The Aperio Blog

Four Things Every Small Biotech Should Look for in a CRO Partner

Cari KniolaDirector, Corporate Strategy
September 13, 2021

Small biotech companies are dominating innovation in the life sciences industry. In 2020, small and mid-sized pharma accounted for 72% of the new molecular entities (NME) approved by the US Food and Drug Administration (FDA). And 2021 is shaping up to show similar results.

Despite their success, small biotechs don’t always get the attention and support they need from the CROs running their trials. Historically, big pharma brings more money to CRO relationships, which means they tend to get more seasoned teams and executive attention.

That can be frustrating for smaller firms, especially if they are only developing a single compound. The success of these projects can make or break the business, which makes their milestones and deadlines strategically critical.

They need to know that their CRO cares about their project’s success as much as they do, and that their team understands the ultimate goals. While big pharma may be focused on regulatory approval and commercial success, small biotechs may have more near term milestones, like securing investment capital, selling the compound mid-development, or getting acquired.

These goals can impact the timeline and planning for a trial and require a CRO team who understands the unique challenges that small firms face in developing a new drug.

How to choose

When vetting CROs, along with validating their clinical expertise, small biotechs should look for research partners who can provide the following:

Consulting support. If the biotech’s team has limited experience planning and managing a trial, they should look for a CRO that will offer guidance and consulting as part of the partnership. That includes helping the biotech team set realistic timelines, enrollment goals and budgets, and to identify opportunities to accelerate progress and/or better manage resources.

They should review the entire trial journey together, to identify critical risk points related to recruiting, study start-up, and database locks, so they can plan accordingly. This early and ongoing support ensures the biotech team has the best strategy in place for success, and risk mitigation plans identified if early goals aren’t met.

Flexibility. Small biotech companies with limited resources need a CRO who is able to adapt the trial in response to their evolving needs. In these environments, every patient is crucial to the study, and every decision must be treated with a sense of urgency to deliver the best results.

For example, if early data suggests the study design needs to be revised, or if company priorities change and timelines need to be re-addressed, the CRO should be able to pivot quickly and offer guidance on the best way forward.

Individual attention. A big CRO has the resources and reach to support dozens of clients simultaneously, which can be a great asset for any life sciences company. However, it can also mean that smaller biotechs may not get the level of attention they need or may suffer from a one-size-fits-all approach to trial management.

Smaller CROs run a select number of trials at a time, allowing them to be more responsive to smaller clients. In these organizations, biotech leaders can expect to have an intimate, dedicated team with experience running trials for smaller organizations. These CRO teams use their experience to provide support and guidance to the biotech teams who might not have the bandwidth or internal background to understand the impact of individual study decisions on the big picture.

Global partners. One of the big concerns with small CROs is that they don’t have teams in every country to run global trials. While it is true that many small CROs are not multi-national companies, most of them have partners in other countries who can operate seamlessly with the home team, delivering the same quality and consistency. It’s a lean organizational model that ensures the CRO can provide a global research experience, with less added cost and overhead.

Choosing the right CRO is vital for ensuring you have the best support, guidance and experts on your team. Making sure a CRO will provide the expertise, flexibility, individualized attention and global reach will put you on the best path to success.

Cari Kniola

Director, Corporate Strategy

Cari’s role in Corporate Strategy includes oversight of marketing and proposals, and working with the C-Suite in developing and executing strategic corporate development and growth.

Cari has over 22 years of clinical research experience in both pharmaceutical and medical device studies. During her career she has served in various roles, including study coordinator, field based CRA, clinical trial manager and eight years in project management. Her operations experience included roles with sites, sponsors and CROs, and she understands the challenges that each face. For the last two years, Cari’s role has focused on the corporate side of clinical research, using her operations experience and business acumen to drive proposals, marketing and corporate strategies.

When not planning Aperio’s next move, Cari spends her free time strolling on the Lake Michigan shoreline, hiking in the Indiana Dunes and fulfilling her obsession with LEGOs.



Part 1 – Demystifying the Decentralized Trial. Read now. 


Part 2 – Demystifying the Decentralized Trial. Read now.