PARTNERING WITH PES

All CROs say they are focused on data quality. Clinical trials present conflicting objectives, however, when CROs are faced with running compliant on-time studies while also providing the highest quality endpoint data possible. Too many trials become doomed by bad or inconsistent data.

 

Sponsors need an independent partner focused solely on the clinical endpoints. PES is built to ensure that your pipeline assets are given the fairest opportunity to demonstrate efficacy. You shouldn’t settle for anything less.

Results & Risks

There is too much at risk when you rely solely on a contract research organization (CRO) to independently run and manage your clinical trial. When you partner with PES, you are assured that your clinical trial has the best chance of success.

CRO Only

Potential for missing data, uninterpretable data, & inconsistent data

OR

Partnering with PES & CRO

Complete subject datasets, analyzable and interpretable

Although most CROs are well-equipped to successfully run a clinical trial, they lack the independent thoroughness and indication expertise that PES provides.

CRO Only

Partnering with PES & CRO

Study Design & Endpoint Selection

Medical writers drive and coordinate protocol development focused on submission format and regulatory guidelines
Expert clinicians assist in the selection of study endpoints with careful consideration of the clinical, regulatory, and commercial meaningfulness

Customized Web-based Training

Training of key investigators at the outset of the study; costly in-person site training with no retraining available
Custom training modules for all study personnel, translated to the local language of each study site; web-based training designed to optimize data collection accuracy and uniformity

Real-time Endpoint Review

Data collection happens as part of basic trial management, focused on regulatory compliance; general monitoring for safety and adverse events
Real-time EdQ™ assessment of every subject observation, focused on completeness and consistency; gaps are flagged and sites are immediately contacted

Centralized Scoring

The observations of study patients are interpreted, recorded, and scored by individual site assessors
All patient observations are reviewed and assigned scores by an indication expert at PES, removing site- and clinician-based variability

Study Metrics

Clinical Research Associates (CRAs) focus on accrual, maintaining trial timeline, and trial management
Provide CRO with metrics to optimize study subject retention and accrual; dropout monitoring and analysis

Click on the following infographic to view all of the PES and CROs comparisons.

Primary Endpoint Solutions CRO Clinical
About Primary Endpoint Solutions​

PES’s integrated services eliminate inconsistent and incomplete trial data, ensuring that the selection, capture, accuracy, and analysis of endpoints is optimized.

© Copyright Primary Endpoint Solutions 2019

Contact​

313 Pleasant Street

Watertown, MA 02472

info@pesclinical.com