With the area of biostatistics representing a crucial part of the clinical trials sector, pharmaceutical companies are on the lookout to partner with innovative outfits able to slake their requests. Supported by a small team of experts, Valos is one such player, providing a range of statistical analysis and reporting services, as managing director Dr Dmitri Petratchenko explains.

As pharmaceutical players increasingly look to outsource parts of their clinical trials and drug development projects, companies able to provide innovative statistical analysis software (SAS) expertise and solutions are, in turn, rising to the fore.

Headquartered in Genoa, Italy – with a back office in Eastern Europe – Valos is one such company to have capitalised on the trend. In partnering with its clients, it offers on-demand comprehensive data management, biostatistics and statistical programming services for phase I-IV studies.

Strong foundation

According to managing director Dr Dmitri Petratchenko, who has over ten years’ experience as a senior statistical programmer and clinical SAS programmer, Valos has emerged as an attractive partner to pharmaceutical players due to the strong foundations of clinical and professional expertise that underpin the company.

"We are a small international team of SAS programmers and statisticians," he says. "All of our clinical research programmers come from strong educational backgrounds, and have good university degrees in mathematics, statistics or informatics. This is really the core of our company."

In fact, the team, as alluded to by Petratchenko, currently comprises only ten employees. However, while nominal in size, he believes this lends Valos a proximate advantage in being able to deliver a better quality of service that adheres to project deadlines.

"While we are not a big company by any means, our size does mean that we can easily adapt to our clients’ requests," he explains. "This is especially the case when it comes to bigger pharmaceutical companies with very specific demands for statistics and analysis. We really specialise in something big players need."

So, it is this ad hoc approach that lends Valos something of a competitive advantage?

"Yes, exactly," asserts Petratchenko. "While we may not be comparable in terms of numbers to some of our peers, we work on projects in a slightly different way. Instead of rushing in and not listening properly to the client, which some larger biostatistics companies are sometimes guilty of, we take our time, in order to make sure our programmes have the best fit possible."

Bespoke offering

Working in tandem with biostatistics departments, Valos’s range of bespoke services includes statistical analysis and reporting services; programming for ISS and ISE; data cleaning programmes and the validation of statistical programmes, tables and graphics analysis data sets.

"We really try to work closely with organisations to understand precisely what they are asking for," says Petratchenko. "This could be providing analysis that creates another database, conversion of data or just performing a straightforward validation service. Each biostatistics department has its own programme or environment, to which we try to align our services."

In addition to offering this range of solutions, Valos also pays close attention to following well-defined pharma industry trends and standards such as the Clinical Data Interchange Standards Consortium (CDISC) – the global multidisciplinary organisation that supports the acquisition, exchange, submission and archive of clinical research data and metadata.

"A lot of demands involve converting whole data to SDTM [study data tabulation model] and ADAM [analysis data model] structures, in line with CDISC instructions," says Petratchenko. "This is not only imperative for us, but for the industry as a whole – to understand data and convert it into a common structure."

While Petratchenko may claim that Valos’s ultimate differentiating factor is the company’s small size, he doesn’t rule out investing further in human capital in the coming years as a means of better serving the burgeoning field of clinical trials.

"While we have already enjoyed a lot of market success, we are, naturally, always looking to grow," he says. "Being based in Genoa, which has a university that excels in statistical studies, with Milan close by, we have plenty of scope to build upon what we already have."