Making it Work

Making It Work: Quality is key to growing success of StatisticaMedica’s ‘boutique’ service

Dr Gloria Crispino’s small medical research company works with some of the biggest pharma and medical firms in the world, analysing the data from their clinical trials

Dr Gloria Crispino: ‘We employ 11 people, which might sound small, but 11 statisticians in a room is a lot of brainpower’

In Italy, where Dr Gloria Crispino was born, the most lauded form of entrepreneurship is the type that prizes slow, steady growth.

“My country values entrepreneurship that is slow, long-term and real,” Crispino, the founder of the Dublin-headquartered company StatisticaMedica, told the Business Post. “It’s very much about growing by quality and repeat business. All our work is repeat business, or referrals from our clients. We’re a boutique business, and we like it that way.”

You could argue that Crispino, who founded StatisticaMedica ten years ago, is being modest: her medical research company today works with some of the biggest pharmaceutical and medical firms in the world.

But it’s not a firm that wants to employ hundreds, according to Crispino, formerly a professor of biostatistics at the Royal College of Surgeons in Ireland.

“We employ 11 people, which might sound small, but 11 statisticians in a room is a lot of brainpower,” she said.

Rather than talking about rapid global expansion or revenues in the hundreds of millions, StatisticaMedica prides itself on the tailored service it offers to clients. Those clients include major clinical research organisations who outsource some of their work to Crispino’s company, as well as pharmaceutical businesses operating in Europe and the US.

When a company wants to release a new drug onto the market, it has to jump through various regulatory hoops. Arguably the most important one is the clinical trial, which is where StatisticaMedica comes in.

“We provide analysis of the data from the clinical trials. The company will collect the data and it then needs to be submitted to the notifiable body. We come into the process as early as possible to make it run efficiently from a statistical point of view,” Crispino said.

“We work in parallel with the rest of the team. While they are recruiting patients and collecting data, we prepare the programming for the tables, the figures and the outputs, which need to be produced as part of the process.”

The firm then produces statistical analysis on the data, evaluating whether it backs up the company’s assertion about it. “Every claim needs evidence to back it up,” Crispina said. “So the more claims, the more evidence you need.”

StatisticaMedica, which has support from Enterprise Ireland, works on trials of varying sizes, from experiments on a few dozen participants to ones with thousands of candidates, at this stage of the regulatory journey. It’s not a procedure that forgives mistakes easily.

“The clinical research industry is very rigorous, and there’s a lot at stake at every step,” Crispino said. “Accountability, consistency, integrity – these are all words we use every day in our business.”

In 2018, the firm set out to get the highest level of accreditation from the US Food and Drug Administration. “We are compliant with the most stringent regulatory requirements in both Europe and the US,” Crispino said. “For us, the biggest differentiator between us and our competition is quality.”

Because of its success, StatisticaMedica will need to grow out its operations in the coming months, and expects to hire 25 people by the end of the year. But it’s keen to do so sustainably, Crispino said.

“For us, there’s no point in competing with the big clinical research organisations – we want to keep offering this boutique service to our clients.”