Data Management and Biostatistics Functional Service Provider (FSP) Solutions

Whether it’s additional support staff for the day-to-day or a senior resource providing functional oversight – align with a CRO fully dedicated to your project’s success.

Why Choose PharPoint for your Data Management and Biostatistics FSP needs?

Expertise you can count on

With deep expertise in their functional areas, our staff integrates seamlessly with your team to deliver quality from day one.

Study team consistency

Always know what to expect and who to count on with fully dedicated PharPoint resources and low employee turnover.

Flexible, tailored study support

Whether you need support staff, a small team, or a senior expert to provide functional oversight on your behalf – PharPoint can flexibly meet your needs.

Working with our Data Management Teammates

Since 2007, PharPoint’s data managers and database programmers have provided Phase 1-4 data management support for clients of all sizes. Since 2007, we’ve supported 250+ studies across all major EDC systems, including Medidata, Veeva, and Medrio.

Capabilities Include:

  • Strategy and set-up, including preparation of data management documents; database design, build and testing; and eCRF design
  • Execution, including medical coding; data cleaning, reconciliation, and query review; and support for database lock
  • Technology support, including the ability to deploy, validate, test EDC systems and provide study team training for most common EDC systems
  • Oversight, including dedicated high-level support and strategic guidance to manage a data management team or other CRO

Working with our Biostatistics Teammates

Work alongside an experience biostatistician or statistical programmer that can help you plan with your end goals in mind and execute swiftly to ensure high quality analyses. Our biostatistics group has supported 1,000+ clinical trials, and all PharPoint biostatisticians have advanced degrees.

Capabilities Include:

  • Study design and planning, which may include sample size calculation; study simulations; endpoint strategies; the creation or review of a randomization schedule; statistical analysis plan (SAP) creation; and the review of data management documents.
  • Data monitoring committee (DMC) support, which may include statistical support for DMCs; DMC member identification; the creation of a charter; or ongoing administrative support for DMC meetings.
  • Analyses and reporting, which may include the development of SDTM and ADaM datasets; the programming of tables, listings, and figures; or regulatory submission support or statistical representation.

What PharPoint’s Clients Have to Say About…

Our Biometrics Expertise

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Our TEAM ALIGNMENT

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Learn why our team of experts has been trusted to support 1,000+ clinical trials.

Frequently Asked Questions

PharPoint has worked with sponsors of all sizes since 2007 to provide functional support within data management and biostatistics. We’ve supported over 1,000 clinical trials across all study phases. For more information about our specific experience providing data management and/or biostatistics support for studies like yours, please reach out to our team.

Yes. PharPoint operates flexibly to suit a sponsor’s needs, including flexible resourcing.

PharPoint’s data management team has experience with all leading EDC systems, including Medidata, Medrio, Veeva, and others.

Our biostatistics and statistical programming group has used the study data tabulation model (SDTM) and the analysis data model (ADaM) for implementation in regulatory submissions for over a decade. PharPoint’s SAS programmers follow the most current SDTM implementation guidelines released by CDISC to standardize study data and the SDTM annotated CRF.

 

Tells us about your data management and biostatistics FSP needs

Complete the form below and a member of our team will follow up via email shortly to discuss your study needs and schedule a 15-30 minute capabilities call.