Data Sciences

High quality Clinical Data FSP support

Explore our offerings

Biostatistics Services

Expert biostatistics support for trial design, protocol development, data management, study monitoring, and more.

Statistical Programming

Your reliable data scientists for key data insights that power better decisions to drive successful outcomes.

PK | PD Support

Our extensive PK/PD support will help you run efficient clinical trials following Global regulatory standards.

Data Management

We ensure audit-ready clinical data documentation with quarterly reviews, personnel training and currency reviews.

CR Toolkit

Our CR Toolkit™ enables you to work on study reports efficiently, helping you access your data accurately and consistently

Navitas Life Sciences Provides A Global FSP Solution for All Your Biostatistics, Statistical Programming and Data Management Needs

DataCeutics was acquired by Navitas Life Sciences in 2019 and is now Navitas Data Sciences (NDS). NDS is now the Functional Service Provider (FSP) division of Navitas Life Sciences. NDS supplies teams of highly skilled Data Managers, Statistical Programmers (both US-based and Global Programmers) and Biostatisticians. NDS has always provided skilled employees to meet our client’s needs. No matter the size and phase of your study, our work is completed with the utmost precision and accuracy. The experience level of our professional resource, coupled with a remote worker status, provides for an advanced, efficient and smart work model, resulting in significant cost savings to your organization.

Our Functional Service Provider (FSP) Model Drives Better Outcomes for You

NDS FSP Model provides for continuous interaction with its employees, providing support, training, supervision, timeline management, budget management, and mentoring. NDS has been creating teams who are dedicated to our clients, taking into consideration the staffing needs and timelines. The dedicated team works only for one client. Each team has a Project Manager or Lead and depending on the size of the team could have both. The Project Manager reports into an Executive Manager. The Project Manager is the direct contact with the client. The key is that NDS places professional, experienced, competent managers in the chain of command who take responsibility for all aspects of the work from resource allocation, to timeline management, budgeting, and quality control. A Governance Plan will be put in place to manage communication and any issues.

The Navitas Life Sciences Edge – The Perfect Combination of Experience & Expertise

Over the last 25 years, we have assisted our customers with over 150 drug submissions. We are a SAS Partner since 1993, and a CDISC Platinum Member as well. Our team of experts ensures that your Biostatistical, Statistical Programming and Data management delivery is of a high quality and complies with the most rigorous standards.
Our US team have experience working on projects in various therapeutic areas. We will work with you to match your needs with the appropriate expertise.
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PHASE I

PHASE III

PHASE II

PHASE IV

We support all clinical trial phases throughout the drug development lifecycle.

Our Biostatisticians, Statistical Programmers and Data Managers are Carefully Screened to Ensure Excellent Output and Seamless Collaboration

The diversity of our US employee’s strong expertise allows Navitas to efficiently solve challenging problems and deliver consistent results on time. Our US staff have an average of 19 years' experience. Most of our team has worked in the industry for over 15 years, with 60% having over 20 years of experience.
Our experts communicate seamlessly with your team to ensure delivery excellence. Every member of our Data Sciences team is required to score at least 95% on the company’s proprietary Statistical Programming Exam, as well as on our proprietary oral communication, writing, and grammar exams.
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Our Success Stories

Major Pharma (Statistical Programming–FSP Model)

  • Offered Biostatistics & Statistical Programming Support (FSP)
  • Engaged in a 20-Year Plus Contract with Customer
  • Achieved Preferred Vendor Status
  • Assigned Team of 33 Data Resources (Programmers, Biostatisticians and Project Managers)
  • Supported Over 40 drug submissions
  • Allocated Staffing according to Ebb and Flow of Work
  • Helped customer realize 20% savings in programming services

Global Biotech (Statistical Programming–FSP Model)

  • Offered Biostatistics & Statistical Programming Support (FSP)
  • Engaged In a 13-year project
  • Achieved Global Support Team
  • Assigned Team of Programmers (varied yearly 10-32), Project Managers (varied 1-4 depending on workload), and Biostatistician
  • Supported Over 33 Drug Submissions
  • Performed 100% Focused Validation Work and Identified Errors (22%) Each Year

Our CR Toolkit™ SAS Macro Library Enables Your Organization to Expertly Work with Study Reports, Consistently and Accurately, Every Time

The CR Toolkit™ SAS macro library facilitates preparation of reports conforming to sponsors’ standards. It enables you to assemble and produce consistent reports. You can work with any data structure and content, and it supports CDISC standards (ADaM and SDTM). Over multiple studies and the long path to submission, many things can change including protocols, personnel, and reporting requirements. These changes will affect your data, and in turn, the information for your submission - reports.

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The CR Toolkit reduces lines of code & development time by over 50%, reduces variability by standardizing statistical operations, enables consistency throughout your programming environment, streamlines QC process and adds validation.

Standardization

Standardization

SAS Macros that have been tested by experienced programmers are used with datasets organized in standard formats.
QC System

QC System

Quality control becomes a clear process that enables efficient review and management of tables, listings, and graphs output by the SAS macro library.
Consistency

Consistency

Standardized code and a consistent QC process create macro outputs with higher quality and fewer errors.
Reliable Validation

Reliable Validation

The combined result of macro standardization and process control is simplified, reliable validation process that ensures your deliverables are correct and ready for submission.

Our Centers of Excellence Ensure High-Quality Outputs

CDISC
Our CDISC expert has 25 years of experience as a SAS Programmer and 13 years in CDISC- since its inception. Our expert provides continuous improvement in CDISC by keeping our resources trained in CDISC standards and keeps us current with the latest requirements for SDTM, ADaM, Define.xml and the Reviewers' Guide.
Statistical Computing Environment (SCE)
Processes, Procedures, People and Tools are the focus of SCE assessments. The SOPs may be similar from company to company however, it is the unique programs and activities of the sponsor that make each assessment unique. With over 25 years in the industry and our strong commitment to process, procedures and methodologies, we excel at assessing your compliance with 21 CFR Part 11.
CR Toolkit™ & SAS Macro Development
Navitas Life Sciences delivers a 50% reduction in lines of code. Our CR Toolkit delivers a consistent and tested set of code that produces reports for your FDA submission quickly and effectively. We enable you to accelerate your submissions while ensuring the highest standard outputs.
Statistical Programming
Our SAS programmers are seasoned, self-starters with 10 years or more of programming experience. We deliver outcomes that enable the last mile to submission, ensuring that your data is presented clearly and the impact is conveyed effectively.
Registry Programming
Registries  provide the basis for sponsors' research.

Our SAS programmers work on large datasets and with methods for presenting data in SAS. In close collaboration and dialogue with the sponsors' staff, the SAS programmer will participate in the drafting of scientific papers and publications within clinical epidemiology including programming and analyzing clinical indicators that show the information pertaining to the product.
Biostatistics
For the biostatistician, the Statistical Analysis Plan (SAP) defines and delineates all statistical methods and analysis outputs in the Clinical Study Report.

The work of the biostatisticians is focused on sample size and power estimations, rules for handling missing data, definitions of populations, interim statistical analysis, methods for analysis of efficacy endponts.
PK/PD
The information gained from the results of ongoing PK analysis during a clinical trial is invaluable for both monitorings and for compiling FDA submission reports on both the safety and efficacy of very many experimental drugs.

Our programmers sort out data from various sources, convert them into standard format, gather all variables, organize them into specified structure, derive further variables and handle outliers/missingvalues/error data based on specific requirements. The entire process is normally very time consuming and resource demanding, therefore, we ensure we provide programmers that are very persistent and knowledgeable.