Clinical trials are extremely expensive, yet many rely on clinician-based assessments that are inconsistent at best. As challenging as it is to bring a new drug to market, one thing should be fundamental: You can’t afford bad incoming data.
Through the dynamic real-time review of incoming subject data, PES moves forward any data problems that typically come at the end of a trial – this has many benefits:
All CROs say they are focused on data quality. Clinical trials present conflicting objectives, however, when a CRO is faced with running a compliant on-time study while also capturing the highest quality data possible. The result: Too many trials become doomed by bad or inconsistent data.
PES fills an important gap. Sponsors need an independent partner focused solely on the endpoints. We are purpose-built to help you save money and mitigate risk by getting it right the first time. Through our integrated set of services, we guarantee the highest quality data for our clients.
“PES provides therapeutic expertise that we recognize as vital to the accurate interpretation of incoming trial data. They’ve been a valued collaborator on several clinical trials.”
– Clinical Operations Manager, CRO
There is too much at risk when you rely solely on a 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.
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.
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.
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.
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.
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.