Financial/operational incongruity (business value gaps)
|Business and values alignment
|Oversight viewed as administrative burden
|Governance and executive oversight — as well as a support-led model
|Client holds risks
|CRO shares risk
|Staff motivation challenges (high turnover)
|Magnet for talent — a more dedicated and seasoned staff
|CRO selection is high burden
|CRO selection is low burden
The Importance of a Thoughtful Vetting Process
In any vetting process, the right questions can quickly streamline identification of the top contenders or uncover potential mismatched values. When pursuing a CRO partner, the following questions can help distinguish if a potential candidate is a seamless match.
- Experience: Who from your last successful study in our indication is still with your organization?
- Strategy: You know our plans for our brand and our asset(s). How do you plan to strategically support these?
- Timeline: What is going on in our treatment landscape, and how can we be the most attractive study to sites?
- Team: What specific skill set does your team have that makes you uniquely suited to manage this study/portfolio?
Tips for Success in Selecting a CRO Partner
Choosing a CRO can be a lengthy process. One of the first steps for a biotech or pharmaceutical firm is to establish its wants and non-negotiables before engaging with potential partners. Here are a few additional approaches to streamline the process.
- Narrow your search: Narrow the key wants and needs from a partnering CRO and continually reflect on those specifications.
- Know the commercial terms: Discount? CRO “skin in the game”? Fixed price? What best suits your organization?
- Be transparent about your preferred culture: This helps the CRO understand how you prefer to work and enables them to match you with the right team.
- Decouple a request for information from a request for a proposal: CROs have a lot of information to share with customers. This will help make it meaningful and consumable.
- Align internal stakeholders: Upfront alignment and clarity around priorities avoids harmful roadblocks in the selection process.
- Tell the CRO what keeps you up at night: If your development partner knows your priorities and what concerns you most, they should orient to it in solidarity and support.
Evaluating whether your CRO is going to be an invested business partner — and not just a vendor that delivers a study — will be something that rewards your team for years to come.
Every change comes with its benefits, and the partnership approach to a CRO isn’t lacking. Reframing your search — so that you’re researching, vetting and interviewing CROs to determine who’s going to be an equally invested partner — may take longer than previously anticipated, but the reward of succeeding is worthy of the extra time spent.
The partnership with a CRO is a two-way street. Whether it be professional or personal, every partnership is a commitment with benefits that keep the parties continuously engaged. The return on a seasoned team that is invested in the outcome of your product — especially when considering the competition — is priceless.
Learn more about how a CRO accelerates clinical development and four key factors to consider when selecting a CRO partner.