Statistical and programming

services for smart drug

development

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About Us

We are a team of statistical programmers, statisticians and analysists offering statistical and programming services to pharmaceutical companies and CROs. With 18 years of experience and over 300 analyzed studies under our belt, we can help you plan and complete a wide variety of clinical trials - at any phase and in any therapeutic area.

 

We focus on quality programming. We don’t simply run programs on your data: we understand your data, and find the most effective ways to uncover the information you need.

 

With our help you can analyze your studies faster and at a lower cost, while gaining deeper insights into what your data reallysays about your investigational product.

Services

We offer statistical and programming services at every stage of new drug development

Statistical Programming

Does your SAS programming team need help completing a project on time? Do you need a back-up team to handle an additional project at times of peak load? Do you need an advice on a particularly complex or unfamiliar situation? Our experienced consultant programmers can augment your team to boost your productivity.

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Biostatistic

Do you need help developing statistical section for a new protocol, or an SAP? Do you want to perform additional analyses of your data for a publication? Our statisticians can help.

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Experience

  • Our team has analyzed over 300 studies over 18 years

  • We have covered all development phases from 1 to 4 to post-approval publication support.

  • We have extensive experience with a wide range of therapeutic areas, such as CNS, infections, cardiovascular, oncology, skin diseases, respiratory, and many others

  • We are proficient with analyzing generic drug studies (acne, rosacea, tinea pedis, asthma)

  • We have executed numerous integration projects: ISS/ISE for NDA or sNDA

  • CDISC standards are applied throughout our process

300+ studies

ALL development phases

18+ yeats of experience

CDISC standards

Quality

  • Programming starts with specifications. Specs define analysis dataset structure.

  • Annotated table shells define table programming.

  • We always do 100% Quality Control by independent double-programming.

  • We conduct senior reviews before every delivery.

  • We perform code reviews to ensure coding is done correctly.

  • We use centralized status tracking, so that we always know which outputs are in progress, ready for validation, passed validation.

  • All procedures are documented in Standard Operation Procedures documentation and are strictly adhered to.

  • When working under the FSP model, our programmers will adopt your team’s process, SOPs and quality standards.

Quality is our top priority.

As a sponsor, you must be absolutely sure that

your analysis results are correct.

We take multiple steps to ensure the highest

quality:

Success stories

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