Small biotechs and pharma companies have gained an increased percentage of the clinical research market over the last decade. While some experts may consider this growth a flash in the pan, a recent study conducted by McKinsey indicates otherwise;

“While large pharma companies are expected to grow R&D spending at a rate of 4 percent annually—to $234 billion for the industry in 2025—R&D spending in biotech is forecasted to grow twice as fast, at up to 8 percent per year”

Some biotech companies  might be smaller than an established legacy brand, but that doesn’t mean they have to accept poor quality service or excuses from their CRO. 

As R&D spending by small biotechs continues to rise, CROs are struggling to meet the requirements, maintain quality, and provide these clients the attention they need and deserve.

In this research paper, we highlight three of the most common problems small biotechs and pharmas face when working with traditional CROs and recommend a solution designed to help maintain quality and meet timelines. 

3 Reasons Small Biotechs Report Growing Dissatisfaction with Traditional CROs

Biotech startups have very specific needs. Needs that are fundamentally different from those of established pharmaceutical companies. This disconnect often leads to unfulfilled expectations and communication breakdowns. 

To make matters worse, most large CROs face high turnover. This rotating cycle of key personnel often leads to timeline disruptions, leaving small biotechs in a constant state of flux and lacking the highly specific expertise they need.

Reason #2: Quality is compromised

Quality Assurance is essential to the success of any clinical trial, but not everyone defines quality in the same terms. 

A longitudinal study conducted by The Avoca Group, found there are significant disconnects between expectations of quality and what it looks like to successfully deliver on those expectations.

Specifically, the study asked sponsors and CROs two questions regarding quality:

Sponsor question: “Overall, how satisfied are you with the ‘quality’ delivered by your CRO in the past 3 years?”

CRO question: “Overall, how satisfied have you been with the ‘quality’ that your company has delivered to sponsors over the past 3 years?”

Only 2% of sponsors reported being “very satisfied” while 28% of CRO’s reported the same. While the sponsor’s level of dissatisfaction was alarmingly low, the CRO’s account of their own performance was almost equally disconcerting, indicating a real issue when it comes to aligning expectations when it comes to quality. 

Clinical Leader notes that:

“The survey results were both interesting and disturbing, highlighting a significant opportunity to engage stakeholder organizations to network more closely on clarifying expectations for quality and refining processes for the successful delivery to these expectations.”

Factors that may exacerbate the sponsor’s dissatisfaction with the quality of service provided by CROs include:

• Unexpected charges

• Lack of timeliness in resolving issues

• Poor services and deliverables quality

Reason #3: Many biotechs feel their incentives are misaligned with their CROs

Given their size, some large CROs may move at a slow pace. Their reliance on traditional bureaucracy and drawn-out project timelines can cause serious headaches for smaller firms. 

Without the ability to pivot and change directions quickly, you may experience trial delays, ballooning costs, and other hiccups. 

Solution: A La Carte Services to Supplement the Areas of Concern and Manage the Process 

The industry is facing unprecedented challenges brought on by the pandemic, labor market, supply chain problems and inflation. This confluence of factors has triggered numerous obstacles for CROs in their attempt to meet the needs of small and emerging biotech and pharma companies.

With so much uncertainty, many decision-makers have come to expect excuses from their CROs, accepting poor quality work, missed timelines, and high attrition. 

As an industry, we must do better. No. More. Excuses.

The challenges that CROs are facing in meeting expectations are reportedly felt across the board, but have a particularly large impact on small and emerging biotechs. Harbor Clinical provides a solution that bridges the gap between sponsors and their CROs, ensuring ongoing quality while also maintaining business continuity. 

Harbor Clinical’s vendor oversight and Functionally Aligned Strategic Team (FAST™) will provide comprehensive oversight at the project and functional levels. Where weaknesses are identified, Harbor Clinical will assist the CRO through staff augmentation, ensuring that the sponsor’s deliverables are met on time without any sacrifice in quality or compliance.

To learn more about our Vendor Oversight and FAST service model email [email protected] or visit our website.