In the end, clinical development comes down to biostatistics and words—words in the protocol, the study report, the regulatory filings, the drug label. In a global world, getting those words right can be no small matter.

“There are a lot of translation companies out there. Only a handful specifically specialize in life sciences and health care,” says Inna Kassatkina, co-founder and president of Global Language Solutions. “We happen to be one of those companies. We understand the pains and challenges of the clinical research industry. We understand the whole cycle of research and development as well as commercialization.”

She notes that the translation requirements of patient-reported outcome (PRO) instruments is a thriving niche in the industry, both in the U.S. and abroad.

Two Week Turnaround

As some readers may not appreciate, the process of back translation (translating a translated text to assess the original) can be a vital element of quality control. That extra step may prevent an unintentionally humorous or culturally insensitive phrase from reaching a physician, patient or regulator in another country. In one instance she’s aware of, another firm in the industry translated “keep out of reach of children” as “keep children from stretching.”

Says Kassatkina: “The trick to back translation is that the team of translators and editors are completely independent of the original translation team. Sometimes companies go to the extent of hiring not one but two companies.” But with 2,500 professional translators in her network, she doesn’t need to outsource anything. What’s more, her firm’s technology can keep track of pivotal, frequently used phrases and translate them consistently.

Another edge? Time. Global Language Solutions can usually deliver a full translation in two weeks, not the 6-8 weeks that can be typical of competitors. The women-owned firm is based south of Los Angeles, in Aliso Viejo.

RIsk Management

Even five years ago, she notes, translation and back translation were an afterthought at some companies. That’s changing. “Companies that cut back on the translation and back translation are ones that do not see that as part of their risk management strategy,” Kassatkina says.

Attuned to the exacting rigors of the industry, Global Language Solutions this year won ISO 9001:2000 certification. “It was a huge undertaking,” Kassatkina says. The process required an exhaustive documentation of the firm’s process, which involves editors, translators and proofreaders. “It’s not just one person working on the translation of a particular document,” she says. “It’s always a team of people that are working on the document together.”

She has learned to be cautious about hiring, assessing her translators’ abilities gradually. “The selection of these people is the most important aspect of the business,” Kassatkina says. “No matter how great your technology is, it’s still the people who do the translation. The quality eventually rests with the people who are assigned to it.”

Regulatory Linkage

Just how specialized are the people working for her? “They may have expertise in a therapeutic area,” she says. “The specialization does not stop in the industry. It goes into subspecialties of those therapeutic areas.”

Not long ago, the firm expanded its offerings to include regulatory consulting, partnering with David Bernstein. He’s a PhD chemist with thirty years of industry experience.

The nuances of the regulatory process in different jurisdictions, he says, require both linguistic and scientific sophistication. The process of translating drug labels for clinical trials, long prior to market approval, is a surprisingly complicated step in some trials, he reports. “One of the rate-limiting steps is how long that [label] translation takes,” says Bernstein. “Our process in the U.S. does not mandate that label text be submitted to the FDA. The FDA doesn’t even look at it. In the EU, by contrast, they look at it with a fine-toothed comb.”

Indeed, translation-related delays can even dissipate the initial enthusiasm that arises around trying to launch a trial in a new country. Those new to clinical research may not always grasp the scientific or cultural subtleties of the English label, much less the differences between the dialects of French as spoken in Montreal and Paris. Getting either language wrong can lead to lost time.

Flawed French

With Cyrillic or German character sets, even the physical space on a label may become an issue if the text cannot be fit into the space available. In the U.S., it’s fine to use tiny text. In Europe, in contrast, larger, easy-to-read 10-12 point fonts must be used. But those may require both cultural and linguistic adroitness.

And there are pitfalls that await any neophytes who are just learning the regulations around pharmaceutical research. “The wording is very, very particular,” Bernstein says. “You need to have someone in country who knows the medical or pharmaceutical lingo. If you put ‘expiry’ date into French, when you back translate it, it translates into date of death. That’s not something you want to get to patients.”

Bernstein says that a rigorous process of validating a translation with back translation is not always added to every clinical trial budget. He believes that strategy is risky. “Anyone who doesn’t do this is asking for accidents to happen. It’s an insurance policy.”