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
Key Interactions Between Biometrics Teams for a More Efficient Clinical Trial
Discover key interactions between clinical data management and biostatistics teams for a more efficient clinical trial.
A Review of the 2024 Draft Guidance for DMCs
In early 2024, FDA released an updated draft guidance for data monitoring committees (DMCs).
Exploring the Characteristics of a High-Performing Medical Writing Vendor
What characteristics should you look for in your medical writing partner? We spoke with PharPoint's Associate Director of Medical Writing, Samia, to learn more.
How to Select Data Monitoring Committee (DMC) Members
Working to select members for a data monitoring committee? Explore criteria for member selection, training, and how to select a Chairperson.
History of Data Monitoring Committees
Learn more about the evolution and history of data monitoring committees, from the 1960s to today.
The Journey of Clinical Trial Data Points: From Patient to TLFs
Learn more about the journey clinical trial data takes before ending up on the package insert of a drug you're taking.
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