As with many industries, there has been a great deal of change in the contract research space since our company was founded 40 years ago. In the past, large pharmaceutical companies chartered their own path through small molecule development, with dedicated internal R&D teams around the world. That environment has changed and in just the last few years our field has skyrocketed, as businesses look to streamline activities, FDA regulations tighten, and drug development becomes ever more complex.

Many small to mid-sized companies now embark upon an outsourcing journey with a range of expectations and priorities that aren’t met by their CRO partner. Similarly, large pharmaceutical companies may run into roadblocks, before finding a long-term fit.

Equipment and facilities are important, but it’s often the intangible qualities that determine a project’s success. Below, we offer some tips on how to seek out the best possible CRO-Sponsor relationship. It’s not a mathematical equation; it’s about finding a cultural, resource-efficient match. Along the way, we hope to help you avoid some common industry hazards.

First Engagement
How do you find a hands-on and conscientious partner? Start by talking to your peers (or colleagues with outside experience), to determine which companies have a solid reputation. When you approach those candidates begin screening based on these important qualities:

• High scientific involvement. From day one you need to have the buy-in of a CRO’s leading scientists. At the end of the day, they are the ones that will be executing your projects. If a company truly values your work, experts at various levels will be made available, including the study director as you finalize negotiations.
• Customization. You’re not buying an off-the-shelf product, so look for a company that is prepared to listen and adapt to your study needs.
• Communication. It’s an important customer service measure. How open is the dialogue with your team? Equally important is internal cohesion and integration. How well do the different divisions/experts on their side communicate and share protocol and best practices? Many minds are greater than one.
• Geography. Related to communication, is the issue of location. CRO industries in regions such as China and India remain strong, but may involve a number of communication barriers. This may not be an issue for your team if the project is routine and well understood on your side. If there are potential variables or unknowns, think about the accessibility of the CRO provider throughout—do they have facilities in different regions and are their personnel near you?

Finally, ask how the company deals with unforeseen challenges. Are you going to get a mayday call, or a proactive heads up? Ideally the CRO’s various experts will come together to troubleshoot on your behalf.

Bigger Isn’t Always Better
Companies look to a CRO for their specialization. But the meaning of that goes far beyond types of studies or molecules. Many large CROs have evolved to deal with high volumes of repetitive, clearly prescribed work from large pharmaceutical companies. That’s great if you have a defined project. If you’re a smaller company however, that service may have specialized away from your core needs.

To find the right fit, ask yourself whether the transaction is about capital and resources, or co-opting expertise and a holistic service.

‘Classic’ large pharmaceutical projects typically involve:

• High volumes
• Pre-prepared study designs
• A hands-off approach
• The sponsor has staff and expertise in place to handle the results

Does this model resonate? Or would you benefit from:

• Protocol and study design
• Project advice and customization
• Ongoing communication and troubleshooting
• Training and resource advice
• An extra set of eyes, to ensure all regulatory standards are met

One further consideration in this space is how well both teams’ resources will be utilized. Is your small study being run on high-throughput equipment? If so, are you paying for the high capacity potential? It’s all relative and may change if your process scales.
Finally, determine if that end-stage chain link is strong – the one that translates a CROs findings into actionable data for your team. What sort of results are you going to be passed? Is there necessary support in place if you are small company that requires bioinformatics, medical writing or data management advice?

The Study Director is Key
The study director is arguably the most important person in your CRO-sponsor relationship. Behind all successfully outsourced projects are talented and conscientious leaders. Once again, finding a suitable cultural fit is important. They also need to be involved from the beginning, so you can assess them and they can get a running start.

In the modern CRO landscape, consistently achieving aggressive regulatory submission milestones with complex programs of work has become the norm rather than the exception. The interdisciplinary scientific coordination this requires has created new opportunities and challenges for the study director role. For success, they have had to advance their drug development savvy and cross-functional know-how.

Study directors are the key link between client and CRO. They are also viewed as the scientific focal point for regulatory authorities and are responsible for delivering study results that meet stringent GLP standards. To do so, they need to be ‘get it done’ leaders who are effective at managing personnel, timelines, study design, protocol and delivery of results. Above all they need to be effective project managers and communicators.

Interdisciplinary Programs – ‘Co-ordination Competence’
Outsourcing programs of work has added new challenges to managing CRO partners. Client expectations have risen considerably as they aggressively target submission deadlines for their precious development assets. While in the past, work was outsourced on a study-by-study basis, in today’s R&D environment companies increasingly look for complete programs of work, targeting a specific regulatory deadline. Some examples include investigational new drug (IND) enabling packages, or even complete development packages that incorporate chronic toxicity studies.

You may be attracted to a CRO for their established expertise in toxicology, ADME or bioanalytical chemistry. But, chances are, you’ll have a diverse set of needs throughout your research and development pipeline. Keenly investigate how these needs are going to be coordinated by the CRO and ask what mechanisms they have in place to ensure reliable achievement of interdisciplinary project plan milestones. The collaboration component of study directors (both scientifically and logistically) within an overall program is now essential to satisfy client needs.

Such programs are only as good as their weakest link. It is therefore highly important to probe for study director fit for each of the disciplines in the package. Also be sure to pressure test the CRO’s ‘coordination competencies.’ The core ability of a CRO to integrate multidisciplinary scientific workstreams into a coherent program delivered to tight submission deadlines has become the real benchmark of a competent CRO partner.

Of course, it takes two to tango! Achieving complex on-time deliverables requires both parties to be working closely together with joint ownership of program goals. Your chosen CRO partner must become an extension of your team, far away from the traditional supplier/customer paradigm. This can only be achieved by finding a true sense of ownership in the CRO mindset. Look for a CRO that demonstrates empathy at all levels, with evidence that shows your project will become their project and not a simply a set of tasks to perform. Finally, don’t hesitate to devote time to visit CRO sites and be exposed to as many staff at possible. By doing so, you’ll develop a clearer picture of a CRO’s key people and the values that they will bring to your outsourced project. 

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Alan Findlater is chief commercial officer at WIL Research.