Early Engagement with a CRO Partner: A Game Changer for Emerging Biotechs

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The high-stakes world of small and emerging biotechs is extremely competitive. Transforming a clinical product from ideation to market demands significant resources and deep expertise to efficiently manage and enable success, especially in today’s landscape. Without this expertise, hurdles such as regulatory setbacks, protocol changes and wasted resources frequently arise. Additionally, small- and medium-sized biotechs often face challenges fueled by limited resources, small staff numbers, funding fears and a lack of in-house knowledge to navigate the regulatory process. These challenges necessitate a careful and optimized use of time and money. One of the most effective paths forward is forming strategic partnerships with external experts.

Many emerging biotechs have achieved success by engaging with a contract research organization (CRO) partner early in the process. In fact, those that did so at the onset of the COVID-19 pandemic brought their clinical products to market faster than their industry counterparts. Early engagement with a CRO partner opens doors to new opportunities, streamlines processes and strengthens investor confidence, especially when that partner has deep expertise, a breadth of resources and the drive required to make it happen.

Benefits of early engagement with a CRO partner

For biotechs, one of the best ways to ensure success in optimizing timelines and resources is by tapping into the best expertise. The right CRO partner makes this possible. Working with a CRO service provider propels the trial forward, as on-hand experts guide each step of the development and approval process, streamlining almost every aspect from end-to-end. Furthermore, when engaging with a CRO partner, the earlier in the process, the better.

When a biotech company engages an adept CRO partner from the beginning, they are better positioned to build the foundations needed to succeed in the following areas:

1. Proactive planning and risk mitigation

Setting a clinical development project on the right track from the outset is pivotal for biotechs with limited resources. It maximizes success by avoiding missteps and employing a team with the depth and breadth of knowledge needed to make the project successful the first time. Without proactive, skilled planning at the beginning of a project, it is difficult to prevent costly protocol amendments and time-intensive U-turns later in the development process. Teams that build efficiency into the foundational aspects of a project — without cutting corners — establish the necessary momentum to get the product to market faster and with more agility.

2. Regulatory support

Navigating the intricate regulatory requirements of the U.S. Food and Drug Administration, European Medicines Agency and other global regulatory bodies is one of the most complex aspects of bringing a clinical product to market. The right CRO partner should have a long-standing record of success with these regulatory agencies, providing sponsors with the experience required to avoid costly mistakes. Engaging with a CRO early in the process further reduces the risks of regulatory surprises and ensures compliance throughout the development journey.

3. Clinical trial design

The best trial design maximizes the success of a sponsor’s clinical trial while optimizing timelines and streamlining resource usage. To accomplish these efficiencies, the design must be fit-for-purpose. The right CRO partner will design each aspect of the trial to the sponsor’s objectives, optimizing protocol feasibility and setting stretch goals in a way that propels the process to the finish line with as few hiccups as possible. The earlier a biotech brings on their CRO partner, the more time they have to get to know the project’s needs, understand the goals and limitations of the team, and gather the building blocks needed to build the most efficient systems possible.

4. Data management and analysis

Difficulties surrounding data management and analysis are increasingly common hurdles for small biotech companies. It is essential to have the necessary capabilities to build robust data management systems. Accurate and timely analysis is crucial to avoid resource and timeline setbacks. However, it is challenging for a small company to manage this on its own. Engaging in a strategic partnership with an experienced CRO from the start of the project allows for customized data management and analysis workflows tailored to the biotech company’s specific goals, workflows and data needs. This strategic approach goes beyond transactional engagements, fostering a deeper understanding of the biotech’s protocols and objectives over time. Additionally, when these partnerships are long-term collaborations, they yield consistency and innovation by ensuring continuity, improvements in data quality and consistent handling. This reduces onboarding time for new projects and enhances the overall efficiency and effectiveness of the clinical development process.

5. Team integration

Two of the most defining aspects of a small biotech company are its people and culture. Emerging companies are made up of employees and founders with a shared vision and passion for creating new clinical products that ease the suffering and pain of patients in need. The last thing these organizations need is to bring on a contractor that does not share their mindset. The best CRO partner will strategically and effectively expand the company’s headcount, providing access to industry experts, streamlined communication and collaborative systems, all while adopting the sponsor’s culture and matching their vision. They will balance hands-on and hands-off approaches in a way that complements the existing working style of the company but also possess the insight to adapt when needed — all while pushing the project forward.

Building a strong, trust-based partnership

The importance of a CRO partner that is devoted to the success of a sponsor’s asset cannot be understated. The most effective partners will provide:

• Agility and flexibility: The clinical trial process requires deep expertise at each step and the ability to create a well-informed, robust plan. However, even the best-laid plans need flexibility along the way. CRO partners must have the know-how to adjust as new information arises and keep the project moving forward, even when things don’t go exactly as planned.
• Shared goals and passion: When a CRO aligns with a biotech company’s goals and a deep dedication to optimized outcomes, it creates the foundation needed to advance a product to market. This mindset is essential for efficient partnerships that optimize return on investment.
• Trust and integration: To have the most effective collaboration, a CRO partner should seamlessly integrate into a sponsor’s team. They should feel like an extension of an existing team, with everyone of one mind, paving the most effective path toward ideal outcomes.

PPD Biotech solutions: A CRO partner that shares your passion and vision

When partnering with a provider of CRO services, the earlier the engagement, the better the outcomes. A CRO partner that has end-to-end services, providing deep expertise at every possible step, is the best way to build a foundation for success for a small- to medium-sized biotech company. The PPD™ clinical research business of Thermo Fisher Scientific has been dedicated to the success of emerging biotechs for decades, directly demonstrating our capabilities in the biotech industry. With our deep expertise, long track record of success and agile nature, we bring the benefits of our scale while still adapting to the unique needs of biotechs. We know this mindset because we have been using it for decades.

PPD™ Biotech services elevate outcomes, streamline operations, support scalability and enhance quality, enabling biotechs to offload time-consuming details and stay focused on their vision. With access to global Thermo Fisher resources, we provide support across every element of the clinical development process. Our teams are dedicated to proactive planning, adept risk mitigation and comprehensive support from the earliest stages of the project all the way to market.