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Your Clinical Trial Deserves TLC From PRC

Five Things To Expect (or Ask!) From Your CRO

November 11, 2016

Tony Taricco co-founded PRC Clinical in 2003. As the President and Chief Operating Officer, he is responsible for the general business operations and finance activities, as well as human resources, and clinical payment services. Tony spent 20 years in Workers Compensation Insurance, starting as a Claims Adjustor for a small company of 25 employees and growing with that company to the position of Vice President and a staff of nearly 300. Tony’s business degree and extensive practical experience in business growth brings together the unique perspective of understanding the values and challenges of a small business and molding those into a strong foundation for long term expansion.

1. Customer-centric: A project team built around your project, not the opposite.
2. Direct access to experts: Key Opinion Leaders (KOLs) for your clinical sites to support your study, as well as experienced team members and transparency with each person’s role.
3. Functional Service Model: What is it? How to set it up and benefit from it?
4. Increased control: One agreement only and maximum transparency with partnerships and capabilities.
5. Reactivity: Examples of “mission-critical” rescue projects PRC Clinical was involved in.

From mega-corporations to mid-sized firms, the majority of pharmaceutical and biotech companies are turning to contract research organizations to carry out the delicate, often complex process of bringing a drug to market.

The outsourcing model brings convenience and targeted services but involves the added dimension of combining in-house staff with contract teams — sometimes from multiple research organizations. Crews the size of a basketball team are all working under complex regulatory system with the odds of success stacked against them.

That makes finding the right contract research organization — often simply called a CRO — all the more important. So here is a checklist that narrows down some of the most important points to keep in mind.

 

Customer-centric: A project team built around your project, not the opposite.

That means staying away from the contractor who acts like, “We know what you want, we are the experts, now leave us alone to deliver,” as one executive with experience warned. It’s not an attitude that builds collaboration between the sponsor and project team members, or an approach that delivers results.

Collaboration built around the project is a key characteristic that client sponsors repeatedly say they value in a management team. Sponsors are looking for a team they can work with: one with the right chemistry and that is devoted to the study.

 

Direct access to experts: KOLs for your sites to support your study. Experienced team members and transparency with each person’s role.

One of the members you want to have on board is a key opinion leader (KOL). They’re often physicians who have the most contact with trial participants. They could also be academic researchers prominent in their field.  Either way, they can be a significant asset, able to contribute expertise about the trial and the underlying factors of an illness. Having KOLs in a study can encourage other investigators to sign on and, from the sponsor’s perspective, help lead to faster adoption in prescribing a new drug, said John Lewis, senior vice president of policy and public affairs with the Association of Clinical Research Organizations.

It is also important to note that KOLs should also be able to recruit patients for the study, which, Lewis said, “is what is most important from the CRO perspective.”

 

Functional Service Model: What is it? How to set it up and benefit from it?

Faced with the challenges of getting a drug through all the phases of a study, companies are taking an a la carte approach to hiring that is based on a specific skill. For example, instead of pausing to interview and hire someone to help with protocol design (or pay to keep someone on staff, which is expensive especially for small firms), a company can contract with a specialist who either has the needed skills for the job or can find the right person who does. The strategy is referred to as the functional service provider model and it’s becoming more common.

However, the model can easily backfire, costing more money than it saves, without putting in the time necessary to finding a good fit, Mary Jo Lamberti, senior research fellow at the Tufts Center for the Study of Drug Development, found. “Culture is definitely important.”

 

Increased control: Transparency with partnerships and capabilities.

CRO teams can be built to order, bringing together a collection of skilled and qualified professionals who have expertise in such specialized fields as data management and site monitoring.

But communication is just as important as the composition, Lamberti said. Transparency — giving sponsors more insight into the process — not only improves collaboration with sponsors, but also with sites, regulators and review boards. “Every CRO claims to be customer oriented, responsive, and so forth,” as another executive put it. “Exactly how a CRO proposes to carry out a project…now that can be convincing—or not.”

 

Reactivity: “mission-critical” rescue projects PRC Clinical was involved in.

The up-front work takes time but the investment in successful cases helps sponsor companies find the right vendor for their budget and instead of wasting time they were ready to start work.

Sometimes though things still don’t work out that way. For example, PRC Clinical was contacted by a US-based sponsor to help them recover critical study data. The sponsor had ended the contract with their existing CRO, leaving only 30 days to audit and retrieve study materials from the CRO, with Sponsor-CRO tensions running high.

The PRC Clinical team quickly created an audit plan, identified and assembled a team of experienced auditors for specific CRO transition reviews in the United States and the United Kingdom — simultaneously. That meant soothing a hostile situation and getting access to all the materials including critical study data. PRC Clinical gained access the contract organization at both sites, finished the audit and recovered the project records.

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