CLINICAL TRIAL SERVICES
Biostatistics CRO services
With PharPoint’s biostatisticians and statistical programmers, clients receive access to our:
EXPERIENCED TEAM
PharPoint’s biostatistics team has been trusted by clients since 2007. All of PharPoint biostatisticians hold advanced degrees.
INDUSTRY-BEST TIMELINES
PharPoint’s biostatistics team works diligently to expedite the delivery of study results. Our standard timelines include the delivery of top line results two days after database lock, and the delivery of draft TLFs three days following.
REGULATORY EXPERIENCE
PharPoint’s biostatistics team has supported over 30 regulatory submissions and has experience supporting discussion with regulatory authorities, including type A, B, and C meetings.
PharPoint’s biostatistics CRO services include:
- Randomization
- Regulatory and advisory meeting support
- Statistical analysis plans (SAP)
- Statistical analysis and support services for interim, futility, and Data Monitoring Committee (DMC) analysis
- Integrated summaries of safety and efficacy
- Preparation of case report tabulations (CRTs)
- Quantitative epidemiology including patient registries
EXPLORE RELATED RESOURCES
Four Signs It is Time to Break Up with Your Regulatory Medical Writing Vendor
Explore some of the standards should you expect from your regulatory medical writing partner.
Standard Clinical Trial Timelines: A Sponsor’s Guide to Evaluating Biometrics CROs
This brief guide provides timeline benchmarks for Sponsors evaluating biometrics contract research organizations (CROs).
Developing a Comprehensive Yet Concise DMC Charter
Discover what an effective DMC charter should look like and what contents are required with PharPoint DMC coordinator Victoria.
Clinical Trial Design: Ensuring Statistical Validity and Identifying Consulting Biostatisticians
Why engage a biostatistician early in the study design process, and how do you identify the right consultant for your study?
Statistical Support for Regulatory Submissions and Confidently Navigating Regulatory Discussions
How can an experienced biostatistician provide critical support before and during the regulatory submission process?
The Rising Need for Data Monitoring Committee Member Training
Exploring industry perspectives and insight regarding data monitoring committee member training with PharPoint DMC coordinator Victoria Elder.
OUR UNIQUE APPROACH
All PharPoint clients receive custom programming. Why?
Personalization
Clients receive programs catered to their study needs and preferences
Pricing transparency
No hidden fees due to use of proprietary compiled macros
Transferability
Clients have the ability to use PharPoint programming to create datasets and TLFs in-house
Submission readiness
Programs can easily be packaged as part of regulatory submission