SynteractHCR is an international full service CRO valued at $1.5 billion. It has conducted Phase I-IV studies on 6 continents and in more than 60 countries across a broad range of therapeutics areas.
Synteract works with a range of different clients from small startup biotechs to large established global pharma companies. To satisfy the requirements of such diverse clients, SynteractHCR needs to have a wide variety of clinical trial software available.
In particular, they needed a validated sample size and power analysis application that can calculate the correct sample size for a wide variety of clinical trial designs with complete confidence for regulatory approval.
SynteractHCR assessed the market and selected nQuery as their dedicated sample size and power calculation software of choice. nQuery plays an important part in Synteracts clinical trial technology stack. As a full service CRO, their ability to produce accurate and validated sample size calculations cannot be compromised. nQuery is highly regarded with regulatory bodies as a robust, validated and reliable tool - all with zero coding required by the user. Synteract can use these to it's advantage for it's different sized clients.
Benefits of nQuery as sample size sofware for CRO's
By embedding nQuery into their technology stack, SynteractHCR enjoys many benefits. They have been able to continue to rapidly grow their capabilities by offering a full suite of services. This now includes Study design | Randomization planning | Establishment of priorities | Sample size estimation | Selection of end points for FDA , EMA and PMDA | Determination of appropriate analysis | Statistical analysis | Multiple-country submissions
- Validated Sample Size Estimation added to their suite of services
Using nQuery as their dedicated sample size estimation and power calculation software, Synteract can confidently calculate the appropriate sample size for their clients while preventing under/over enrollment in their clinical trials. This can be achieved with zero coding to save time and money be used in conjunction with other statistical software.
- Small to Mid-Sized Biotechnology Clients
With nQuery, SynteractHCR can assist smaller and mid-sized Biotechnology companies who may lack resources or expertise in biostatistics. Working with the expert SynteractHCR biostatistics team from the outset of a trial, using nQuery for sample size calculation helps inform all stages of their trial going forward.
- Larger Pharmaceutical Clients
SynteractHCR biostatisticians can effectively collaborate with the client’s own team to cross-reference trial designs and calculations to optimize sample size and power calculations for clinical trial success. As 45 out of the top 50 large pharma companies are extensive nQuery users, collaboration using the same validated software has obvious benefits. One such benefit is Synteracts ability to quickly share and demonstrate calculations but also demonstrates commitment to clients that they are using the industry leading software for sample size determination.