Case Studies and Testimonials
Explore case studies and testimonials from clients who’ve experienced the difference of working with a contract research organization (CRO) that is committed to their goals.
Featured Case Study
Case Study: Proactive Risk Mitigation in Early Phase Oncology
This case study highlights how the PharPoint team supported a Phase 1 FIH oncology study that completed LPLV and database lock ahead of schedule ...
BRINGING A STUDY BACK ON TRACK
A Big Rescue for a Study with the Tiniest of Patients
In this full service rescue, we took over a neonatal cardiovascular study from an underperforming CRO. Our experts worked with the sponsor to address issues with their previous CRO and set clear timelines and budget goals. This took into consideration the complexities involved in enrollment for neonatal patient populations.
PharPoint’s team recreated 7+ study plans and an additional 20+ site documents as part of this rescue.
SUPPORTING GROWING PORTFOLIOS
Providing Support Throughout the Drug Development Process
PharPoint has extensive experience supporting growing client portfolios. For one client, PharPoint has provided data management and biostatistical services for over 13 years. PharPoint was initially brought on for Phase 1 services, and provided support throughout the drug development process – including two successful NDA submissions which were approved by the FDA.
Studies varied in duration and had multiple DMCs, DSURs, and interim analyses. With numerous deliverables across differing programs, our team used frequent communication, cross functional input, and a focus on ensuring consistency to produce quality results efficiently and effectively.
SUBMISSION SUPPORT
Legacy Dataset Conversion & a Successful Submission and Approval
As part of a large integrated analysis involving 27 studies, PharPoint mapped 26 legacy datasets into SDTM. Re-coding was needed for 18 studies. Individual ADaM datasets were generated from the integrated ADaM datasets, and a validation of the integrated ADaM datasets used the original derived datasets as the source for the validation programming.
The result of this legacy dataset conversion and integrated analysis was a successful submission and approval.
CLIENT:
Global biotechnology company
SERVICES PROVIDED:
Data management, biostatistics
“The team members, the communications, the hard work and dedication of the PharPoint staff is all second to none. We work globally and the team has on occasion worked extremely hard outside of normal business hours to assure the study was taken care of and milestones were met. “
VP Clinical Operations
CLIENT:
Small rare disease company
SERVICES PROVIDED:
Clinical operations, data management, biostatistics
“After a less than positive experience with a large CRO, we knew we needed a CRO who was vested in our collective success, a true and trusted partner who would be flexible, attentive and engaged in achieving our end goal. We also needed to work with an experienced, competent team who we could rely on and an approach to the contracting that offered value, without compromising quality. In our partnership with PharPoint we have found all of this and more.“
General Manager