Choosing the right contract research organization (CRO) is one of the most important decisions you’ll make in your clinical trial. The best CROs are true partners, supporting your study at every stage and ensuring compliance.
In recent years, however, finding the right CRO has become more challenging as the landscape has evolved. The global CRO market is expected to grow to $64 billion in the next five years as new technology, big data, and a growing need to renew patents all increase demand.
Here are three significant changes that could impact your choice.
3 Ways The CRO Landscape Is Changing
1. Continuous consolidation
The growing quest by large companies to outsource more of their research and development tasks has prompted already large CROs to acquire niche companies to expand their capabilities. Private equity firms have also sought deals in this space.
In just the past ten years, for instance, we’ve seen mergers including:
- Private equity firm Jaguar Holding Company acquiring leading CRO PPD and other clinical service companies in 2011
- LabCorp acquiring Covance for $5.6 billion to create a leading healthcare diagnostics company
- Quintiles merging with IMS Health in 2016 to become IQVIA, the world’s largest pharma services provider with 50,000 employees, valued at $18 billion
- InVentive Health and INC research merging in 2017 to create one of the three largest CROs, with combined revenue of more than $32 billion
- Private equity firm Pamplona Capital Management acquiring Parexel, one of the leading CROs, in 2017
- Charles River Laboratories International acquiring biopharma and medical device CRO MPI Research for $800 million in 2018, then acquiring Citoxlab for $510 million in 2019
- Syneos Health, a biopharmaceutical CRO, acquiring clinical research home health services company Illingworth Research Group in 2020 to expand its focus on therapies for oncology, respiratory problems, and rare diseases
In deals like these, company leaders and investors have sought to gain a competitive edge by offering new services or repositioning their focus. However, these CRO mergers and acquisitions have in some cases diluted or overcomplicated the core mission, especially for CROs specifically focused on medical device research. In many cases, mergers result in overlapping functions, internal strife, and layoffs. This hurts employee morale and can contribute to increased turnover in an industry where it’s already higher than other industries. It can also lead to CROs relying more on outside vendors instead of in-house employees.
There are also significant differences between drug trials and device trials, including distinct phases and unique challenges. The focus on adding new areas of pharmaceutical research in some of these deals means they may not have the same therapeutic expertise medical device companies have come to expect from them.
2. Reduced competition and higher prices
The merger and acquisition activity has narrowed the field of available options in the CRO industry, giving a few very large companies greater market share. This lack of competition can lead to higher prices for drug and device sponsors.
Large CROs, especially those that have been acquired by private equity firms or are publicly traded, need to consider their stockholders as they set their prices. They can become more concerned about profit margins than helping sponsors stay within their budgets. As a result, sponsors may see increased fees for minor change orders or services that were once included. Processes can become highly standardized, with a one-size-fits-all pricing approach.
Unfortunately, this becomes a dilemma for sponsors looking for more affordability and flexibility. For instance, an orthopedics company may only need consulting on one specific part of their clinical trial, such as designing your monitoring protocol with a risk-based approach in mind.
A large CRO may be hesitant to dedicate resources to a smaller project like this.
See how to adapt to a changing landscape using a hybrid approach. Join us at 4 p.m. Tuesday, May 18, for a Device Talks Tuesday session with IMARC President Brandy Chittester.
3. The adoption of AI and new technologies
There are some positive changes impacting the CRO landscape, too. Many CROs are adopting new technologies to improve patient recruitment, clinical trial management, and data analysis.
A few examples include:
- Using artificial intelligence to match patients with trials more effectively
- Using predictive analytics to boost patient recruitment and retention
- Using AI to reduce uncertainty in pre-clinical experiments
- Using AI to detect inaccurate data in data management systems
- Using AI to streamline data collection and analysis
- Monitoring data for inconsistencies throughout clinical trials
- Using machine learning to help detect patient conditions
While these new technologies offer many benefits, there are additional factors to consider. For instance, ethical concerns may arise if AI is influencing decisions that could impact patient safety. There may also be concerns about bias, quality control, and accountability.
CROs should continue to embrace these new technologies as long as they do so while thinking critically and following the fundamentals of Good Clinical Practice at all times.
How To Find The Best CRO For Your Clinical Trial
A contract research organization (CRO) can add tremendous value to your trial by overseeing critical compliance elements and providing additional support with routine activities to keep your trial on track.
However, with so much changing in this industry, it’s important to find one that offers more than a familiar name or an impressive size.
First, look for a full-service contract research organization that can support you throughout the entire clinical trial lifecycle. Ask questions about their experience in your specific field, especially if you are in the medical device industry. Learn more about their process and what methods of communicating with you throughout the trial. Find out what global partnerships they have, especially if you plan to conduct studies in the European Union or in other countries.
Seek out references from other companies with projects that are similar to yours, and learn more about how the CRO you are considering helped them overcome challenges.
Finally, ask about their pricing structure and how they will help you stay within your budget.
As a full-service medical device CRO, IMARC has the resources to handle large clinical research projects while giving your team plenty of individualized attention. Our team becomes an extension of yours, supporting you at every stage in the process.
To learn more about what to look for when hiring a CRO, download this 20-question checklist.