Local Expertise is Critical Ingredient, So Fully Vet CROs Before Signing Contracts


By Shaylyn Pike,
Senior Research Analyst

Pharmaceutical companies’ global clinical development strategies are diverse, but there are some points of agreement: clinical trials in emerging markets are more successful when companies hire local expertise. Generally speaking, this often means local vendors familiar with the markets they serve. But not all vendors — global or local — are guaranteed to own the knowledge they claim. For pharmaceutical and biotech companies looking to establish and expand their presence in emerging regions, lack of experience can result in being scammed by CROs and other vendors who promise to deliver regional expertise. Sponsors should not blindly accept statements from these companies because some vendors may overemphasize skills in order to win contracts.

One company I recently spoke with gave an example: “We hired a Croatian IP import vendor, and they advised us wrong on the IP import processes at that time. That caused us to lose the study. We’re working back to where we were, but that’s my cost. I learned. Now, when looking for an IP import vendor in Bosnia-Herzegovina, we discovered that only one of four vendors knows the right processes, regulations and standards.”

Another executive I had a conversation with narrated her experience working in Russia: “We hired a multinational CRO with an office in Russia. They gave us the impression that there was no opportunity to talk to Russian authorities to explain submissions. They told us the only thing we could do was keep writing responses to questions and resubmitting. We would have to sit and wait until they came back with a response, and then we would write more answers and send those. They claimed there was no opportunity for dialogue.”

The executive talked to her colleagues at other companies and discovered that the contact at the multinational CRO was misinformed. They directed her to a different multinational CRO with local Russian regulatory experience. From that point, the trial ran smoothly. A different interviewee cautioned that sponsors must ensure that the local people working on their trials also own local knowledge. “Just because they are Bulgarian does not mean that they have Bulgarian knowledge.” Sponsors’ best bets are vendors that bring a mix of local and Western-trained employees.

But what are the best ways to do this? After talking with several clinical trial executives, our team identified the following guideposts:

1. Ask Tricky Questions

Running clinical trials in an emerging market requires a wide range of knowledge — from the ins and outs of the local healthcare system to understanding the regulatory guidelines to building relationships with key physicians in the region to specific therapeutic area expertise. Each trial will require a different set of qualifications. To make sure a vendor or CRO is qualified to run your trial, ask them to prove it. These tricky questions fall in one of two areas:

  • Proof of process knowledge. Ask the vendor to describe each step in the process instead of asking if they have knowledge of the process. Detailed explanations are tougher to bluff through.
  • Fact checking. Research the most-concerning aspects of the process as the sponsor. Then ask pointed and varied questions to verify knowledge of all parts.

The first type of question is often less confrontational, while the latter can suggest ignorance on the part of the vendor. Many companies find success by combining aspects from both in an overall CRO due diligence. Quality local expertise will understand the need for thorough due diligence.

2. Talk Face to Face

A U.S. executive recommends finding contacts that “you can establish a personal connection with.” She traveled around the world to talk to potential vendors. “The personal connection may be intangible, but it is invaluable,” she stated. Especially when working with different cultures in different regions, personal communication helps to clarify what knowledge the vendor owns. Email allows researched answers and more accurate English; being put on the spot, however, may be a truer barometer of language ability, regulatory knowledge, cultural differences, etc.

3. Look for a Vendor Willing to Tell You You’re Wrong

Too often, eagerness overrides competency in negotiations with CROs — on the part of both the CRO and the trial sponsor. The sponsor may insist on timelines or protocols that no CRO could meet in that market, and CROs may exaggerate their abilities in an effort to close the contract. When this scenario happens, the CRO wins the contract but the trial falters.

Companies should look for CROs that are willing to tell them when they are mistaken. Is the regulatory timeline realistic? Does the clinical protocol reflect patients in the country? If not, quality CROs will step in and provide insight based on their experience; as the knowledge experts, this is their responsibility. If a CRO cannot bluntly provide this insight, they should not be trusted with managing your trial.

Conclusion

Local expertise is crucial to your trial. According to several interviewed clinical executives, it can even make or break it, so make sure you find the highest quality CROs and vendors to work on your clinical trial.
 

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Published May 4, 2012


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