With demand for Clinical Data Interchange Standards Consortium (CDISC) compliance increasing, Clinical Trials Insight talks to Andrea Parodi, statistical programmer at Valos, about the benefits of automation, and improving a sponsor’s competitive standing.
What does automation entail? What are the benefits and how much uptake do we see today in the industry?
Andrea Parodi: Automation is key in clinical research. Following the standards by dealing with the same database structure means working in a much simpler, faster way. You know exactly where to find the information you need for producing results, and working faster means keeping things cheap.
Even if a sponsor wants to assign only a part of their analysis to a company like Valos, the sponsor and the company can benefit from working with a unique standard.
What role does Valos play in the market, and what is your position and experience?
Valos is a small company that provides biostatistics and programming services for clinical trials; our clients are pharmaceutical companies and clinical research organisations located all over Europe. If a company needs to outsource a part of a clinical trial, we are the partner they can count on.
I’m a statistical programmer in charge of following the conversion of the original data in Clinical Data Interchange Standards Consortium (CDISC) standards – such as study data tabulation model (SDTM) or analysis data model (ADaM) – and then producing tables, listings and figures based on the needs of the client.
My previous experience was at university and at pharmaceutical companies, as is true of most of my colleagues.
There is a growing demand for CDISC compliance and standardisation; what does it entail, and how big an issue is this in the industry?
The demand for complying with CDISC standards has increased in recent years, but we’ve been experts since the start. This is not an issue for pharmaceutical companies that outsource the statistical part of clinical trials, it’s an issue for contract research organisations (CROs) and statistical companies that have to learn how to work compliantly with CDISC standards. We are at the forefront in this.
How can leveraging biostatistics and statistical analysis system (SAS) programming influence a sponsor’s competitive standing?
Leveraging biostatistics and SAS programming means results can be produced in less time, and submission to EMA or FDA can be made as soon as possible. The authorities also have a great advantage in checking data that is in the CDISC format because it’s simpler and faster. This also brings benefit to patients, who will have the drug they need in as short a time as possible.
Can you tell us about the products Valos offers? What competitive advantages do they have?
We have two main lines of business. The first is statistical programming in SAS and R languages, which includes data analysis, reporting results with production of tables-listings figures, CDISC data conversion, double independent validation and programming support of every kind.
The second is biostatistics services like protocol design and review (for clinical trials and retrospective analyses), sample-size calculation, case-report-form design and development, statistical-analysis planning, integrated summary of safety/integrated summary of efficacy and support to publication.
We are not a huge organisation, so we can always focus on the sponsor’s needs and work as a part of its team using processes that match the sponsor’s system.
We also have a back office in Eastern Europe where we employ highly qualified programmers, all of whom hold a university degree in mathematics or informatics.
The small size of the company, as well as our back office, help us to be competitive in the market, in terms of quality as well as price.
