Transforming Pharmaceutical Data Into Meaningful Reports for FDA Submissions

Navitas Data Sciences - Our Capabilities
 

We Provide Full-Service Solutions for Your Clinical Reporting Needs

 
  • Programming support in compliance with 21 CFR Part 11

  • Biostatistics/Statistical Analysis Plan

  • Analysis Dataset Generation

  • CDISC, SDTM & ADaM Mapping/Generation, and Define.XML

  • Tables, Listing and Graph Development

  • Verification/QC/Validation Programming

  • PK/PD Support

  • SAS Macro Development and Programming

  • Statistical Computing Environment Assessments

  • Data Migration and User Acceptance Testing

  • Legacy Data Transformation and Visualization

  • Clinical Study Report, ISS/ISE and Annual Report Support

  • Registry, Post Marketing Data Analysis, Manuscript Support

SAS Programming and Biostatistics
QC and Validation
CR Toolkit™ & SAS Macros
Data Migration and User Acceptance Testing
Legacy Data Transformation and Validation
Registries/Data Requests

 


Centers of Excellence


Why Industry Leaders Rely on DataCeutics

Our team of professional programmers is adept at handling every aspect of statistical programming for the Biotech and Pharmaceutical Industry. In addition to our routine work, we have the skill set and experience to handle the unexpected requirements that arise from data and clinical trials.

No matter how large and what phase of your study, our work is completed with the utmost precision and accuracy. The experience level of our programmers, coupled with a remote-worker status, provides for a very advanced, efficient and smart work model, resulting in significant cost savings to your organization.

SAS Partner (1993) • CDISC Platinum Member (2003)

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EXPERIENCE + EDUCATION = RETENTION

Recruited by DataCeutics’ specialists, every member of our US-based workforce is required to score at least 95% on the company’s proprietary SAS Statistical Programming Exam as well as on our proprietary oral communication, writing, and grammar exams.

 
Photo by Ryan McVay/DigitalVision / Getty Images
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Education

Experience


25

Years in Business

23

Therapeutic Areas

90%

Repeat Business

94%

Employee Retention


  Testimonials

"DataCeutics consistently provides high technical statistical programming skills.Their programmers successfully apply their knowledge of SAS and clinical data to our Registries (which differ greatly to standard clinical trials). DataCeutics provides a wide range of programming tasks – they are not limited to typical analysis datasets and TLFs. They also provided UAT (User Acceptance Testing) test plan creation, program development, implementation, and documentation during our legacy migration to our physician portal reports and SAS extracts. They consistently meet all timelines/deadlines with accuracy. DataCeutics is always professional, clear and concise in their written and verbal communications. Every aspect of working with DataCeutics is fantastic."

-- ASSOCIATE DIRECTOR, STATISTICAL PROGRAMMING, BILLION DOLLAR BIOTECH COMPANY

 

"I just wanted to send a quick note to let you know how great it's been to work with Ms. G! The studies are challenging, and she's been amazing throughout it all.  She has excellent technical skills and provides great feedback on ways to improve efficiency. She takes initiative and astutely addresses challenges by developing programming workarounds and debugs complicated macro programs. The work she does is incredibly high-quality, detail-oriented, and comprehensive. She has also been a tremendous asset for the QC function.   On top of her amazing work and dedication, Ms. G has a great personality and is such a wonderful colleague!"

--Statistical Analyst/Manager, A Leading Biotech Company with Multiple Products on the Market